-
1
-
-
85148919095
-
-
FDA 101: Biological Products; FDA website
-
FDA 101: Biological Products; FDA website, www.fda.gov/forconsumers/consumerupdates/ucm048341.htm
-
-
-
-
2
-
-
85148916549
-
-
EMA News (15/08/2016): Better Monitoring of Biological Medicines – New Chapterin Guidelines on Good Pharmacoviligence Practices
-
EMA News (15/08/2016): Better Monitoring of Biological Medicines – New Chapterin Guidelines on Good Pharmacoviligence Practices; www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/08/news_detail_002590.jsp
-
-
-
-
3
-
-
85148924433
-
-
Health Canada: Abbreviations/Definitions; Health Canada website, www.canada.ca/en/healthcanada/services/drugs-health-products/drug-products/applications-submissions/guidancedocuments/clinical-trials/abbreviations-definitions.html
-
-
-
-
4
-
-
85148916410
-
-
FDA Center for Biologics Evaluation and Research History: 100 Year of Biologics Regulation(2002); www.fda.gov/aboutFDA/history/forgshistory/historyoffdascentersandoffices/ucm2017807.htm
-
-
-
-
5
-
-
85148926889
-
-
www.cdc.gov/measles/about/history.html
-
Center for Disease Control and Prevention (CDC) Measles History; CDC website, www.cdc.gov/measles/about/history.html
-
-
-
-
6
-
-
85148927743
-
-
www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/default.htm
-
FDA Vaccines, Blood & Biologics: Approved Vaccine Products; FDA website, www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/default.htm
-
-
-
-
7
-
-
85148922929
-
-
www.fda.gov/aboutfda/history/forgshistory/historyoffdascentersandoffices/ucm2017807.htm
-
FDA Center for Biologics Evaluation and Research History: Science and the Regulation ofBiological Products Preface (2002); www.fda.gov/aboutfda/history/forgshistory/historyoffdascentersandoffices/ucm2017807.htm
-
-
-
-
8
-
-
85148922507
-
-
www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/default.htm
-
FDA Vaccines, Blood & Biologics: Fractionated Plasma Products; FDA website, www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/default.htm
-
-
-
-
9
-
-
85148927261
-
-
www.fda.gov/AboutFDA/History/ProductRegulation/ucm593465.htm
-
FDA: Historical Case Studies of Drug Regulation : Celebrating a Milestone – FDA’s Approvalof the First Genetically-Engineered Product (2007); www.fda.gov/AboutFDA/History/ProductRegulation/ucm593465.htm
-
-
-
-
10
-
-
85148918714
-
-
www.phrma.org
-
Pharmaceutical Research and Manufacturers of America (PhRMA) website; www.phrma.org
-
-
-
-
11
-
-
85148917877
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S6_R1/Step4/S6_R1_Guideline.pdf
-
ICH S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals S6(R1)(June 2011); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S6_R1/Step4/S6_R1_Guideline.pdf
-
-
-
-
12
-
-
85044644137
-
Market watch: Top drugs and companies by sales in 2017
-
April
-
Urquhart, L., Market Watch: Top Drugs and Companies By Sales in 2017; Nature ReviewsDrug Discovery17, 232(April2018); www.nature.com/articles/nrd.2018.42
-
(2018)
Nature Reviewsdrug Discovery
, vol.17
, pp. 232
-
-
Urquhart, L.1
-
13
-
-
85148922142
-
-
www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm
-
FDA Drugs: Biosimilars; FDA website, www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm
-
-
-
-
14
-
-
85148921350
-
-
www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_001832.jsp
-
EMA Human Regulatory: Biosimilars; EMA website, www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/general/general_content_001832.jsp
-
-
-
-
15
-
-
85148925140
-
-
www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/biosimilar-biologic-drugs.html
-
Health Canada Drugs and Health Products: Biosimilar Biologic Drugs; Health Canada website,www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/biosimilar-biologic-drugs.html
-
-
-
-
16
-
-
85148922760
-
-
www.who.int/biologicals/biotherapeutics/similar_biotherapeutic_products/en
-
WHO Biologicals: Similar Biotherapeutic Products; WHO website, www.who.int/biologicals/biotherapeutics/similar_biotherapeutic_products/en
-
-
-
-
17
-
-
85148915449
-
-
www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580432.htm
-
FDA Drugs – Biosimilar Product Information: FDA-Approved Biosimilar Products; FDA website,www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580432.htm
-
-
-
-
18
-
-
85148919299
-
-
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp
-
EMA Human Medicines – Find Medicine: European Public Assessment Reports – Browse byType; EMA website, http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp
-
-
-
-
19
-
-
85148922025
-
-
www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/default.htm
-
FDA Vaccines, Blood & Biologics: Cellular and Gene Therapy Products; FDA website, www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/default.htm
-
-
-
-
20
-
-
85148919564
-
-
www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000294.jsp
-
EMA Human Regulatory: Advanced Therapies; EMA website, www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000294.jsp
-
-
-
-
21
-
-
85148919380
-
-
www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
-
FDA Vaccines, Blood & Biologics: Cellular and Gene Therapy Products – Regenerative MedicineAdvanced Therapy Designation; FDA website, www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm
-
-
-
-
22
-
-
85148925477
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf
-
FDA Vaccines, Blood Products & Biologics: Approved Products – Provenge (Sipuleucel) –FDA Package Insert and Patient Information (2010); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM210031.pdf
-
-
-
-
23
-
-
85148924438
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002771/WC500201082.pdf
-
EMA European Public Assessment Report: Imlygic (Talimogene Laherparepvec) (2015);www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002771/WC500201082.pdf
-
-
-
-
24
-
-
85148916867
-
-
www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566166.pdf
-
Kymriah (Tisagenlecleucel) FDA Briefing Document Oncologic Drugs AdvisoryCommittee Meeting July 12, 2017; www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566166.pdf
-
-
-
-
25
-
-
85148918521
-
-
www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000301.jsp
-
EMA Advanced Therapy Classification: Summaries of Scientific Recommendations onClassification of Advanced Therapy Medicinal Products; EMA website, www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000301.jsp
-
-
-
-
26
-
-
85148922053
-
-
www.ema.europa.eu/docs/en_GB/document_library/Report/2018/05/WC500248828.pdf
-
EMA PRIME – Priority Medicines: A Two-year Overview, EMA/242980/2018; EMA website,www.ema.europa.eu/docs/en_GB/document_library/Report/2018/05/WC500248828.pdf
-
-
-
-
27
-
-
85148924784
-
-
www.fda.gov/NewsEvents/Speeches/ucm609579.htm
-
FDA – Speeches by FDA Officials: Remarks by Commissioner Gottlieb to the Alliance forRegenerative Medicine’s Annual Board Meeting (May 22, 2018); www.fda.gov/NewsEvents/Speeches/ucm609579.htm
-
-
-
-
28
-
-
85148919927
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=312
-
FDA CFR Code of Federal Regulations: Title 21 Part 312 Investigational New Drug Application;FDA website, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=312
-
-
-
-
29
-
-
85148921953
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=314
-
FDA Code of Federal Regulations: Title 21 Part 314 Applications for FDA Approval to Marketa New Drug; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=314
-
-
-
-
30
-
-
85148915848
-
-
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM579751.pdf
-
FDA Draft Guidance for Industry: Determining Whether to Submit an ANDAor a 505(b)(2) Application (October 2017); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM579751.pdf
-
-
-
-
31
-
-
85148921146
-
-
www.fda.gov/Drugs/DrugSafety/ucm220037.htm
-
FDA Drug Safety and Availability: Generic Enoxaparin Questions and Answers; www.fda.gov/Drugs/DrugSafety/ucm220037.htm
-
-
-
-
32
-
-
85148925882
-
-
www.ecfr.gov/cgi-bin/text-idx?SID=e9030f5ed5963eb10787bbc88fcd8d28&mc=true&tpl=/ecfrbrowse/Title21/21cfrv7_02.tpl#0
-
FDA Code of Federal Regulations: Title 21 Part 600–680 Subchapter F – Biologics; eCFRwebsite, www.ecfr.gov/cgi-bin/text-idx?SID=e9030f5ed5963eb10787bbc88fcd8d28&mc=true&tpl=/ecfrbrowse/Title21/21cfrv7_02.tpl#0
-
-
-
-
33
-
-
85148924254
-
-
uscode.house.gov/view.xhtml?req=(title:42%20section:262%20edition:prelim)
-
United States Congress 262: Regulation of Biological Products (June 2018); uscode.house.gov/view.xhtml?req=(title:42%20section:262%20edition:prelim)
-
-
-
-
34
-
-
85148922750
-
-
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273001.pdf
-
FDA Guidance For Industry Biosimilars: Questions and Answers Regarding Implementationof the Biologics Price Competition and Innovation Act of 2009 (April 2015); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273001.pdf
-
-
-
-
35
-
-
85148920224
-
-
www.pharmamedtechbi.com/~/media/Supporting%20Documents/The%20Pink%20Sheet/74/17/PhRMAqualityconsiderations.pdf
-
Pharmaceutical Research and Manufacturers of America (PhRMA), April 16, 2012, WrittenResponse to Docket No. FDA-2011-D-0602: Draft Guidance for Industry on QualityConsiderations in Demonstrating Biosimilarity to a Reference Protein Product; 77 Fed. Reg.8884 (Feb. 15, 2012); www.pharmamedtechbi.com/~/media/Supporting%20Documents/The%20Pink%20Sheet/74/17/PhRMAqualityconsiderations.pdf
-
-
-
-
36
-
-
85148920179
-
-
www.accessdata.fda.gov/scripts/cder/daf/index.cfm
-
FDA Drug Databases: Drugs@FDA – FDA Approved Drug Products; FDA website, www.accessdata.fda.gov/scripts/cder/daf/index.cfm
-
-
-
-
37
-
-
85148926527
-
-
www.accessdata.fda.gov/scripts/cder/daf/index.cfm
-
FDA Drug Databases: Drugs@FDA – FDA Approved Drug Products – Mylotarg (GemtuzumabOxogamicin) – Market Approval Letter (2017); www.accessdata.fda.gov/scripts/cder/daf/index.cfm
-
-
-
-
38
-
-
85148919156
-
-
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM490264.pdf
-
FDA Guidance for Industry (Draft): Implementation of the “Deemed to be a License” Provisionof the Biologics Price Competition and Innovation Act of 2009 (March 2016); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM490264.pdf
-
-
-
-
39
-
-
85148926585
-
-
www.federalregister.gov/articles/2012/05/03/2012-10649/amendments-to-sterility-test-requirements-for-biological-products
-
US Federal Register Vol 77 Docket No. FDA-2012-N-0080 Amendments to SterilityTest Requirements For Biological Products, Effective June 04, 2012, pp 26162–26175 (May 03, 2012); www.federalregister.gov/articles/2012/05/03/2012-10649/amendments-to-sterility-test-requirements-for-biological-products
-
-
-
-
40
-
-
85148927680
-
-
www.federalregister.gov/documents/2015/07/02/2015-16366/revocation-of-general-safety-test-regulations-that-are-duplicative-of-requirements-in-biologics
-
US Federal Register Vol 80 Docket No. FDA-2015-N-1110 Revocation of General SafetyRegulations That Are Duplicative of Requirements in Biologics License Applications,Effective August 03, 2015, pp 37971–37974 (July 02, 2015); www.federalregister.gov/documents/2015/07/02/2015-16366/revocation-of-general-safety-test-regulations-that-are-duplicative-of-requirements-in-biologics
-
-
-
-
41
-
-
85148919773
-
-
www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol7/pdf/CFR-2011-title21-vol7-part610.pdf
-
FDA CFR Code of Federal Regulations: Title 21, Part 610.14 Identity; www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol7/pdf/CFR-2011-title21-vol7-part610.pdf
-
-
-
-
42
-
-
85148927090
-
-
www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761065Orig1s000AdminCorres.pdf
-
FDA Drug Databases: Drugs@FDA – FDA Approved Drug Products – Trogarzo (Ibalizumab-uiyk)– Approval History, Letters, Reviews and Related Documents – Administrative andCorrespondence Documents – Meeting Minutes Mid-Cycle Communication (August 18,2017); www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761065Orig1s000AdminCorres.pdf
-
-
-
-
43
-
-
85148922871
-
-
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM603271.pdf
-
FDA Celltrion Establishment Inspection Report (June 2017); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM603271.pdf
-
-
-
-
44
-
-
85148922213
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=610.2
-
FDA Code of Federal Regulations Title 21 Food and Drugs – Part 610.2 Request For Samplesand Protocols, Official Release; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=610.2
-
-
-
-
45
-
-
85148922822
-
-
www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm062928.htm
-
FDA Vaccines, Blood & Biologics: Influenza Virus Vaccine Composition and Lot Release; FDAwebsite, www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm062928.htm
-
-
-
-
46
-
-
85148916740
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581750.pdf
-
FDA Vaccines, Blood & Biologics: Approved Products – Shingrix (Zoster VaccineRecombinant, Adjuvanted) – Approval Letter (October 20, 2017); www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581750.pdf
-
-
-
-
47
-
-
85148923183
-
-
www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm431446.htm
-
FDA Vaccines, Blood & Biologics: Approved Products – Bexsero (Meningococcal GroupB Vaccine) – Approval Letter (January 23, 2015); www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm431446.htm
-
-
-
-
48
-
-
85148921430
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM562369.pdf
-
FDA Vaccines, Blood & Biologics: Approved Products – Fibryna (HumanFibrinogen) – Approval Letter (June 07, 2017); www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM562369.pdf
-
-
-
-
49
-
-
85148925670
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM584820.pdf
-
FDA Vaccines, Blood & Biologics: Approved Products – Heplisav-B (Hepatitis B Vaccine,Recombinant, Adjuvanted) – Approval Letter (November 09, 2017); www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM584820.pdf
-
-
-
-
50
-
-
85148920293
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM561415.pdf
-
FDA Vaccines, Blood & Biologics: Approved Products – Rebinyn (Coagulation Factor IX,Recombinant, GlycoPEGylated – Approval Letter (May 31, 2017); www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM561415.pdf
-
-
-
-
51
-
-
85148924062
-
-
www.gpo.gov/fdsys/pkg/FR-1995-12-08/pdf/95-29960.pdf
-
US Federal Register Vol 60 Docket No. FDA-95 N–0371 Interim Definition and Eliminationof Lot-by-Lot Release for Well-Characterized Therapeutic Recombinant DNA-Derived andMonoclonal Antibody Biotechnology Products (December 08, 1995); www.gpo.gov/fdsys/pkg/FR-1995-12-08/pdf/95-29960.pdf
-
-
-
-
52
-
-
85148927205
-
-
www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol7/pdf/CFR-2011-title21-vol7-part601.pdf
-
Code of Federal Regulations Title 21 Food and Drugs – Part 601.2 Applications for BiologicsLicenses; www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol7/pdf/CFR-2011-title21-vol7-part601.pdf
-
-
-
-
53
-
-
85148924566
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761075Orig1s000Ltr.pdf
-
FDA Drugs Database: Drugs@FDA – FDA Approved Drug Products – Fulphila (Pegfilgrastim-jmdb)– Approval Letter (June 04, 2018); www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761075Orig1s000Ltr.pdf
-
-
-
-
54
-
-
85148924576
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761068Orig1s000ltr.pdf
-
FDA Drugs Database: Drugs@FDA – FDA Approved Drug Products – Crysvita (Burosumab-twza)– Approval Letter (April 17, 2018); www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761068Orig1s000ltr.pdf
-
-
-
-
55
-
-
85148924460
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM469670.pdf
-
FDA Vaccines, Blood & Biologics: Approved Products – Imlygic (TalimogeneLaherparepvec) – Approval Letter (October 27, 2015); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM469670.pdf
-
-
-
-
56
-
-
85148923048
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM589690.pdf
-
FDA Vaccines, Blood & Biologics: Approved Products – Luxturna (Voretigene Neparvovecrzyl)– Approval Letter (December 19, 2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM589690.pdf
-
-
-
-
57
-
-
85148920996
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM574106.pdf
-
FDA Vaccines, Blood & Biologics: Approved Products – Kymriah (Tisagenlecleucel) –Approval Letter (August 30, 2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM574106.pdf
-
-
-
-
58
-
-
85148917136
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM581259.pdf
-
FDA Vaccines, Blood & Biologics: Approved Products – Yescarta (Axicabtagene Ciloleucel) –Approval Letter (October 18, 2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM581259.pdf
-
-
-
-
59
-
-
85148918269
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=600.14
-
Code of Federal Regulations Title 21 Food and Drugs – Part 600.14 Reporting of BiologicalProduct Deviations By Licensed Manufacturers; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=600.14
-
-
-
-
60
-
-
85148923164
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=314.81
-
Code of Federal Regulations Title 21 Food and Drugs – Part 314.81 Other PostmarketingReports; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=314.81
-
-
-
-
61
-
-
85148921557
-
-
www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176734.htm
-
FDA Inspections, Compliance, Enforcement, and Criminal Investigations – RegulatoryProcedures Manual: Injunctions; FDA website, www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176734.htm
-
-
-
-
62
-
-
85148927023
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=601.6
-
Code of Federal Regulations Title 21 Food and Drugs – Part 601.6 Suspension of License;www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=601.6
-
-
-
-
63
-
-
85148922740
-
-
www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm
-
FDA Frequently Asked Questions About Therapeutic Biological Products; FDA website,www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm
-
-
-
-
64
-
-
85148924692
-
-
www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133463.htm
-
FDA Transfer of Therapeutic Products to the Center for Drug Evaluation and Research; FDAwebsite, www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133463.htm
-
-
-
-
65
-
-
85148927314
-
-
www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm385288.htm
-
FDA Warning Letter Issued to Amgen (January 27, 2014); FDA Warning Letters website,www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm385288.htm
-
-
-
-
66
-
-
85148924933
-
-
www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm
-
FDA Search for FDA Guidance Documents: Combination Products Guidance Documents;FDA website, www.fda.gov/RegulatoryInformation/Guidances/ucm122047.htm
-
-
-
-
67
-
-
85148918234
-
-
ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf
-
EC Directive 2001/83/EC of the European Parliament and Council, Concerning CommunityCode Relating to Medicinal Products for Human Use; ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf
-
-
-
-
68
-
-
85148918876
-
-
ec.europa.eu/health/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf
-
EC Directive 2001/20/EC of the European Parliament and Council, Concerning Implementationof Good Clinical Practice in the Conduct of Clinical Trials on Medicinal Products for HumanUse; ec.europa.eu/health/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf
-
-
-
-
69
-
-
85148915624
-
-
ec.europa.eu/health/files/eudralex/vol-10/2010_c82_01/2010_c82_01_en.pdf
-
EC Detailed Guidance for the Request of Authorisation of a Clinical Trial on a MedicinalProduct for Human Use to the Competent Authorities, Notification of Substantial Amendmentsand Declaration of the End of the Trial (March 2010); ec.europa.eu/health/files/eudralex/vol-10/2010_c82_01/2010_c82_01_en.pdf
-
-
-
-
70
-
-
85148923887
-
-
http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2010_03_VHP_Guidance_v2.pdf
-
Heads of Medicines Agencies: Clinical Trials Facilitation Group – GuidanceDocument for a Voluntary Harmonisation Procedure (VHP) For the Assessmentof Multinational Clinical Trial Applications, Version 2 (March 2010); http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2010_03_VHP_Guidance_v2.pdf
-
-
-
-
71
-
-
85148921102
-
-
ec.europa.eu/health/human-use/clinical-trials/regulation_en
-
EC Medicinal Products – Clinical Trials: Regulation 536/2014; ec.europa.eu/health/human-use/clinical-trials/regulation_en
-
-
-
-
72
-
-
85148919228
-
-
ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2004_726/reg_2004_726_en.pdf
-
EC Medicinal Products – Authorisation and Supervision of Medicinal Products: Regulation726/2004; ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2004_726/reg_2004_726_en.pdf
-
-
-
-
73
-
-
85148926331
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761068Orig1s000ltr.pdf
-
FDA Drugs Database: Search Drugs@FDA – FDA Approved Drug Products – Crysvita(Burosumab-twza) – Approval Letter (April 17, 2018); www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761068Orig1s000ltr.pdf
-
-
-
-
74
-
-
85148922360
-
-
https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm177457.htm
-
FDA Vaccines, Blood and Biologics – Approved Products: Afluria (Influenze Virus Vaccine) –Approval Letter (September 28, 2007); wayback.archive-it.org/7993/20170723030201/https://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm177457.htm
-
-
-
-
75
-
-
85148922620
-
-
www.ICH.org/about/members-observers.html
-
ICH Members and Observers (November 2018); www.ICH.org/about/members-observers.html
-
-
-
-
76
-
-
85148916651
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761065Orig1s000ltr.pdf
-
FDA Drugs Database: Search Drugs@FDA – FDA Approved Drug Products – Trogarzo(Ibalizumab-uiyk) – Approval Letter (March 6, 2018); www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761065Orig1s000ltr.pdf
-
-
-
-
77
-
-
85148921008
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002150/WC500154066.pdf
-
EMA European Public Assessment Report (EPAR): Grastofil (Recombinant Human Filgrastim)Biosimilar (July 2013); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002150/WC500154066.pdf
-
-
-
-
78
-
-
85148921787
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761074Orig1s000ltr.pdf
-
FDA Drugs Database: Search Drugs@FDA – FDA Approved Drug Products – Ogivri(Trastuzumab-dkst) Biosimilar – Approval Letter (December 1, 2017); www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761074Orig1s000ltr.pdf
-
-
-
-
79
-
-
85148916927
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf
-
EMA European Public Assessment Report (EPAR): Inflectra (Infliximab) Biosimilar (June2013); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf
-
-
-
-
80
-
-
85148926923
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125544Orig1s000ltr.pdf
-
FDA Drugs Database: Search Drugs@FDA – FDA Approved Drug Products – Inflectra(Infliximab-dyyb) Biosimilar – Approval Letter (April 5, 2016); www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125544Orig1s000ltr.pdf
-
-
-
-
81
-
-
85148923761
-
-
www.samsungbiologics.com/front/eng/main.do
-
Samsung BioLogics website: www.samsungbiologics.com/front/eng/main.do
-
-
-
-
82
-
-
85148921156
-
-
www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm
-
FDA About the Center for Biologics Evaluation and Research: What Are “Biologics –Questions and Answers; FDA website, www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm133077.htm
-
-
-
-
83
-
-
85148917619
-
-
www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm
-
FDA Drugs: Frequently Asked Questions About Therapeutic Biological Products; FDA website,www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm113522.htm
-
-
-
-
84
-
-
85148921163
-
-
www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf
-
EMA Biosimilars in the EU: Information Guide for Healthcare Workers (April 2017); www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf
-
-
-
-
85
-
-
85148925962
-
-
ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/2018_annex2_en.pdf
-
EU EudraLex The Rules Governing Medicinal Products in the European Union, Volume4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human andVeterinary Use, Annex 2 Manufacture of Biological Medicinal Substances and Productsfor Human Use (June 2018); ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/pdfs-en/2018_annex2_en.pdf
-
-
-
-
86
-
-
85148917260
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf
-
ICH Q6A Specifications: Test Procedures and Acceptance Criteria For New Drug Substancesand New Drug Products: Chemical Substances (October 1999); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf
-
-
-
-
87
-
-
85148922047
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
ICH Q6B Specifications: Test Procedures and Acceptance Criteria For Biotechnological/Biological Products (March 1999); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
-
-
-
88
-
-
85148921847
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf
-
ICH Q1A(R2) Stability Testing of New Drug Substances and New Drug Products (February2003); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1A_R2/Step4/Q1A_R2__Guideline.pdf
-
-
-
-
89
-
-
85148920337
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5C/Step4/Q5C_Guideline.pdf
-
ICH Q5C Stability Testing of Biotechnological/Biological Products (November 1995);ICH website, www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5C/Step4/Q5C_Guideline.pdf
-
-
-
-
90
-
-
85148924435
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5A_R1/Step4/Q5A_R1__Guideline.pdf
-
ICH Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived From Cell Linesof Human or Animal Origin (September 1999); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5A_R1/Step4/Q5A_R1__Guideline.pdf
-
-
-
-
91
-
-
85148918902
-
-
www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm506040.htm
-
FDA Generic Drugs: What is the Approval Process for Generic Drugs; FDA website, www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm506040.htm
-
-
-
-
92
-
-
85148921537
-
-
www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-ice/documents/webcontent/ucm074367.pdf
-
FDA CPG Sec. 420.100 Adulteration of Drugs Under Section 501(b) and 501(c) of the Act(May 1992); www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-ice/documents/webcontent/ucm074367.pdf
-
-
-
-
93
-
-
85148925793
-
-
www.edqm.eu/en/european-pharmacopoeia-background-50.html
-
Council of Europe: European Pharmacopeia (Ph.Eur.) – Background & Mission; EDQMwebsite, www.edqm.eu/en/european-pharmacopoeia-background-50.html
-
-
-
-
94
-
-
85148922802
-
-
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM602973.pdf
-
FDA Letter to USP: Drug Product Monographs for Biological Products (March 28,2018); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM602973.pdf
-
-
-
-
95
-
-
85148922045
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf
-
ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in TheirManufacturing Process (November 2004); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf
-
-
-
-
96
-
-
85148920547
-
-
www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074181.htm
-
FDA Biotechnology Inspection Guide (November 1991); www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074181.htm
-
-
-
-
97
-
-
79953861167
-
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
-
Schiestl, M., Stangler, T., et al., Acceptable Changes in Quality Attributes of Glycosylated Biopharmaceuticals; Nat Biotechol(2011)29: 310–312
-
(2011)
Nat Biotechol
, vol.29
, pp. 310-312
-
-
Schiestl, M.1
Stangler, T.2
-
98
-
-
85148926340
-
-
www.fda.gov/downloads/drugs/guidances/ucm291134.pdf
-
FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of aTherapeutic Protein Product to a Reference Product (April 2015); www.fda.gov/downloads/drugs/guidances/ucm291134.pdf
-
-
-
-
99
-
-
84958046376
-
-
Deller, M.C., Kong, L, and RuppB., Protein Stability: A Crystallographer’s Perspective; ActaCryst. (2016)F72: 72–95; www.ncbi.nlm.nih.gov/pmc/articles/PMC4741188/
-
(2016)
Protein Stability: A Crystallographer’s Perspective; Actacryst
, vol.72
, pp. 72-95
-
-
Deller, M.C.1
Kong, L.2
Rupp, B.3
-
100
-
-
85148916619
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/UCM202439.pdf
-
FDA Guidance for Industry: Characterization and Qualification of Cell Substrates and OtherBiological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications(February 2010); www.fda.gov/downloads/BiologicsBloodVaccines/UCM202439.pdf
-
-
-
-
101
-
-
85148916827
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM564952.pdf
-
FDA Guidance for Industry: Considerations for the Design of Early-Phase ClinicalTrials of Cellular and Gene Therapy Products (June 2015); www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM564952.pdf
-
-
-
-
102
-
-
85148926053
-
-
www.fda.gov/BiologicsBloodVaccines/ScienceResearch/BiologicsResearchAreas/ucm127312.htm
-
FDA Vaccines, Blood & Biologics: Biologics Research Projects – Evaluation of Safety andPotency of Viral Vaccines Based on Analysis of Molecular Consistency; FDA website, www.fda.gov/BiologicsBloodVaccines/ScienceResearch/BiologicsResearchAreas/ucm127312.htm
-
-
-
-
103
-
-
85148917165
-
-
www.ema.europa.eu/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf
-
EMA Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene TherapyMedicinal Products (March 2018); www.ema.europa.eu/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf
-
-
-
-
104
-
-
85148917541
-
-
www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf
-
EMA/EC: Biosimilars in th EU – Information Guide for Healthcare Professionals (2017);www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf
-
-
-
-
105
-
-
33747451721
-
Current and future issues in the manufacturing and development of monoclonal antibodies
-
Aug 7
-
Kozlowski, S. and Swann, P., Current and Future Issues in the Manufacturing and Development of Monoclonal Antibodies; Adv. Drug Deliv Rev. (2006Aug 7)58(5–6): 707–722
-
(2006)
Adv. Drug Deliv Rev
, vol.58
, Issue.5-6
, pp. 707-722
-
-
Kozlowski, S.1
Swann, P.2
-
106
-
-
85148927728
-
-
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/06/WC500228861.pdf
-
EMA Guideline on Immunogenicity Assessment of Therapeutic Proteins (May 2017);www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/06/WC500228861.pdf
-
-
-
-
107
-
-
85148918367
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002145/WC500135476.pdf
-
EMA European Public Assessment Report (EPAR): Glybera (Alipogene Tiparvovec) (July2012); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002145/WC500135476.pdf
-
-
-
-
108
-
-
85148923928
-
-
www.fda.gov/NewsEvents/Speeches/ucm609579.htm
-
FDA – Speeches by FDA Officials: Remarks by Commissioner Gottlieb to the Alliance forRegenerative Medicine’s Annual Board Meeting (May 22, 2018); www.fda.gov/NewsEvents/Speeches/ucm609579.htm
-
-
-
-
109
-
-
85148915754
-
-
www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm
-
FDA Drugs – Therapeutic Biological Applications (BLA): Biosimilars –Biosimilar and Interchangeable Products; FDA website, www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm
-
-
-
-
110
-
-
85148915581
-
-
ec.europa.eu/growth/content/information-patients-what-i-need-know-about-biosimilarmedicines-0_en
-
EMA/EC What I Need to Know About Biosimilar Meedicines – Information for Patients (2017);ec.europa.eu/growth/content/information-patients-what-i-need-know-about-biosimilarmedicines-0_en
-
-
-
-
111
-
-
85148927105
-
-
www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html
-
Health Canada Biologics, Radiopharmaceuticals and Generic Therapies: Fact Sheet -Biosimilars; HC website, www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html
-
-
-
-
112
-
-
85148923412
-
-
www.who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf?ua=1
-
World Health Organization Biologicals – Similar Biotherapeutic Products: Annex 2 –Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs) – Technical ReportSeries No. 977 (2013); www.who.int/biologicals/publications/trs/areas/biological_therapeutics/TRS_977_Annex_2.pdf?ua=1
-
-
-
-
113
-
-
85148922585
-
-
www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580429.htm
-
FDA Drugs – Therapeutic Biological Applications (BLA): Biosimilars – BiosimilarDevelopment, Review and Approval; FDA website, www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580429.htm
-
-
-
-
114
-
-
85148920294
-
-
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
-
FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of aTherapeutic Protein Product to a Reference Product (April 2015); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291134.pdf
-
-
-
-
115
-
-
85148921374
-
-
www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125166.pdf
-
EMA Procedural Advice for Users of the Centralised Procedure for Similar BiologicalMedicinal Products Applications (May 2017); www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125166.pdf
-
-
-
-
116
-
-
85148919377
-
-
www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
-
World Health Organization Expert Committee on Biological Standardization: Guidelines onEvaluation of Similar Biotherapeutic Products (SBPs) (2009); www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
-
-
-
-
117
-
-
85148917348
-
-
www.fda.gov/Drugs/DevelopmentApprovalProcess/H o w D r u g s a r e D e v e l o p e d a n d A p p r o v e d / A p p r o v a l A p p l i c a t i o n s /TherapeuticBiologicApplications/Biosimilars/ucm580419.htm#biosimilar
-
FDA Drugs -Therapeutic Biologic Applications (BLA): Biosimilar and InterchangeableProducts; FDA website, www.fda.gov/Drugs/DevelopmentApprovalProcess/H o w D r u g s a r e D e v e l o p e d a n d A p p r o v e d / A p p r o v a l A p p l i c a t i o n s /TherapeuticBiologicApplications/Biosimilars/ucm580419.htm#biosimilar
-
-
-
-
118
-
-
85148919074
-
-
www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf
-
EMA/EC Biosimilars in the EU: Information guide for healthcare professionals (2017); www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2017/05/WC500226648.pdf
-
-
-
-
119
-
-
85148919532
-
-
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf
-
FDA Draft Guidance for Industry: Considerations in Demonstrating Interchangeabilitywith a Reference Product (January 2017); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM537135.pdf
-
-
-
-
120
-
-
85148917531
-
-
www.who.int/medicines/services/inn/en/
-
WHO Essential Medicines and Health Products: International Nonproprietary Names; WHOwebsite, www.who.int/medicines/services/inn/en/
-
-
-
-
121
-
-
85148917600
-
-
www.fda.gov/downloads/drugs/guidances/ucm459987.pdf
-
FDA Guidance for Industry: Nonproprietary Naming of Biological Products (January 2017);www.fda.gov/downloads/drugs/guidances/ucm459987.pdf
-
-
-
-
122
-
-
85148917196
-
-
www.who.int/medicines/services/inn/inn_bio_bq/en/
-
WHO Essential Medicines and Health Products: Biological Qualifier; WHO website, www.who.int/medicines/services/inn/inn_bio_bq/en/
-
-
-
-
123
-
-
85148921209
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf
-
ICH Q10 Pharmaceutical Quality System (June 2008); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf
-
-
-
-
124
-
-
85148917486
-
-
www.fda.gov/downloads/drugs/guidances/ucm353925.pdf
-
FDA Guidance For Industry – Contract Manufacturing Arrangements for Drugs: QualityAgreements (November 2016); www.fda.gov/downloads/drugs/guidances/ucm353925.pdf
-
-
-
-
125
-
-
85148922163
-
-
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM569851.pdf
-
FDA Drugs: Form 483 – Biocon Limited May 25, 2017 – June 3, 2017; www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM569851.pdf
-
-
-
-
126
-
-
85148915770
-
-
www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm594395.htm
-
FDA Inspections, Compliance, Enforcement, and Criminal Investigations : WarningLetters – Celltrion Inc. January 26,2 018 – Warning Letter 320–18-28; www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm594395.htm
-
-
-
-
127
-
-
85148916004
-
-
cdn.ymaws.com/www.casss.org/resource/resmgr/imported/AMab_Case_Study_Version_2-1.pdf
-
CMC Biotech Working Group – A-Mab: A Case Study in Bioprocess Development (October30, 2009); CASSS website, cdn.ymaws.com/www.casss.org/resource/resmgr/imported/AMab_Case_Study_Version_2-1.pdf
-
-
-
-
128
-
-
85148921004
-
-
www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/cellulartissueandgenetherapiesadvisorycommittee/ucm579300.pdf
-
FDA Cellular, Tissue, and Gene Therapies Advisory Committee Meeting: Sparks TherapyBriefing Document (October 12, 2017) – Luxturna (Voretigene neparvovec); www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/bloodvaccinesandotherbiologics/cellulartissueandgenetherapiesadvisorycommittee/ucm579300.pdf
-
-
-
-
129
-
-
85148917965
-
-
www.fda.gov/ForConsumers/ConsumerUpdates/ucm143980.htm
-
FDA Consumer Updates: Creating Human Drugs From Genetically Engineered Animals;FDA website, www.fda.gov/ForConsumers/ConsumerUpdates/ucm143980.htm
-
-
-
-
130
-
-
85148926981
-
-
www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm573960.htm
-
FDA Vaccines, Blood & Biologics: Cellular & Gene Therapy Products – What is GeneTherapy; FDA website, www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm573960.htm
-
-
-
-
131
-
-
85148922308
-
-
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/06/WC500228861.pdf
-
EMA Guideline on Immunogenicity Assessment of Therapeutic Proteins (May 2017);www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2017/06/WC500228861.pdf
-
-
-
-
132
-
-
85148916683
-
-
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003154.pdf
-
EMA Guideline on the Quality of Biologically Active Substances Produced by StableTransgene Expression in Higher Plants (July 2008); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003154.pdf
-
-
-
-
133
-
-
85148925520
-
-
www.ema.europa.eu/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf
-
EMA Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene TherapyMedicinal Products (March 2018); www.ema.europa.eu/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf
-
-
-
-
134
-
-
85148916420
-
-
www.dcvmn.org/IMG/pdf/a-vax-applying-qbd-to-vaccines_2012.pdf
-
A-VAX: Applying Quality By Design to Vaccines – CMC-Vaccines Working Group (May2012); www.dcvmn.org/IMG/pdf/a-vax-applying-qbd-to-vaccines_2012.pdf
-
-
-
-
135
-
-
85148919630
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf
-
ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities andBiotechnological/Biological Entities) (May 2012); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf
-
-
-
-
136
-
-
85148919026
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002547/WC500141004.pdf
-
EMA European Public Assessment Report (EPAR): Perjeta (Pertuzumab) (December 2012);www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002547/WC500141004.pdf
-
-
-
-
137
-
-
84995790815
-
Determination of critical quality attributes for monoclonal antibodies using quality by design principles
-
Alt, N., Zhang, T.Y. et.al., Determination of Critical Quality Attributes For Monoclonal Antibodies Using Quality by Design Principles, Biologicals(2016)44: 291–305
-
(2016)
Biologicals
, vol.44
, pp. 291-305
-
-
Alt, N.1
Zhang, T.Y.2
-
138
-
-
84979255600
-
Process characterization and design space definition
-
Hakemeyer, C., McKnight, N., et.al., Process Characterization and Design Space Definition,Biologicals(2016)44: 306–318
-
(2016)
Biologicals
, vol.44
, pp. 306-318
-
-
Hakemeyer, C.1
McKnight, N.2
-
139
-
-
85148916169
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001120/WC500093529.pdf
-
EMA European Public Assessment Report (EPAR): Prolia (Denosumab) (March 2010);www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001120/WC500093529.pdf
-
-
-
-
140
-
-
85148916366
-
-
www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm358781.htm
-
FDA Vaccines, Blood & Biologics: Licensed Products with Supporting Data –Rixubis (Coagulation Factor IX, Recombinant) – Approval History, Letters,Reviews, and Related Documents – Final CMC Review (April 2013); www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm358781.htm
-
-
-
-
141
-
-
84995803071
-
Establishing a control system using qbd principles
-
Kepert, J.F., Cromwell, M., et. al., Establishing a Control System Using QbD Principles,Biologicals(2016)44: 319–331
-
(2016)
Biologicals
, vol.44
, pp. 319-331
-
-
Kepert, J.F.1
Cromwell, M.2
-
142
-
-
85148918544
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125486Orig1s000ltr.pdf
-
FDA Drug Databases: Drugs@FDA – FDA Approved Drug Products – Gazyva (Obinutuzumab)(November 2013); www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125486Orig1s000ltr.pdf
-
-
-
-
143
-
-
85148923202
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002799/WC500171596.pdf
-
EMA European Public Assessment Report (EPAR): Gazyvaro (Obinutuzumab) (May 2014);www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002799/WC500171596.pdf
-
-
-
-
144
-
-
85148927213
-
-
www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm
-
FDA CDER Manual of Policies & Procedures (MAPP): 5016.1 Applying ICH Q8(R2), Q9and Q10 Principles to CMC Review (May 2016); www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm
-
-
-
-
145
-
-
85148926500
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004209/WC500232107.pdf
-
EMA European Public Assessment Report (EPAR): Oxervate (Cenegermin) (May 2017) ;www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004209/WC500232107.pdf
-
-
-
-
146
-
-
85148920265
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004065/WC500229800.pdf
-
EMA European Public Assessment Report (EPAR): Brineura (Cerliponase Alfa) (April 2017); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004065/WC500229800.pdf
-
-
-
-
147
-
-
85148922129
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004406/WC500244745.pdf
-
EMA European Public Assessment Report (EPAR): Hemlibra (Emicizumab) (January 2018); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004406/WC500244745.pdf
-
-
-
-
148
-
-
85148923762
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004336/WC500246552.pdf
-
EMA European Public Assessment Report (EPAR): Shingrix (Herpes Zoster Vaccine,Recombinant, Adjunvanted) (January 2018); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004336/WC500246552.pdf
-
-
-
-
149
-
-
85148915759
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003855/WC500204191.pdf
-
EMA European Public Assessment Report (EPAR): Coagadex (Human Coagulation Factor X)(January 2016) ; www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003855/WC500204191.pdf
-
-
-
-
150
-
-
85148921328
-
-
www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm589507.htm
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Luxturna (Voretigene Neparvovec-rzyl) – Approval History, Letters, Reviews, and RelatedDocuments – CMC Review (December 2017); www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm589507.htm
-
-
-
-
151
-
-
85148922804
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002801/WC500212588.pdf
-
EMA European Public Assessment Report (EPAR): Zalmoxis (Allogeneic T-Cells GeneticallyModified with a Retroviral Vector Encoding for a Truncated Form of the Human Low AffinityNerve Growth Factor Receptor (ΔLNGFR) and the Herpes Simplex I Virus Thymidine Kinase(HSV-TK Mut2)) (June 2016); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002801/WC500212588.pdf
-
-
-
-
152
-
-
85148916397
-
-
www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/2013/09/WC500149845.pdf
-
EMA European Public Assessment Report (EPAR) – Withdrawn Applications: Ixinity(Recombinant Coagulation Factor IX) (September 2012) ; www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_assessment_report/2013/09/WC500149845.pdf
-
-
-
-
153
-
-
85148925407
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312
-
FDA Code of Federal Regulations (CFR) Title 21 Part 312.23 – General Principles ofthe IND Submission; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312
-
-
-
-
154
-
-
85148919260
-
-
www.fda.gov/downloads/drugs/guidances/ucm070273.pdf
-
FDA Guidance for Industry: CGMP for Phase 1 Investigational Drugs (2008); www.fda.gov/downloads/drugs/guidances/ucm070273.pdf
-
-
-
-
155
-
-
85148927768
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610795.pdf
-
FDA (Draft) Guidance Industry: Chemistry, Manufacturing, and Control (CMC) Informationfor Human Gene Therapy Investigational New Drug Applications (INDs) (July 2018); www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610795.pdf
-
-
-
-
156
-
-
85148915650
-
-
www.ema.europa.eu/documents/scientific-guideline/guideline-requirements-quality-documentation-concerningbiological-investigational-medicinal_en-0.pdf
-
EMA Guideline on the Requirements for Quality Documentation Concerning BiologicalInvestigational Medicinal Products in Clinical Trials (September 2018); www.ema.europa.eu/documents/scientific-guideline/guideline-requirements-quality-documentation-concerningbiological-investigational-medicinal_en-0.pdf
-
-
-
-
157
-
-
85148924558
-
-
ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf
-
European Commission – EudraLex the Rules Governing Medicinal Products in the EuropeanUnion, Volume 4, Good Manufacturing Practice: Guidelines on Good Manufacturing PracticeSpecific to Advanced Therapy Medicinal Products (November 2017); ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf
-
-
-
-
158
-
-
85148918547
-
-
Parenteral Drug Association (PDA) Technical Report No. 56 (Revised 2016): Application ofPhase-Appropriate Quality System and cGMP to the Development of Therapeutic ProteinDrug Substance (API or Biologic Active Substance); PDA website, www.PDA.org
-
Parenteral Drug Association (PDA) Technical Report No. 56 (Revised 2016): Application ofPhase-Appropriate Quality System and cGMP to the Development of Therapeutic ProteinDrug Substance (API or Biologic Active Substance); PDA website, www.PDA.org
-
-
-
-
159
-
-
85148916546
-
-
Parenteral Drug Association (PDA) Technical Report (2019): Cell-Based Therapy ControlStrategy; PDA website, www.PDA.org
-
Parenteral Drug Association (PDA) Technical Report (2019): Cell-Based Therapy ControlStrategy; PDA website, www.PDA.org
-
-
-
-
160
-
-
85148915429
-
-
EMA Workshop on the Guideline for First-in-Man Clinical Trials For Potentially High-RiskMedicinal Products: TGN 1412 – What Really Happened?; EMA website, www.ema.europa.eu/docs/en_GB/document_library/Presentation/2009/11/WC500010858.pdf
-
EMA Workshop on the Guideline for First-in-Man Clinical Trials For Potentially High-RiskMedicinal Products: TGN 1412 – What Really Happened?; EMA website, www.ema.europa.eu/docs/en_GB/document_library/Presentation/2009/11/WC500010858.pdf
-
-
-
-
161
-
-
85148927495
-
-
National Institutes of Health (NIH) News Release: NIH Suspends Operations in its ClinicalCenter Pharmaceutical Development Section (June 4, 2015) – FDA Form 483; NIH website,www.cc.nih.gov/phar/pdfs/483.pdf
-
National Institutes of Health (NIH) News Release: NIH Suspends Operations in its ClinicalCenter Pharmaceutical Development Section (June 4, 2015) – FDA Form 483; NIH website,www.cc.nih.gov/phar/pdfs/483.pdf
-
-
-
-
162
-
-
85148918274
-
-
National Institutes of Health (NIH) News Release: Statement on Review of NIH SterileProduction Facilities (April 19, 2016); NIH website, www.nih.gov/news-events/news-releases/statement-review-nih-sterile-production-facilities
-
National Institutes of Health (NIH) News Release: Statement on Review of NIH SterileProduction Facilities (April 19, 2016); NIH website, www.nih.gov/news-events/news-releases/statement-review-nih-sterile-production-facilities
-
-
-
-
163
-
-
85148921681
-
-
FDA Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics(May 2014); www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf
-
FDA Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics(May 2014); www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf
-
-
-
-
164
-
-
85148924820
-
-
FDA Drug Databases: Drugs@FDA – FDA Approved Drug Products – Darzalex(Daratumumab) – CDER Memorandum of Meeting Minutes – Breakthrough TherapyDaratumumab (Janssen Biotech) (July 31, 2013); www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761036Orig1s000Admincorres.pdf
-
FDA Drug Databases: Drugs@FDA – FDA Approved Drug Products – Darzalex(Daratumumab) – CDER Memorandum of Meeting Minutes – Breakthrough TherapyDaratumumab (Janssen Biotech) (July 31, 2013); www.accessdata.fda.gov/drugsatfda_docs/nda/2015/761036Orig1s000Admincorres.pdf
-
-
-
-
165
-
-
85148923952
-
-
EMA European Medicines Agency Guidance on Interactions in the Context of PRIME(May 2018); www.ema.europa.eu/docs/en_GB/document_library/Other/2018/05/WC500248826.pdf
-
EMA European Medicines Agency Guidance on Interactions in the Context of PRIME(May 2018); www.ema.europa.eu/docs/en_GB/document_library/Other/2018/05/WC500248826.pdf
-
-
-
-
166
-
-
85148923713
-
-
FDA Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to aReference Product (April 2015); www.fda.gov/downloads/drugs/guidances/ucm291128.pdf
-
FDA Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to aReference Product (April 2015); www.fda.gov/downloads/drugs/guidances/ucm291128.pdf
-
-
-
-
167
-
-
85148924469
-
-
FDA Speeches by FDA Officials: Remarks by Commissioner Gottlieb to the Alliance forRegenerative Medicine’s Annual Board Meeting (May 22, 2018); www.fda.gov/NewsEvents/Speeches/ucm608445.htm
-
FDA Speeches by FDA Officials: Remarks by Commissioner Gottlieb to the Alliance forRegenerative Medicine’s Annual Board Meeting (May 22, 2018); www.fda.gov/NewsEvents/Speeches/ucm608445.htm
-
-
-
-
168
-
-
85148921107
-
-
World Health Organization (WHO) Regulatory Risk Assessment in the Case of AdventitiousAgent Finding in a Marketed Vaccine: Scientific Principles to Consider (2013); www.who.int/biologicals/WHO_Risk_Assessment_1st_public_consultation_12_March_2013.pdf
-
World Health Organization (WHO) Regulatory Risk Assessment in the Case of AdventitiousAgent Finding in a Marketed Vaccine: Scientific Principles to Consider (2013); www.who.int/biologicals/WHO_Risk_Assessment_1st_public_consultation_12_March_2013.pdf
-
-
-
-
169
-
-
85148925377
-
-
ICH Q9 Quality Risk Management (November 2005); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf
-
ICH Q9 Quality Risk Management (November 2005); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf
-
-
-
-
170
-
-
85148920187
-
-
Centers for Disease Control and Prevention (CDC): Prion Diseases; CDC website, www.cdc.gov/prions/index.html
-
Centers for Disease Control and Prevention (CDC): Prion Diseases; CDC website, www.cdc.gov/prions/index.html
-
-
-
-
171
-
-
85148922545
-
-
Wickner, R.B., Yeast and Fungal Proteins, Cold Spring Harb Perspect Biol (2016); pdfs.semanticscholar.org/550a/dcd7c90ba03f47b05b6d108ed0eb879fa565.pdf
-
Wickner, R.B., Yeast and Fungal Proteins, Cold Spring Harb Perspect Biol (2016); pdfs.semanticscholar.org/550a/dcd7c90ba03f47b05b6d108ed0eb879fa565.pdf
-
-
-
-
172
-
-
85148924552
-
-
FDA Drugs: Celebrating a Milestone: FDA’s Approval of First Genetically-Engineered Product(2007);
-
FDA Drugs: Celebrating a Milestone: FDA’s Approval of First Genetically-Engineered Product(2007); www.fda.gov/downloads/aboutfda/history/productregulation/ucm593496.pdf
-
-
-
-
173
-
-
85148923001
-
-
FDA Drugs – Search Drugs@FDA: FDA Approved Drug Products – Eylea (Aflibercept):Approval History, Letters, Reviews and Related Documents – Administrative andCorrespondence Documents – Pre-BLA Meeting (September 27, 2010); www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387Orig1s000Admincorres.pdf
-
FDA Drugs – Search Drugs@FDA: FDA Approved Drug Products – Eylea (Aflibercept):Approval History, Letters, Reviews and Related Documents – Administrative andCorrespondence Documents – Pre-BLA Meeting (September 27, 2010); www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125387Orig1s000Admincorres.pdf
-
-
-
-
174
-
-
85148926045
-
-
FDA Drugs – Search Drugs@FDA: FDA Approved Drug Products – Adcetris (BrentuximabVedotin): Approval History, Letters, Reviews and Related Documents – Administrative andCorrespondence Documents – Pre-BLA Meeting (December 07, 2010); www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388Orig1s000AdminCorres.pdf
-
FDA Drugs – Search Drugs@FDA: FDA Approved Drug Products – Adcetris (BrentuximabVedotin): Approval History, Letters, Reviews and Related Documents – Administrative andCorrespondence Documents – Pre-BLA Meeting (December 07, 2010); www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388Orig1s000AdminCorres.pdf
-
-
-
-
175
-
-
85148922373
-
-
FDA Drugs – Search Drugs@FDA: FDA Approved Drug Products – Blincyto (Blinatumomab):Approval History, Letters, Reviews and Related Documents – Administrative andCorrespondence Documents – Pre-BLA Meeting (April 09, 2014); www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125557Orig1s000AdminCorres.pdf
-
FDA Drugs – Search Drugs@FDA: FDA Approved Drug Products – Blincyto (Blinatumomab):Approval History, Letters, Reviews and Related Documents – Administrative andCorrespondence Documents – Pre-BLA Meeting (April 09, 2014); www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125557Orig1s000AdminCorres.pdf
-
-
-
-
176
-
-
85148921108
-
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with SupportingDocuments – Kymriah (Tisagenlecleucel) – Package Insert (2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM573941.pdf
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with SupportingDocuments – Kymriah (Tisagenlecleucel) – Package Insert (2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM573941.pdf
-
-
-
-
177
-
-
85148923556
-
-
European Commission (EC) Volume 4 Good Manufacturing Practice: Guidelines to GoodManufacturing Practice Specific to Advanced Therapy Medicinal Products (Novembber2017); ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf
-
European Commission (EC) Volume 4 Good Manufacturing Practice: Guidelines to GoodManufacturing Practice Specific to Advanced Therapy Medicinal Products (Novembber2017); ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf
-
-
-
-
178
-
-
85148924388
-
-
EMA Press Release: European Medicines Agency Confirms Positive Benefit-Risk Balanceof MabThera – Batches Produced at the Vacaville Manufacturing Site Do Not Pose Riskto Public Health, (May 2012); www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/05/WC500127776.pdf
-
EMA Press Release: European Medicines Agency Confirms Positive Benefit-Risk Balanceof MabThera – Batches Produced at the Vacaville Manufacturing Site Do Not Pose Riskto Public Health, (May 2012); www.ema.europa.eu/docs/en_GB/document_library/Press_release/2012/05/WC500127776.pdf
-
-
-
-
179
-
-
84873649040
-
Case study: A novel bacterial contamination in cell culture production – leptospira licerasiae; pda website
-
Chen, J., Bergevin, J., et. al, Case Study: A Novel Bacterial Contamination in Cell Culture Production – Leptospira Licerasiae; PDA website, PDA J Pharm Sci and Tech. (2012), 66:580–591
-
(2012)
PDA J Pharm Sci and Tech
, vol.66
, pp. 580-591
-
-
Chen, J.1
Bergevin, J.2
-
180
-
-
85148921413
-
-
FDA Drugs – Guidance, Compliance & Regulatory Information: Questions and Answerson Current Good Manufacturing Practices—Production and Process Controls –
-
FDA Drugs – Guidance, Compliance & Regulatory Information: Questions and Answerson Current Good Manufacturing Practices—Production and Process Controls –
-
-
-
-
181
-
-
85148922013
-
-
www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124782.htm#14
-
CanLeptospira Species Penetrate Sterilizing-grade Filters?; FDA website, www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124782.htm#14.
-
-
-
-
182
-
-
85148915486
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf
-
ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities andBiotechnological/Biological Entities) (May 2012); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf
-
-
-
-
183
-
-
85148921615
-
-
ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
-
EC Directive 2001/83/EC of the European Parliament and Council, Concerning CommunityCode Relating to Medicinal Products for Human Use (October 2012); ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf
-
-
-
-
184
-
-
85148924948
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610795.pdf
-
FDA Draft Guidance for Industry: Chemistry, Manufacturing, and Control (CMC) Informationfor Human Gene Therapy Investigational New Drug Applications (INDs) (July2018); www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM610795.pdf
-
-
-
-
185
-
-
85148926420
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM202439.pdf
-
FDA Guidance for Industry: Characterization and Qualification of Cell Substrates andOther Biological Materials Used in the Production of Viral Vaccines for InfectiousDisease Indications (February 2010); www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM202439.pdf
-
-
-
-
186
-
-
85148917343
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002779/WC500169242.pdf
-
EMA European Public Assessment Report (EPAR): Vimizim (Elosulfase Alfa) (February2014); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002779/WC500169242.pdf
-
-
-
-
187
-
-
85148923771
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004143/WC500235780.pdf
-
EMA European Public Assessment Report (EPAR): Tecentriq (Atezolizumab) (July 2017);www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004143/WC500235780.pdf
-
-
-
-
188
-
-
85148925250
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003731/WC500198227.pdf
-
EMA European Public Assessment Report (EPAR): Blincyto (Blinatumomab) (September2015); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003731/WC500198227.pdf
-
-
-
-
189
-
-
85148916975
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM469575.pdf
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Imlygic (Talimogene Laherparepvec) – Package Insert (2015); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM469575.pdf
-
-
-
-
190
-
-
85148916060
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM589541.pdf
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Luxturna (Voretigene Neparvovec-rzyl) – Package Insert (2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM589541.pdf
-
-
-
-
191
-
-
85148919090
-
-
www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm589507.htm
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Luxturna (Voretigene Neparvovec-rzyl) – Approval History, Letters, Reviews, and RelatedDocuments – CMC Review (December 8, 2017); www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm589507.htm
-
-
-
-
192
-
-
85148920596
-
-
www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566166.pdf
-
FDA Advisory Committee Meetings – Meeting of the Cellular, Tissue, and GeneTherapies Advisory Committee: Novartis Pharmaceuticals, Kymriah (Tisagenlecleucel) –FDA Advisory Committee Briefing Document Prepared by the FDA (July 12, 2017);www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM566166.pdf
-
-
-
-
193
-
-
85148918419
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002771/WC500201082.pdf
-
EMA European Public Assessment Report (EPAR): Imlygic (Talimogene Laherparepvec)(October 2015); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002771/WC500201082.pdf
-
-
-
-
194
-
-
85148920487
-
-
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252056.pdf
-
EMA Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene Therapy MedicinalProducts (March 2018); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252056.pdf
-
-
-
-
195
-
-
85148922415
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002145/WC500135476.pdf
-
EMA European Public Assessment Report (EPAR): Glybera (Alipogene Tiparvovec) (July2012); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002145/WC500135476.pdf
-
-
-
-
196
-
-
85148922263
-
-
wayback.archive-it.org/7993/20161023095754/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm312929.htm
-
FDA Inspections, Compliance, Enforcement and Criminal Investigations – Warning Letters:Warning Letter to Sanofi Pasteur, July 12, 2012; wayback.archive-it.org/7993/20161023095754/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm312929.htm
-
-
-
-
197
-
-
85148916724
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004280/WC500249349.pdf
-
EMA European Public Assessment Report (EPAR): Semglee (Insulin Glargine, Biosimilarto Lantus) (January 2018); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004280/WC500249349.pdf
-
-
-
-
198
-
-
85148919491
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002835/WC500175383.pdf
-
EMA European Public Assessment Report (EPAR): Abasria (Insulin Glargine) (June 2014);www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002835/WC500175383.pdf
-
-
-
-
199
-
-
85148924891
-
-
www.ema.europa.eu/documents/assessment-report/flixabi-epar-public-assessment-report_en.pdf
-
EMA European Public Assessment Report (EPAR): Inflixabi (Infliximab, Biosimilarto Remicade) (April 2016); www.ema.europa.eu/documents/assessment-report/flixabi-epar-public-assessment-report_en.pdf
-
-
-
-
200
-
-
85148916417
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM336020.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Flublok (Seasonal FluVaccine) – Package Insert (March 2017); www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM336020.pdf
-
-
-
-
201
-
-
85148916765
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Cervarix (HumanPapillomavirus Recombinant Vaccine) – Package Insert (2009); www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf
-
-
-
-
202
-
-
85148921070
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Elelyso (TaligluceraseAlfa) – Package Insert (2016); www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM186981.pdf
-
-
-
-
203
-
-
85148927317
-
-
www.sarepta.com
-
Sarepta Therapeutics, Press Release – Sarepta Therapeutics Announces that Phase 1/2aDuchenne Muscular Dystrophy (DMD) Micro-Dystrophin Gene Therapy Trial Placed onClinical Hold Due to an Out-of-Specification Production Lot; No Observed Safety Events(May 25, 2018); Sarepta Therapeutics website – News Releases, www.sarepta.com
-
-
-
-
204
-
-
85148919867
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM573941.pdf
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data – Kymriah(Tisagenlecleucel) – Package Insert (2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM573941.pdf
-
-
-
-
205
-
-
85148916665
-
-
static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5aa2ff8953450a815ebf3377/1520631693367/Manufacturing-WP-2017.pdf
-
Baaj, A., Kaitin, K. I. and Serebrox, M., Manufacturing Strategy for Diverse Biologic Pipelines of the Future, Tuft Center for Study of Drug Development (October 2017); static1.squarespace.com/static/5a9eb0c8e2ccd1158288d8dc/t/5aa2ff8953450a815ebf3377/1520631693367/Manufacturing-WP-2017.pdf
-
-
-
-
206
-
-
85148917239
-
-
www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004195/WC500243897.pdf
-
EMA European Public Assessment Report (EPAR): Adynovi (Rurioctocog Alfa Pegol)(November 2017); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004195/WC500243897.pdf
-
-
-
-
207
-
-
85148927280
-
-
www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM561316.pdf
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Rebinyn (Recombinant Coagulation Factor IX, GlycoPEGylated) – Package Insert (June 2017);www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM561316.pdf
-
-
-
-
208
-
-
85148916794
-
-
www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Palynziq (Pegvaliase-pqpz) – Package Insert (May 2018); www.accessdata.fda.gov/drugsatfda_docs/label/2018/761079s000lbl.pdf
-
-
-
-
209
-
-
84955057603
-
Associate chief, fda office of biotech products – immunology and proteintherapeutics lab
-
American Association of PharmaceuticalScientists (AAPS) National Biotech Conference, May 2012, as stated in the InternationalPharmaceutical Quality (IPQ) Newsletter June
-
Kirschner, S., Associate Chief, FDA Office of Biotech Products – Immunology and ProteinTherapeutics Lab, Ask the Regulatory Session, American Association of PharmaceuticalScientists (AAPS) National Biotech Conference, May 2012, as stated in the InternationalPharmaceutical Quality (IPQ) Newsletter (June2012); www.IPQpubs.com
-
(2012)
Ask the Regulatory Session
-
-
Kirschner, S.1
-
210
-
-
85148916428
-
-
FDA Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products(August 2014); https://www.fda.gov/downloads/drugs/guidances/ucm338856.pdf
-
FDA Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products(August 2014); https://www.fda.gov/downloads/drugs/guidances/ucm338856.pdf
-
-
-
-
211
-
-
85148925487
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Myotarg (GemtuzumabOzogamicin): Approval History, Letters, Reviews and Related Documents – Package Insert(April 2018); www.accessdata.fda.gov/drugsatfda_docs/label/2018/761060s001lbl.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Myotarg (GemtuzumabOzogamicin): Approval History, Letters, Reviews and Related Documents – Package Insert(April 2018); www.accessdata.fda.gov/drugsatfda_docs/label/2018/761060s001lbl.pdf
-
-
-
-
212
-
-
85148926013
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Adcetris (BentuximabVedotin): Approval History, Letters, Reviews and Related Documents – Package Insert (March2018); www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Adcetris (BentuximabVedotin): Approval History, Letters, Reviews and Related Documents – Package Insert (March2018); www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf
-
-
-
-
213
-
-
85148924774
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Besponsa (InotuzumabOzogamicin): Approval History, Letters, Reviews and Related Documents – Package Insert(August 2017);
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Besponsa (InotuzumabOzogamicin): Approval History, Letters, Reviews and Related Documents – Package Insert(August 2017); www.accessdata.fda.gov/drugsatfda_docs/label/2017/761040s000lbl.pdf
-
-
-
-
214
-
-
85148924935
-
-
FDA Guidance For Industry: Sterile Drug Products Produced by Aseptic Processing –Current Good Manufacturing Practice (September 2004); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070342.pdf
-
FDA Guidance For Industry: Sterile Drug Products Produced by Aseptic Processing –Current Good Manufacturing Practice (September 2004); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070342.pdf
-
-
-
-
215
-
-
85148924562
-
-
EU EudraLex The Rules Governing Medicinal Products in the European Union, Volume4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human andVeterinary Use – Annex 1: Manufacture of Sterile Medicinal Products (November 2008); ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf
-
EU EudraLex The Rules Governing Medicinal Products in the European Union, Volume4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human andVeterinary Use – Annex 1: Manufacture of Sterile Medicinal Products (November 2008); ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf
-
-
-
-
216
-
-
85148916790
-
-
PDA Points to Consider for Aseptic Processing, Part 1 (January 2015); PDA website, www.PDA.org
-
PDA Points to Consider for Aseptic Processing, Part 1 (January 2015); PDA website, www.PDA.org
-
-
-
-
217
-
-
85148925478
-
-
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme(PIC/S): Recommendation on the Validation of Aseptic Processing (January 2011); PIC/Swebsite, picscheme.org/en/publications
-
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme(PIC/S): Recommendation on the Validation of Aseptic Processing (January 2011); PIC/Swebsite, picscheme.org/en/publications
-
-
-
-
218
-
-
85148918115
-
-
PDA Points to Consider for Aseptic Processing, Part 2 (May 2016); PDA website, www.PDA.org
-
PDA Points to Consider for Aseptic Processing, Part 2 (May 2016); PDA website, www.PDA.org
-
-
-
-
219
-
-
85148923592
-
-
European Commission – EudraLex the Rules Governing Medicinal Products in the EuropeanUnion, Volume 4, Good Manufacturing Practice: Guidelines on Good Manufacturing PracticeSpecific to Advanced Therapy Medicinal Products (November 2017); ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf
-
European Commission – EudraLex the Rules Governing Medicinal Products in the EuropeanUnion, Volume 4, Good Manufacturing Practice: Guidelines on Good Manufacturing PracticeSpecific to Advanced Therapy Medicinal Products (November 2017); ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf
-
-
-
-
220
-
-
85148919355
-
-
FDA Guidance For Industry: CGMP For Phase 1 Investigational Drugs (July 2008); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070273.pdf?utm_campaign=Google2%26;utm_source=fdaSearch%26;utm_medium=website%26;utm_term=cgmpphase1guidance%26;utm_content=1
-
FDA Guidance For Industry: CGMP For Phase 1 Investigational Drugs (July 2008); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070273.pdf?utm_campaign=Google2%26;utm_source=fdaSearch%26;utm_medium=website%26;utm_term=cgmpphase1guidance%26;utm_content=1
-
-
-
-
221
-
-
85148916019
-
-
European Commission – EudraLex the Rules Governing Medicinal Products in the EuropeanUnion, Volume 4, Detailed Commission Guidelines on Good Manufacturing Practice forInvestigational Medicinal Products for Human Use, Pursuint to the Second Subparagraph ofArticle 63(1) of Regulation (EU) No 536/2014 (December 2017); ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guideline_adopted_1_en_act_part1_v3.pdf
-
European Commission – EudraLex the Rules Governing Medicinal Products in the EuropeanUnion, Volume 4, Detailed Commission Guidelines on Good Manufacturing Practice forInvestigational Medicinal Products for Human Use, Pursuint to the Second Subparagraph ofArticle 63(1) of Regulation (EU) No 536/2014 (December 2017); ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guideline_adopted_1_en_act_part1_v3.pdf
-
-
-
-
222
-
-
85148918592
-
-
ICH The Common Technical Document For the Registration of Pharmaceuticals ForHuman Use: Quality – M4Q(R1): Quality Overall Summary of Module 2, Module 3 Quality(September 2002); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf
-
ICH The Common Technical Document For the Registration of Pharmaceuticals ForHuman Use: Quality – M4Q(R1): Quality Overall Summary of Module 2, Module 3 Quality(September 2002); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf
-
-
-
-
223
-
-
85148918354
-
-
FDA Guidance For Industry: For the Submission of Chemistry, Manufacturing, and ControlsInformation for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibodyfor In Vivo Use (August 1996); www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/general/ucm173477.pdf
-
FDA Guidance For Industry: For the Submission of Chemistry, Manufacturing, and ControlsInformation for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibodyfor In Vivo Use (August 1996); www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/general/ucm173477.pdf
-
-
-
-
224
-
-
85148926124
-
-
FDA Recalls, Market Withdrawals, & Safety Alerts – Enforcement Reports: EnforcementReport for Week of June 25, 2014 – Drugs – TEV-TROPIN [Somatropin, rDNA origin]; www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
-
FDA Recalls, Market Withdrawals, & Safety Alerts – Enforcement Reports: EnforcementReport for Week of June 25, 2014 – Drugs – TEV-TROPIN [Somatropin, rDNA origin]; www.fda.gov/Safety/Recalls/EnforcementReports/default.htm
-
-
-
-
225
-
-
85148916041
-
-
FDA Establishment Inspection Report: Celltrion Inc (June 2, 2017); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM603271.pdf
-
FDA Establishment Inspection Report: Celltrion Inc (June 2, 2017); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM603271.pdf
-
-
-
-
226
-
-
85148924595
-
-
FDA Inspections, Compliance, Enforcement, and Criminal Investigations – Warning Letters:Celltrion Inc. (January 26, 2018); www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm594395.htm
-
FDA Inspections, Compliance, Enforcement, and Criminal Investigations – Warning Letters:Celltrion Inc. (January 26, 2018); www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm594395.htm
-
-
-
-
227
-
-
85148917287
-
-
FDA CDER Freedom of Information Act (FOIA) Electronic Reading Room: Celltrion FDA Form 483(July 9–17, 2018); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM615956.pdf
-
FDA CDER Freedom of Information Act (FOIA) Electronic Reading Room: Celltrion FDA Form 483(July 9–17, 2018); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM615956.pdf
-
-
-
-
228
-
-
85148916186
-
-
ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (March 1999); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (March 1999); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
-
-
-
229
-
-
85148921964
-
-
ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities andBiotechnological/Biological Entities) (May 2012); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf
-
ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities andBiotechnological/Biological Entities) (May 2012); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf
-
-
-
-
230
-
-
85148927480
-
-
ICH Q3C(R5) Impurities: Guideline for Residual Solvents (February 2011); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Step4/Q3C_R5_Step4.pdf
-
ICH Q3C(R5) Impurities: Guideline for Residual Solvents (February 2011); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3C/Step4/Q3C_R5_Step4.pdf
-
-
-
-
231
-
-
85148916571
-
-
ICH Q3D Guideline for Elemental Impurities (December 2014); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4.pdf
-
ICH Q3D Guideline for Elemental Impurities (December 2014); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4.pdf
-
-
-
-
232
-
-
85148924843
-
-
Code of Federal Regulations (CFR) – Title 21 Food and Drugs: Part 610.15(b) ConstituentMaterials – Extraneous Protein; www.ecfr.gov/cgi-bin/text-idx?SID=870055794fb542c693cd7dddc011c4e0&mc=true&node=pt21.7.610&rgn=div5#se21.7.610_115
-
Code of Federal Regulations (CFR) – Title 21 Food and Drugs: Part 610.15(b) ConstituentMaterials – Extraneous Protein; www.ecfr.gov/cgi-bin/text-idx?SID=870055794fb542c693cd7dddc011c4e0&mc=true&node=pt21.7.610&rgn=div5#se21.7.610_115
-
-
-
-
233
-
-
85148918163
-
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Imlygic (Talimogene Laherparepvec) – Package Insert (October 2015); wayback.archive-it.org/7993/20170112213642/http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM469575.pdf
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Imlygic (Talimogene Laherparepvec) – Package Insert (October 2015); wayback.archive-it.org/7993/20170112213642/http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM469575.pdf
-
-
-
-
234
-
-
85148923830
-
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Luxturna (Voretigene Neparvovec-rzyl) – Package Insert (December 2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM589541.pdf
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Luxturna (Voretigene Neparvovec-rzyl) – Package Insert (December 2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM589541.pdf
-
-
-
-
235
-
-
85148925347
-
-
EMA Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene Therapy MedicinalProducts (March 22, 2018); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252056.pdf
-
EMA Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene Therapy MedicinalProducts (March 22, 2018); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252056.pdf
-
-
-
-
236
-
-
85148924800
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Lucentis (Ranibizumab):Approval History, Letters, Reviews and Related Documents – Package Insert (April 2017);www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Lucentis (Ranibizumab):Approval History, Letters, Reviews and Related Documents – Package Insert (April 2017);www.accessdata.fda.gov/drugsatfda_docs/label/2017/125156s114lbl.pdf
-
-
-
-
237
-
-
85148919353
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Perjeta (Pertuzumab):Approval History, Letters, Reviews and Related Documents – Package Insert (December2017); www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Perjeta (Pertuzumab):Approval History, Letters, Reviews and Related Documents – Package Insert (December2017); www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf
-
-
-
-
238
-
-
85148922026
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Lumoxiti (MoxetumomabPasudotox-tdfk): Approval History, Letters, Reviews and Related Documents –Package Insert (September 2018); https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Lumoxiti (MoxetumomabPasudotox-tdfk): Approval History, Letters, Reviews and Related Documents –Package Insert (September 2018); https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761104s000lbl.pdf
-
-
-
-
239
-
-
85148920981
-
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Yescarta (Axicabtagene Ciloleucel) – Package Insert (2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM581226.pdf
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Yescarta (Axicabtagene Ciloleucel) – Package Insert (2017); www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM581226.pdf
-
-
-
-
240
-
-
85148925086
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Palynziq (Pegvaliase-pqpz):Approval History, Letters, Reviews and Related Documents – FDA Approval Letter(May 24, 2018); www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761079Orig1s000ltr.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Palynziq (Pegvaliase-pqpz):Approval History, Letters, Reviews and Related Documents – FDA Approval Letter(May 24, 2018); www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761079Orig1s000ltr.pdf
-
-
-
-
241
-
-
85148919385
-
-
Li, K., Rogers, G., et.al., Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products; PDA J Pharm Sci and Tech (2015), 69: 590–619; PDA website, www.PDA.org
-
Li, K., Rogers, G., et.al., Creating a Holistic Extractables and Leachables (E&L) Program for Biotechnology Products; PDA J Pharm Sci and Tech (2015), 69: 590–619; PDA website, www.PDA.org
-
-
-
-
242
-
-
85148920080
-
-
EMA Guideline on the Requirements for Quality Documentation Concerning BiologicalInvestigational Medicinal Products in Clinical Trials (September 2018); www.ema.europa.eu/documents/scientific-guideline/guideline-requirements-quality-documentation-concerningbiological-investigational-medicinal_en-0.pdf
-
EMA Guideline on the Requirements for Quality Documentation Concerning BiologicalInvestigational Medicinal Products in Clinical Trials (September 2018); www.ema.europa.eu/documents/scientific-guideline/guideline-requirements-quality-documentation-concerningbiological-investigational-medicinal_en-0.pdf
-
-
-
-
243
-
-
85148915792
-
-
ICH M4Q(R1): Quality Overall Summary of Module 2, Module 3 Quality (September 2002);www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf
-
ICH M4Q(R1): Quality Overall Summary of Module 2, Module 3 Quality (September 2002);www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf
-
-
-
-
244
-
-
85148921840
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Tremfya (Guselkumab):Approval History, Letters, Reviews and Related Documents – FDA BLA Approval Letter (July13, 2017); www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761061Orig1s000ltr.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Tremfya (Guselkumab):Approval History, Letters, Reviews and Related Documents – FDA BLA Approval Letter (July13, 2017); www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761061Orig1s000ltr.pdf
-
-
-
-
245
-
-
85148918022
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Mepsevii (VestronidaseAlfa-vjbk): Approval History, Letters, Reviews and Related Documents – FDA BLA ApprovalLetter (November 15, 2017); www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761047Orig1s000ltr.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Mepsevii (VestronidaseAlfa-vjbk): Approval History, Letters, Reviews and Related Documents – FDA BLA ApprovalLetter (November 15, 2017); www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761047Orig1s000ltr.pdf
-
-
-
-
246
-
-
85148923469
-
-
FDA Guidance for Industry: CGMP For Phase 1 Investigational Drugs (July 2008); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM
-
FDA Guidance for Industry: CGMP For Phase 1 Investigational Drugs (July 2008); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM
-
-
-
-
247
-
-
85148920643
-
-
pdf
-
pdf
-
-
-
-
248
-
-
85148925484
-
-
Qiu, J., Li, K., et. al., Risk-Based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses; PDA J Pharm Sciand Tech (2015), 69: 334–345; journal.pda.org/content/69/3/33e4
-
Qiu, J., Li, K., et. al., Risk-Based Strategy to Determine Testing Requirement for the Removal of Residual Process Reagents as Process-related Impurities in Bioprocesses; PDA J Pharm Sciand Tech (2015), 69: 334–345; journal.pda.org/content/69/3/33e4
-
-
-
-
249
-
-
85148927250
-
-
FDA Guidance for Industry: For the Submission of Chemistry, Manufacturing, and ControlsInformation for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibodyfor In Vivo Use (August 1996); www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/general/ucm173477.pdf
-
FDA Guidance for Industry: For the Submission of Chemistry, Manufacturing, and ControlsInformation for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibodyfor In Vivo Use (August 1996); www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/general/ucm173477.pdf
-
-
-
-
250
-
-
85148919025
-
-
EMA Guideline on Quality, Non-Clinical and Clinical Aspects of Medicinal ProductsContaining Genetically Modified Cells (July 2018); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252709.pdf
-
EMA Guideline on Quality, Non-Clinical and Clinical Aspects of Medicinal ProductsContaining Genetically Modified Cells (July 2018); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252709.pdf
-
-
-
-
251
-
-
85148920217
-
-
EMA Guideline on Human Cell-Based Medicinal Products (May 2008); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003894.pdf
-
EMA Guideline on Human Cell-Based Medicinal Products (May 2008); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003894.pdf
-
-
-
-
252
-
-
85148923929
-
-
FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of aTherapeutic Protein Product to a Reference Product (April 2015); www.fda.gov/downloads/drugs/guidances/ucm291134.pdf
-
FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of aTherapeutic Protein Product to a Reference Product (April 2015); www.fda.gov/downloads/drugs/guidances/ucm291134.pdf
-
-
-
-
253
-
-
85148926052
-
-
EMA Draft Guideline on Similar Biological Medicinal Products Containing Biotechology-DerivedProteins as Active Substance – Quality Issues (Revision 1) (May 2012); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127960.pdf
-
EMA Draft Guideline on Similar Biological Medicinal Products Containing Biotechology-DerivedProteins as Active Substance – Quality Issues (Revision 1) (May 2012); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127960.pdf
-
-
-
-
254
-
-
85148923948
-
-
FDA Advisory Committee Meetings – Meeting of the Arthritis Advisory Committee: SandozErlezi (Etanercept, Biosimilar Enbrel) – FDA Advisory Committee Briefing DocumentPrepared by the FDA (July 13, 2016); www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510493.pdf
-
FDA Advisory Committee Meetings – Meeting of the Arthritis Advisory Committee: SandozErlezi (Etanercept, Biosimilar Enbrel) – FDA Advisory Committee Briefing DocumentPrepared by the FDA (July 13, 2016); www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510493.pdf
-
-
-
-
255
-
-
85148919487
-
-
EMA European Public Assessment Report (EPAR): Herzuma (Trastuzumab, HerceptinBiosimilar) (December 2017); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002575/WC500249108.pdf
-
EMA European Public Assessment Report (EPAR): Herzuma (Trastuzumab, HerceptinBiosimilar) (December 2017); www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002575/WC500249108.pdf
-
-
-
-
256
-
-
85148917714
-
-
Secretary of Defense, Press Conference at NATO Headquarters (June02, 2002);
-
Donald Rumsfeld, U.S. Secretary of Defense, Press Conference at NATO Headquarters (June02, 2002); www.nato.int/docu/speech/2002/s020606g.htm
-
-
-
Donald Rumsfeld, U.S.1
-
257
-
-
85148923211
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
ICH Q6B Specifications: Test Procedures and Acceptance Criteria For Biotechnological/Biological Products (March 1999); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
-
-
-
258
-
-
85148919914
-
-
Kozlowski, S., and Swann P., Current and Future Issues in the Manufacturing and Development of Monoclonal Antibodies; Adv. Drug Deliv Rev. (2006) 58(5–6): 707–722
-
Kozlowski, S., and Swann P., Current and Future Issues in the Manufacturing and Development of Monoclonal Antibodies; Adv. Drug Deliv Rev. (2006) 58(5–6): 707–722
-
-
-
-
259
-
-
85148922239
-
-
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070273.pdf
-
FDA Guidance for Industry: CGMP For Phase 1 Investigational Drugs (July 2008); www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070273.pdf
-
-
-
-
260
-
-
85148925516
-
-
www.ema.europa.eu/documents/scientific-guideline/guideline-requirements-quality-documentation-concerningbiological-investigational-medicinal_en-0.pdf
-
EMA Guideline on the Requirements For Quality Documentation Concerning BiologicalInvestigational Medicinal Products in Clinical Trials (September 2018); www.ema.europa.eu/documents/scientific-guideline/guideline-requirements-quality-documentation-concerningbiological-investigational-medicinal_en-0.pdf
-
-
-
-
261
-
-
85148926912
-
-
ICH M4Q(R1): Quality Overall Summary of Module 2, Module 3: Quality (September 2002);www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf
-
ICH M4Q(R1): Quality Overall Summary of Module 2, Module 3: Quality (September 2002);www.ich.org/fileadmin/Public_Web_Site/ICH_Products/CTD/M4_R1_Quality/M4Q__R1_.pdf
-
-
-
-
262
-
-
85148917748
-
-
www.ema.europa.eu/documents/scientific-guideline/guideline-development-production-characterisation-specification-monoclonal-antibodies-related_en.pdf
-
EMA Guideline on Development, Production, Characterization, and Specification forMonoclonal Antibodies and Related Products (July 2016): www.ema.europa.eu/documents/scientific-guideline/guideline-development-production-characterisation-specification-monoclonal-antibodies-related_en.pdf
-
-
-
-
263
-
-
85148924513
-
-
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252056.pdf
-
EMA Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene Therapy MedicinalProducts (March 22, 2018); www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252056.pdf
-
-
-
-
264
-
-
85148924860
-
-
www.fda.gov/downloads/drugs/guidances/ucm291134.pdf
-
FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of aTherapeutic Protein Product to a Reference Product (April 2015); www.fda.gov/downloads/drugs/guidances/ucm291134.pdf
-
-
-
-
265
-
-
85148916825
-
-
www.ema.europa.eu/documents/assessment-report/dinutuximab-beta-apeironepar-public-assessment-report_en.pdf
-
EMA European Public Assessment Report (EPAR): Qarziba (Dinutuximab Beta Apeiron)(March 2017); www.ema.europa.eu/documents/assessment-report/dinutuximab-beta-apeironepar-public-assessment-report_en.pdf
-
-
-
-
266
-
-
85148920868
-
-
www.ema.europa.eu/documents/assessment-report/oxervate-epar-public-assessment-report_en.pdf
-
EMA European Public Assessment Report (EPAR): Oxervate (Cenegermin, RecombinantNerve Growth Factor) (May 2017); www.ema.europa.eu/documents/assessment-report/oxervate-epar-public-assessment-report_en.pdf
-
-
-
-
267
-
-
85148926033
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
-
Code of Federal Regulations Title 21 Food and Drugs: Part 211 – Definitions; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
-
-
-
-
268
-
-
85148915952
-
-
ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf
-
EC Directive 2001/83/EC of the European Parliament and Council, Concerning CommunityCode Relating to Medicinal Products For Human Use; ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf
-
-
-
-
269
-
-
85148921176
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.3
-
Code of Federal Regulations Title 21 Food and Drugs: Part 210.3 – Definitions; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=210.3
-
-
-
-
270
-
-
85148918741
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=600.3
-
Code of Federal Regulations Title 21 Food and Drugs: Part 600.3 – Definitions; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=600.3
-
-
-
-
271
-
-
85148917071
-
-
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=610.10
-
Code of Federal Regulations Title 21 Food and Drugs: Part 610.10 – Potency; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=610.10
-
-
-
-
272
-
-
85148919670
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
ICH Q6B Specifications: Test Procedures and Acceptance Criteria For Biotechnological/Biological Products (March 1999); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
-
-
-
273
-
-
85148917618
-
-
www.ema.europa.eu/documents/scientific-guideline/guideline-potency-testing-cell-based-immunotherapy-medicinal-products-treatment-cancerrevision-1_en.pdf
-
EMA Guideline on Potency Testing of Cell Based Immunotherapy Medicinal Products forthe Treatment of Cancer (July 2016); www.ema.europa.eu/documents/scientific-guideline/guideline-potency-testing-cell-based-immunotherapy-medicinal-products-treatment-cancerrevision-1_en.pdf
-
-
-
-
274
-
-
85148924896
-
-
www.ema.europa.eu/documents/scientific-guideline/guideline-development-production-characterisation-specification-monoclonal-antibodies-related_en.pdf
-
EMA Guideline on Development, Production, Characterisation and Specification forMonoclonal Antibodies and Related Products (July 2016); www.ema.europa.eu/documents/scientific-guideline/guideline-development-production-characterisation-specification-monoclonal-antibodies-related_en.pdf
-
-
-
-
275
-
-
85148916636
-
-
Search Drugs@FDA – FDA Approved Drug Products: Crysvita (Burosumab-twza):Approval History, Letters, Reviews and Related Documents – Administrative andCorrespondence Documents – Mid-Cycle Communication Meeting (November 30, 2017);www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761068Orig1s000Admincones.pdf
-
FDA Drugs– Search Drugs@FDA – FDA Approved Drug Products: Crysvita (Burosumab-twza):Approval History, Letters, Reviews and Related Documents – Administrative andCorrespondence Documents – Mid-Cycle Communication Meeting (November 30, 2017);www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761068Orig1s000Admincones.pdf
-
-
-
Fda Drugs, –.1
-
276
-
-
85148918484
-
-
www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761068Orig1s000Approv.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Crysvita (Burosumab-twza):FDA Market Approval Letter (April 17, 2018); www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761068Orig1s000Approv.pdf
-
-
-
-
277
-
-
85148920150
-
-
www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761094Orig1s000ChemR.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Oxervate (Cenegermin-bkbj):Approval History, Letters, Reviews and Related Documents – CMC Review –Executive Summary (August 07, 2018); www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761094Orig1s000ChemR.pdf
-
-
-
-
278
-
-
85148916394
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761094Orig1s000Ltr.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Oxervate (Cenegermin-bkbj):FDA Market Approval Letter (August 22, 2018); www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761094Orig1s000Ltr.pdf
-
-
-
-
279
-
-
85148918812
-
-
www.ema.europa.eu/documents/withdrawal-report/withdrawal-assessment-report-fulphila_en.pdf
-
EMA European Withdrawal Assessment Report (EPAR): Fulphia (Pegfilgrastim, Biosimilarof Neulasta) (October 2016); www.ema.europa.eu/documents/withdrawal-report/withdrawal-assessment-report-fulphila_en.pdf
-
-
-
-
280
-
-
85148921452
-
-
www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000ChemR.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Ocrevus(Ocrelizumab): Approval History, Letters, Reviews and Related Documents – CMCReview – Executive Summary (March 20, 2017); www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000ChemR.pdf
-
-
-
-
281
-
-
85148922027
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761053Orig1s000ltr.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Ocrevus (Ocrelizumab):FDA Market Approval Letter (April 28, 2017); www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761053Orig1s000ltr.pdf
-
-
-
-
282
-
-
85148920039
-
-
www.fda.gov/Drugs/default.htm; CBER, Biological Products & Establishments – Licensed Biological Productswith Supporting Documents: FDA Package Insert, www.fda.gov/BiologicsBloodVaccines/default.htm
-
Product-specific package inserts published on FDA website: CDER, FDA Drugs – SearchDrugs@FDA – FDA Approved Drug Products: FDA Package Insert, www.fda.gov/Drugs/default.htm; CBER, Biological Products & Establishments – Licensed Biological Productswith Supporting Documents: FDA Package Insert, www.fda.gov/BiologicsBloodVaccines/default.htm
-
-
-
-
283
-
-
85148918366
-
-
www.PDA.org
-
Langille, S. E., Particulate Matter in Injectable Drug Products; PDA J Pharm Sci and Tech(2013), 67: 186–200; PDA website, www.PDA.org
-
-
-
-
284
-
-
85148924265
-
-
www.PDA.org
-
Mathonet, S., Mahler, H-C., et.al., Biopharmaceutical Industry Perspective on the Control of Visible Particles in Biotechnology-Derived Injectable Drug Products; PDA J Pharm Sci andTech (2016), 70: 392–408; PDA website, www.PDA.org
-
-
-
-
285
-
-
85148915500
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf
-
ICH Q6A Specifications: Test Procedures and Acceptance Criteria For New Drug Substancesand New Drug Products: Chemical Substances (October 1999); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf
-
-
-
-
286
-
-
85148921224
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
ICH Q6B Specifications: Test Procedures and Acceptance Criteria For Biotechnological/Biological Products (March 1999); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
-
-
-
287
-
-
85148926674
-
-
www.ema.europa.eu/documents/scientific-guideline/guideline-development-production-characterisation-specification-monoclonal-antibodies-related_en.pdf
-
EMA Guideline on Development, Production, Characterisation and Specification forMonoclonal Antibodies and Related Products (July 2016); www.ema.europa.eu/documents/scientific-guideline/guideline-development-production-characterisation-specification-monoclonal-antibodies-related_en.pdf
-
-
-
-
288
-
-
85148919689
-
-
www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125526Orig1s000ChemR.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Nucala (Mepolizumab):Approval History, Letters, Reviews and Related Documents – Chemistry Reviews – OPQCMC Review Data Sheet (July 10, 2015); www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125526Orig1s000ChemR.pdf
-
-
-
-
289
-
-
85148917256
-
-
www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024Orig1s000OtherR.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Amjevita (Adalimumab-atto):Approval History, Letters, Reviews and Related Documents – Other Reviews –CDRH Consult (September 22, 2016); www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761024Orig1s000OtherR.pdf
-
-
-
-
290
-
-
85148918906
-
-
www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761077Orig1s000OtherR.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Aimovig (Erenumab-aooe):Approval History, Letters, Reviews and Related Documents – Other Reviews –CDRH Consult (January 02, 2018); www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761077Orig1s000OtherR.pdf
-
-
-
-
291
-
-
85148921674
-
-
www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm589507.htm
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Luxturna (Voretigene Neparvovec-rzyl) – Chemistry Review – DCGT CMC Review Data Sheet(December 08, 2017); www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm589507.htm
-
-
-
-
292
-
-
85148916449
-
-
www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm581222.htm
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data –Yescarta (Axicabtagene Ciloleucel) – Chemistry Review – DCGT CMC Review Data Sheet(November 29, 2017); www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/ucm581222.htm
-
-
-
-
293
-
-
85148920471
-
-
www. ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5C/Step4/Q5C_ Guideline.pdf
-
ICH Q5C Stability Testing of Biotechnological/Biological Products (November 1995); www. ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5C/Step4/Q5C_ Guideline.pdf
-
-
-
-
294
-
-
85148921041
-
-
www.ema.europa.eu/documents/scientific-guideline/ guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf
-
EMA Guideline on the Quality, Non-clinical and Clinical Aspects of Gene Therapy Medicinal Products (March 2018); www.ema.europa.eu/documents/scientific-guideline/ guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf
-
-
-
-
295
-
-
85148917102
-
-
www.ema.europa.eu/documents/scientific- guideline/draft-guideline-quality-non-clinical-clinical-aspects-medicinal-products-containing- genetically_en.pdf
-
EMA Guideline on the Quality, Non-clinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells (July 2018); www.ema.europa.eu/documents/scientific- guideline/draft-guideline-quality-non-clinical-clinical-aspects-medicinal-products-containing- genetically_en.pdf
-
-
-
-
296
-
-
85148923279
-
-
www.ema.europa.eu/ documents/scientific-guideline/guideline-human-cell-based-medicinal-products_en.pdf
-
EMA Guideline on Human Cell-Based Medicinal Products (May 2008); www.ema.europa.eu/ documents/scientific-guideline/guideline-human-cell-based-medicinal-products_en.pdf
-
-
-
-
297
-
-
85148926946
-
-
www.ema.europa.eu/ documents/scientific-guideline/guideline-requirements-quality-documentation-concerningbiological- investigational-medicinal_en-0.pdf
-
EMA Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials (September 2018); www.ema.europa.eu/ documents/scientific-guideline/guideline-requirements-quality-documentation-concerningbiological- investigational-medicinal_en-0.pdf
-
-
-
-
298
-
-
85148918402
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761079Orig 1s000ltr.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Palynziq (Pegvaliase-pqpz): Approval History, Letters, Reviews and Related Documents – FDA Market Approval Letter (May 24, 2018); www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761079Orig 1s000ltr.pdf
-
-
-
-
299
-
-
85148919948
-
-
ipimediaworld.com/wp-content/uploads/2017/10/Tungsten-in-theproduction- 1.pdf
-
Zeiss, B., Tungsten in the Production of Prefillable Syringes – Also Possible Without Tungsten; IPI (2017), 9(3): 126–130; ipimediaworld.com/wp-content/uploads/2017/10/Tungsten-in-theproduction- 1.pdf
-
-
-
-
300
-
-
85148916141
-
-
www.accessdata. fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000AdminCorres.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Ocrevus (Ocrelizumab): Approval History, Letters, Reviews and Related Documents – Administrative and Correspondence Documents – FDA Type C CMC-Focused Meeting Minutes (February 29, 2016); www.accessdata. fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000AdminCorres.pdf
-
-
-
-
301
-
-
85148920526
-
-
www.ich.org/fileadmin/Public_ Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf
-
ICH Q8 (R2) Pharmaceutical Development (August 2009); www.ich.org/fileadmin/Public_ Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf
-
-
-
-
302
-
-
85148925062
-
-
www.ich.org/fileadmin/Public_Web_Site/ ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf
-
ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) (May 2012); www.ich.org/fileadmin/Public_Web_Site/ ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf
-
-
-
-
303
-
-
85148926199
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/ Biological Products (March 1999); www.ich.org/fileadmin/Public_Web_Site/ICH_Products/ Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf
-
-
-
-
304
-
-
85148923107
-
-
ec.europa.eu/health/sites/health/ files/files/eudralex/vol-10/guideline_adopted_1_en_act_part1_v3.pdf
-
European Commission (EC) Guidelines on Good Manufacturing Practices for Investigational Medicinal Products for Human Use (December 08, 2017); ec.europa.eu/health/sites/health/ files/files/eudralex/vol-10/guideline_adopted_1_en_act_part1_v3.pdf
-
-
-
-
305
-
-
85148920546
-
-
ec.europa.eu/health/sites/ health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf
-
European Commission (EC) Guidelines on Good Manufacturing Practices Specific to Advanced Therapy Medicinal Products (November 22, 2017); ec.europa.eu/health/sites/ health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf
-
-
-
-
306
-
-
85148916950
-
-
www.accessdata. fda.gov/drugsatfda_docs/nda/2017/761069Orig1s000AdminCorres.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Imfinzi (Durvalumab): Approval History, Letters, Reviews and Related Documents – Administrative and Correspondence Documents – Information Request Letter (December 20, 2016); www.accessdata. fda.gov/drugsatfda_docs/nda/2017/761069Orig1s000AdminCorres.pdf
-
-
-
-
307
-
-
85148917146
-
-
www.fda.gov/BiologicsBloodVaccines/ CellularGeneTherapyProducts/ApprovedProducts/ucm573706.htm
-
FDA Vaccines, Blood & Biologics: Licensed Biologic Products with Supporting Data – Kymriah (Tisagenlecleucel) – Approval History, Letters, Reviews and Related Documents – Mid-Cycle Commuication Summary (May 18, 2017); www.fda.gov/BiologicsBloodVaccines/ CellularGeneTherapyProducts/ApprovedProducts/ucm573706.htm
-
-
-
-
308
-
-
85148921162
-
-
www.ich.org/fileadmin/ Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf
-
ICH Q6A Specifications: Test Procedures and Acceptance Criteria For New Drug Substances and New Drug Products: Chemical Substances (October 1999); www.ich.org/fileadmin/ Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4.pdf
-
-
-
-
309
-
-
85148922379
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761046Orig1s0 00ltr.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Zinplava (Bezlotoxumab): Approval History, Letters, Reviews and Related Documents – FDA Market Approval Letter (October 21, 2016); www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761046Orig1s0 00ltr.pdf
-
-
-
-
310
-
-
85148925567
-
-
www.accessdata.fda.gov/drugsatfda_docs/appletter/2 017/761047Orig1s000ltr.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Mepsevii (Vestronidase Alfa-vjbk): Approval History, Letters, Reviews and Related Documents – FDA Market Approval Letter (November 15, 2017); www.accessdata.fda.gov/drugsatfda_docs/appletter/2 017/761047Orig1s000ltr.pdf
-
-
-
-
311
-
-
85148925007
-
-
www.ema.europa.eu/documents/assessment-report/kanuma-epar-public-assessmentreport_ en.pdf
-
EMA European Public Assessment Report (EPAR): Kanuma (Sebelipase Alfa) (June 2015); www.ema.europa.eu/documents/assessment-report/kanuma-epar-public-assessmentreport_ en.pdf
-
-
-
-
312
-
-
85148925601
-
-
www.fda.gov/downloads/ drugs/guidances/ucm291134.pdf
-
FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product (April 2015); www.fda.gov/downloads/ drugs/guidances/ucm291134.pdf
-
-
-
-
313
-
-
85148920872
-
-
www.ema.europa.eu/ documents/scientific-guideline/guideline-similar-biological-medicinal-products-containingbiotechnology- derived-proteins-active_en-0.pdf
-
EMA Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (Revision 1) (May 2014); www.ema.europa.eu/ documents/scientific-guideline/guideline-similar-biological-medicinal-products-containingbiotechnology- derived-proteins-active_en-0.pdf
-
-
-
-
314
-
-
85148920011
-
-
www.who.int/biologicals/areas/biological_therapeutics/ BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
-
World Health Organization (WHO) Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs) (October 2009); www.who.int/biologicals/areas/biological_therapeutics/ BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf
-
-
-
-
315
-
-
85148916317
-
-
www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510293.pdf
-
FDA Advisory Committee Meetings – Meeting of the Arthritis Advisory Committee: Amgen ABP-501 (Adalimumab, Biosimilar to Humira) – FDA Advisory Committee Briefing Document Prepared by the FDA (July 12, 2016); www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510293.pdf
-
-
-
-
316
-
-
85148925002
-
-
ir.aptevotherapeutics.com/static-files/506443c3-3e2b-498d-9646-78e582b5ccf8
-
Aptevo Therapeutics webpage – Investors – Financial Reports: United States Securies and Exchange Commission (SEC) Form 10-Q for the Quarterly Period Ended September 30, 2016; ir.aptevotherapeutics.com/static-files/506443c3-3e2b-498d-9646-78e582b5ccf8
-
-
-
-
317
-
-
85148917694
-
-
ir.aptevotherapeutics.com/news-releases/ news-release-details/aptevo-therapeutics-announces-new-ixinity-supply-available-may
-
Aptevo Therapeutics webpage – News – March 15, 2017 – Aptevo Therapeutics Announces New IXINITY Supply Available May 2017; ir.aptevotherapeutics.com/news-releases/ news-release-details/aptevo-therapeutics-announces-new-ixinity-supply-available-may
-
-
-
-
318
-
-
85148922149
-
-
www.fool.com/earnings/call-transcripts/2018/07/18/novartis-ag-nvs-q2-2018-earnings-conference- call-t.aspx
-
Motley Fool Transcript of Novartis Second-Quarter (Q2) Earnings Report (July 18, 2018); www.fool.com/earnings/call-transcripts/2018/07/18/novartis-ag-nvs-q2-2018-earnings-conference- call-t.aspx
-
-
-
-
319
-
-
85148922187
-
-
www.ema.europa.eu/documents/ assessment-report/shingrix-epar-public-assessment-report_en.pdf
-
EMA European Public Assessment Report (EPAR): Shingrix (Herpes Zoster Vaccine, Recombinant, Adjuvanted) (January 2018); www.ema.europa.eu/documents/ assessment-report/shingrix-epar-public-assessment-report_en.pdf
-
-
-
-
320
-
-
85148924848
-
-
www. ema.europa.eu/documents/assessment-report/ilumetri-epar-public-assessment-report_en.pdf
-
EMA European Public Assessment Report (EPAR): Ilumetri (Tildrakizumab) (July 2018); www. ema.europa.eu/documents/assessment-report/ilumetri-epar-public-assessment-report_en.pdf
-
-
-
-
321
-
-
85148916716
-
-
www. ema.europa.eu/documents/assessment-report/bavencio-epar-public-assessment-report_en.pdf
-
EMA European Public Assessment Report (EPAR): Bavencio (Avelumab) (July 2017); www. ema.europa.eu/documents/assessment-report/bavencio-epar-public-assessment-report_en.pdf
-
-
-
-
322
-
-
84959042048
-
Authorized manufacturing changes for therapeutic monoclonal antibodies (Mabs) in european public assessment report (epar) documents
-
Vezer, B., Buzas, Z., et.al., Authorized Manufacturing Changes for Therapeutic Monoclonal Antibodies (mAbs) in European Public Assessment Report (EPAR) Documents; Curr Med Res Opin(2016), 32: 829–834
-
(2016)
Curr Med Res Opin
, vol.32
, pp. 829-834
-
-
Vezer, B.1
Buzas, Z.2
-
323
-
-
84954309076
-
Consistency of quality attributes for the glycosylated monoclonal antibody humira® (Adalimumab)
-
Tebbey, P. W., Varga, A., et.al., Consistency of Quality Attributes for the Glycosylated Monoclonal Antibody Humira® (Adalimumab); MAbs(2015), 805–811
-
(2015)
Mabs
, pp. 805-811
-
-
Tebbey, P.W.1
Varga, A.2
-
324
-
-
85148924292
-
-
www.ich.org/fileadmin/Public_Web_Site/ICH_ Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf
-
ICH Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process (November 2004); www.ich.org/fileadmin/Public_Web_Site/ICH_ Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf
-
-
-
-
325
-
-
85148921237
-
-
www.ema.europa.eu/documents/scientific-guideline/ guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf
-
EMA Guideline on the Quality, Non-clinical and Clinical Aspects of Gene Therapy Medicinal Products (March 2018); www.ema.europa.eu/documents/scientific-guideline/ guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf
-
-
-
-
326
-
-
85148916727
-
-
www.ema.europa.eu/documents/scientific- guideline/draft-guideline-quality-non-clinical-clinical-aspects-medicinal-products-containing- genetically_en.pdf
-
EMA Guideline on the Quality, Non-clinical and Clinical Aspects of Medicinal Products Containing Genetically Modified Cells (July 2018); www.ema.europa.eu/documents/scientific- guideline/draft-guideline-quality-non-clinical-clinical-aspects-medicinal-products-containing- genetically_en.pdf
-
-
-
-
327
-
-
85148923690
-
-
www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496611.pdf
-
FDA (Draft) Guidance for Industry: Comparability Protocols for Human Drugs and Biologics – Chemistry, Manufacturing and Controls Information (April 2016); www.fda.gov/downloads/ Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496611.pdf
-
-
-
-
328
-
-
85148915815
-
-
www.fda.gov/downloads/ drugs/guidances/ucm291134.pdf
-
FDA Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product (April 2015); www.fda.gov/downloads/ drugs/guidances/ucm291134.pdf
-
-
-
-
329
-
-
85148916703
-
-
www.accessdata. fda.gov/drugsatfda_docs/nda/2016/761024Orig1s000ChemR.pdf
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Amjevita (Adalimumab-atto, Biosimilar of Humira): Approval History, Letters, Reviews and Related Documents – Chemistry Review(s) – OBP CMC Review Data Sheet (August 15, 2016); www.accessdata. fda.gov/drugsatfda_docs/nda/2016/761024Orig1s000ChemR.pdf
-
-
-
-
330
-
-
85148917375
-
-
www.ema.europa.eu/documents/scientificguideline/ draft-reflection-paper-statistical-methodology-comparative-assessment-qualityattributes- drug_en.pdf
-
EMA Reflection Paper on Statistical methodology for the Comparative Assessment of Quality Attributes in Drug Development (March 2017); www.ema.europa.eu/documents/scientificguideline/ draft-reflection-paper-statistical-methodology-comparative-assessment-qualityattributes- drug_en.pdf
-
-
-
-
331
-
-
85148921817
-
-
www.ema.europa.eu/documents/assessment-report/mvasi-eparpublic- assessment-report_en.pdf
-
EMA European Public Assessment Report (EPAR): Mvasi (Bevacizumab, Biosimilar of Avastin) (January 2018); www.ema.europa.eu/documents/assessment-report/mvasi-eparpublic- assessment-report_en.pdf
-
-
-
-
332
-
-
85148921661
-
-
www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.47
-
Code of Federal Regulations Title 21 Food and Drugs – Part 312.47 Meetings; www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.47
-
-
-
-
333
-
-
85148915838
-
-
www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070568.pdf
-
FDA Guidance For Industry: IND Meetings For Human Drugs and Biologics – Chemistry, Manufacturing, and Controls Information (May 2001); www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070568.pdf
-
-
-
-
334
-
-
85148921617
-
-
https://www.ema.europa.eu/documents/annualreport/ 2017-annual-report-european-medicines-agency_en.pdf
-
EMA Annual Report 2017 (May 2018); https://www.ema.europa.eu/documents/annualreport/ 2017-annual-report-european-medicines-agency_en.pdf
-
-
-
-
335
-
-
85148920439
-
-
www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ ucm475586.pdf
-
FDA Guidance for Industry and Review Staff – Good Review Practice: Best Practices for Communication Between IND Sponsors and FDA During Drug Development (December 2017); www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ ucm475586.pdf
-
-
-
-
336
-
-
85148915382
-
-
www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf
-
FDA (Draft) Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (December 2017); www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf
-
-
-
-
337
-
-
85148919937
-
-
www.fda.gov/downloads/Drugs/Guidance- ComplianceRegulatoryInformation/Guidances/UCM609662.pdf
-
FDA (Draft) Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products (June 2018); www.fda.gov/downloads/Drugs/Guidance- ComplianceRegulatoryInformation/Guidances/UCM609662.pdf
-
-
-
-
338
-
-
85148922795
-
-
www.fda.gov/downloads/ForIndustry/ UserFees/PrescriptionDrugUserFee/UCM207568.pdf
-
Yetter, R., FDA PDUFA Activities in Drug Development; www.fda.gov/downloads/ForIndustry/ UserFees/PrescriptionDrugUserFee/UCM207568.pdf
-
-
-
-
339
-
-
85148918340
-
-
www.fda.gov/downloads/aboutfda/centersoffices/cder/manualofpoliciesprocedures/ ucm218757.pdf
-
FDA CDER 21st Century Review Process: Desk Reference Guide NDA/BLA Review Process; www.fda.gov/downloads/aboutfda/centersoffices/cder/manualofpoliciesprocedures/ ucm218757.pdf
-
-
-
-
340
-
-
85148916596
-
-
FDA FY2017 Performance Report to Congress for the Prescription Drug User Fee Act (PDUFA); www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/ UserFeeReports/PerformanceReports/UCM606719.pdf
-
-
-
-
341
-
-
85148923108
-
-
www.ema.europa.eu/en/ human-regulatory/research-development/scientific-advice-protocol-assistance
-
EMA Scientific Advice and Protocol Assistance webpage; www.ema.europa.eu/en/ human-regulatory/research-development/scientific-advice-protocol-assistance
-
-
-
-
342
-
-
85148916339
-
-
EMA Guidance for Applicants Seeking Scientific Advice and Protocol Assistance (June 2017); www.ema.europa.eu/documents/regulatory-procedural-guideline/european-medicinesagency- guidance-applicants-seeking-scientific-advice-protocol-assistance_en.pdf
-
-
-
-
343
-
-
85148923984
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Trogarzo (Ibalizumab-uiyk): Approval History, Letters, Reviews and Related Documents – Administration and Correspondence Documents – CMC-Focused Pre-BLA Meeting Minutes (September 04, 2015); www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761065Orig1s000AdminCorres. pdf
-
-
-
-
344
-
-
85148927188
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Kevzara (Sarilumab): Approval History, Letters, Reviews and Related Documents – Administration and Correspondence Documents – CMC-Focused Pre-BLA Meeting Minutes (December 16, 2014); www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761037Orig1s000Admincorres. pdf
-
-
-
-
345
-
-
85148922602
-
-
FDA Drugs – Search Drugs@FDA – FDA Approved Drug Products: Crysvita (Burosumab-twza): Approval History, Letters, Reviews and Related Documents – Administration and Correspondence Documents – Pre-BLA Meeting Minutes (June 19, 2017);www.accessdata. fda.gov/drugsatfda_docs/nda/2018/761068Orig1s000Admincorres.pdf
-
-
-
-
346
-
-
85148926502
-
-
EMA European Public Withdrawal Assessment Report (EPAR): Theraloc (Nimotuzumab) (May 2009);www.ema.europa.eu/docs/en_GB/document_library/Application_withdrawal_ assessment_report/2010/01/WC500063198.pdf
-
-
-
-
347
-
-
85148926890
-
-
EMA European Public Assessment Report (EPAR): Oxervate (Cenegermin, Recombinant Nerve Growth Factor) (May 2017); www.ema.europa.eu/documents/assessment-report/ oxervate-epar-public-assessment-report_en.pdf
-
-
-
|