-
1
-
-
78650311821
-
-
International Conference on Harmonization. Q7, GMP guide for active pharmaceutical ingredients. Geneva, Switzerland; 2000 Nov
-
International Conference on Harmonization. Q7, GMP guide for active pharmaceutical ingredients. Geneva, Switzerland; 2000 Nov.
-
-
-
-
2
-
-
78650362457
-
-
ICH. Q8 R1, Pharmaceutical development, Geneva, Switzerland; 2008, Nov
-
ICH. Q8 (R1), Pharmaceutical development, Geneva, Switzerland; 2008, Nov.
-
-
-
-
3
-
-
78650332671
-
-
ICH. Q9, Quality risk management, Geneva, Switzerland; 2005 Nov
-
ICH. Q9, Quality risk management, Geneva, Switzerland; 2005 Nov.
-
-
-
-
4
-
-
78650413767
-
Guidance for industry: BACPACI: Intermediates in drug substance synthesis: Bulk actives postapproval changes: Chemistry, manufacturing, and controls documentation. Rockville, MD
-
US Food and Drug Administration, Feb, Notice 2006 June 1
-
US Food and Drug Administration. Guidance for industry: BACPACI: intermediates in drug substance synthesis: bulk actives postapproval changes: chemistry, manufacturing, and controls documentation. Rockville, MD; 2001 Feb. Withdrawn Fed. Regist. Notice 2006 June 1.
-
(2001)
Withdrawn Fed. Regist
-
-
-
5
-
-
78650372763
-
-
European Commission Enterprise Directorate General, Brussels, Belgium:, Oct
-
European Commission (Enterprise Directorate General). EMA Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part II, Basic Requirements for Active Substances used as Starting Materials. Brussels, Belgium: 2005 Oct.
-
(2005)
EMA Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Part II, Basic Requirements for Active Substances Used as Starting Materials
-
-
-
6
-
-
78650322925
-
Guidelines on mentions in manufacturing/marketing approval application dossiers for pharmaceuticals and others based on revised pharmaceutical affairs law
-
Ministry of Health, Labor, and Welfare. Pharmaceutical and Food Safety Bureau. Tokyo, Japan:, Feb. 10
-
Ministry of Health, Labor, and Welfare. Pharmaceutical and Food Safety Bureau. Guidelines on Mentions in Manufacturing/Marketing Approval Application Dossiers for Pharmaceuticals and Others Based on Revised Pharmaceutical Affairs Law, PFSB/ELD 020001. Tokyo, Japan: 2005 Feb. 10.
-
(2005)
PFSB/ELD 020001
-
-
-
7
-
-
1242316346
-
Qualification of raw materials for biopharmaceutical use
-
Shadle PJ. Qualification of raw materials for biopharmaceutical use. BioPharm Int. 2004;17(2).
-
(2004)
BioPharm Int.
, vol.17
, Issue.2
-
-
Shadle, P.J.1
-
8
-
-
18344416903
-
The use of peptones as medium additives for the production of a recombinant therapeutic protein in high-density perfusion cultures of mammalian cells
-
Heidemann R, Zhang C, Qi H, Rule JL, Rozales C, Park S, Chuppa S, Ray M, Michaels J, Konstantinov K, Naveh D. The use of peptones as medium additives for the production of a recombinant therapeutic protein in high-density perfusion cultures of mammalian cells. Cytotechnol. 2000;32:157-67.
-
(2000)
Cytotechnol
, vol.32
, pp. 157-167
-
-
Heidemann, R.1
Zhang, C.2
Qi, H.3
Rule, J.L.4
Rozales, C.5
Park, S.6
Chuppa, S.7
Ray, M.8
Michaels, J.9
Konstantinov, K.10
Naveh, D.11
-
9
-
-
33750019223
-
Proteomic analysis for the assessment of different lots of fetal bovine serum as a raw material for cell culture, Part IV. Application of proteomics to the manufacture of biological drugs
-
Zheng X, Baker H, Hancock WS, Fawaz F, McCaman M, Pungor E. Proteomic analysis for the assessment of different lots of fetal bovine serum as a raw material for cell culture, Part IV. Application of proteomics to the manufacture of biological drugs. Biotechnol Prog. 2006;22:1294-1300.
-
(2006)
Biotechnol. Prog.
, vol.22
, pp. 1294-1300
-
-
Zheng, X.1
Baker, H.2
Hancock, W.S.3
Fawaz, F.4
McCaman, M.5
Pungor, E.6
-
11
-
-
77950877204
-
Combining near-infrared (NIR) spectroscopy and multivariate data analysis (MVDA) for screening of raw materials used in the cell culture medium for the production of a recombinant therapeutic protein
-
Kirdar AO, Chen G, Rathore AS. Combining near-infrared (NIR) spectroscopy and multivariate data analysis (MVDA) for screening of raw materials used in the cell culture medium for the production of a recombinant therapeutic protein. Biotechnol Prog. 2010;26:527-531.
-
(2010)
Biotechnol. Prog.
, vol.26
, pp. 527-531
-
-
Kirdar, A.O.1
Chen, G.2
Rathore, A.S.3
-
13
-
-
60149106150
-
Quality by Design for pharmaceuticals: Regulatory perspective and approach
-
Rathore AS, Winkle H. Quality by Design for pharmaceuticals: regulatory perspective and approach. Nat Biotechnol. 2009;27:26-34.
-
(2009)
Nat. Biotechnol.
, vol.27
, pp. 26-34
-
-
Rathore, A.S.1
Winkle, H.2
-
14
-
-
68749083515
-
A roadmap for implementation of Quality by Design (QbD) for biotechnology products
-
Rathore AS. A roadmap for implementation of Quality by Design (QbD) for biotechnology products. Trends Biotechnol. 2009;27:546-53.
-
(2009)
Trends Biotechnol.
, vol.27
, pp. 546-553
-
-
Rathore, A.S.1
-
15
-
-
78650391885
-
Determining the effect of raw materials on manufacturingscale cell-culture performance
-
Jun
-
Jain S, Schilling BM, Shukla AA. Determining the effect of raw materials on manufacturingscale cell-culture performance. Bioprocess Int. 2008 Jun; 36-40.
-
(2008)
Bioprocess Int.
, pp. 36-40
-
-
Jain, S.1
Schilling, B.M.2
Shukla, A.A.3
-
16
-
-
77952959156
-
Tracing and control of raw materials sourcing for vaccine manufacturers
-
doi:10.1016/j.biologicals.2010.01.011
-
Peysson LF. Tracing and control of raw materials sourcing for vaccine manufacturers. Biologicals. 2010; doi:10.1016/j.biologicals.2010.01.011.
-
(2010)
Biologicals
-
-
Peysson, L.F.1
-
18
-
-
78650402078
-
-
USP General Chapter <467> Residual Solvents
-
USP General Chapter <467> Residual Solvents.
-
-
-
-
20
-
-
78650339373
-
-
ICH. Q5A R1, Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, Geneva, Switzerland; 1999
-
ICH. Q5A (R1), Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, Geneva, Switzerland; 1999.
-
-
-
-
22
-
-
78650326445
-
-
Filters
-
21 CFR 211.72 Filters. 2009.
-
(2009)
CFR
, vol.21
, pp. 21172
-
-
-
23
-
-
78650350412
-
-
ICH. Q10, Pharmaceutical quality system, Geneva, Switzerland; 2008
-
ICH. Q10, Pharmaceutical quality system, Geneva, Switzerland; 2008.
-
-
-
-
24
-
-
78650351508
-
-
A Guide to Supply Chain Risk management. Pharmaceutical Quality Group. 2010. Available from
-
A Guide to Supply Chain Risk management. Pharmaceutical Quality Group. 2010. Available from: http://www.pqg.org/publications/riskmanagement/index.php
-
-
-
-
25
-
-
77956172892
-
-
ASTM Standard E-2500, 2007, "Standard guide for the Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment", PA
-
ASTM Standard E-2500, 2007, "Standard guide for the Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment" ASTM International, West Conshohocken, PA, 2007. www.astm.org.
-
(2007)
ASTM International, West Conshohocken
-
-
-
26
-
-
84889277364
-
Evolution and integration of Quality by Design and Process Analytical Technology
-
Rathore AS, Mhatre R, editors, Hoboken, NJ: Wiley Interscience
-
Low D, Phillips J. Evolution and integration of Quality by Design and Process Analytical Technology. In Rathore AS, Mhatre R, editors. Quality by Design for biopharmaceuticals. Hoboken, NJ: Wiley Interscience; 2009. 255-86.
-
(2009)
Quality by Design for Biopharmaceuticals
, pp. 255-286
-
-
Low, D.1
Phillips, J.2
|