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Volumn 22, Issue 11, 2009, Pages 26-36

Quality by design for biotechnology products: The quality by design working group of the PhRMA biologies and biotechnology leadership committee

(22)  Arora, Taruna a   Greene, Roger a   Mercer, Jennifer a   Tsang, Paul a   Casais, Meg b   Feldman, Stuart b   Look, Jutta c   Lubiniecki, Tony d   Mezzatesta, Joseph e   Pluschkell, Stefanie f   Rosolowsky, Mark g   Rathore, Anurag h   Schenerman, Mark b   Schofield, Tim i   Sheridan, Samantha j   Smock, Paul k   Anliker, Sally l   Atkins, Lois l   McGarvey, Bernerd l   Meiklejohn, Bruce l   more..


Author keywords

[No Author keywords available]

Indexed keywords

CELL PROTEIN; MONOCLONAL ANTIBODY; PROTEIN DERIVATIVE;

EID: 77951640641     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review
Times cited : (9)

References (22)
  • 1
    • 77951650496 scopus 로고    scopus 로고
    • International Conference on Harmonization. Q8(R2), Pharmaceutical development. Geneva, Switzerland Aug
    • International Conference on Harmonization. Q8(R2), Pharmaceutical development. Geneva, Switzerland. 2009 Aug.
    • (2009)
  • 2
    • 77951631411 scopus 로고    scopus 로고
    • US Food and Drug Administration. Guidance for industry: Q9 Quality risk management. Bethesda MD
    • US Food and Drug Administration. Guidance for industry: Q9 Quality risk management. Bethesda, MD; 2006.
    • (2006)
  • 3
    • 77951641506 scopus 로고    scopus 로고
    • US FDA. Guidance for Industry: Q10 Quality systems approach to pharmaceutical CGMP regulations. Bethesda MD
    • US FDA. Guidance for Industry: Q10 Quality systems approach to pharmaceutical CGMP regulations. Bethesda, MD; 2006.
    • (2006)
  • 4
    • 77951643689 scopus 로고    scopus 로고
    • US FDA. Guidance for industry Sept PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance
    • US FDA. Guidance for industry: PAT-A framework for innovative pharmaceutical development, manufacturing, and quality assurance. 2004 Sept.
    • (2004)
  • 5
    • 27144532832 scopus 로고    scopus 로고
    • Human antibodies from transgenic animals
    • Lonesberg IN. Human antibodies from transgenic animals. Nature Biotech. 2005;23:l:117-125.
    • (2005) Nature Biotech. , vol.23 , Issue.1 , pp. 117-125
    • Lonesberg, N.1
  • 7
    • 33846215917 scopus 로고    scopus 로고
    • Antibody constructs in cancer therapy; Protein engineering strategies to improve exposure in solid tumors
    • Beckman RA, Weiner LM, Davis HM. Antibody constructs in cancer therapy; protein engineering strategies to improve exposure in solid tumors. Cancer. 2007;109(2):170-179
    • (2007) Cancer , vol.109 , Issue.2 , pp. 170-179
    • Beckman, R.A.1    Weiner, L.M.2    Davis, H.M.3
  • 8
    • 34748865088 scopus 로고    scopus 로고
    • Antibodies therapeutics:Isotype and glycoform selection
    • Ravetch J. Antibodies therapeutics:isotype and glycoform selection. Expert opin biol ther. 2007; 7(9):1401-1413
    • (2007) Expert Opin Biol Ther. , vol.7 , Issue.9 , pp. 1401-1413
    • Ravetch, J.1
  • 10
    • 38449112154 scopus 로고    scopus 로고
    • Engineering antibodies for stability and efficient folding
    • Honegger A. Engineering antibodies for stability and efficient folding. Handb Exp Pharmacol. 2008;181:47-68.
    • (2008) Handb Exp Pharmacol. , vol.181 , pp. 47-68
    • Honegger, A.1
  • 11
    • 60149106150 scopus 로고    scopus 로고
    • Quality by Design for Pharmaceuticals: Regulatory perspective and approach
    • Rathore AR, Winkle H. Quality by Design for Pharmaceuticals: Regulatory perspective and approach. Nature Biotechnol. 2009. 27(1):26-34.
    • (2009) Nature Biotechnol. , vol.27 , Issue.1 , pp. 26-34
    • Rathore, A.R.1    Winkle, H.2
  • 12
    • 34447642317 scopus 로고    scopus 로고
    • Validation and implementation of drug-dependent antibody assays in clinical trials for safety monitoring of patients dosed with roxifiban, an orally bioavailable glycoprotein IIb/IIIa antagonist
    • DOI 10.1016/j.jpba.2007.03.030, PII S0731708507002002
    • Barrett YC, Ebling W, Pieniaszek H, Billheimer J, Seiffert D. Validation and implementation of drug-dependent antibody assays in clinical trials for safety monitoring of patients dosed with roxifiban, an orally bioavailable glycoprotein llb/llla antagonist. J Pharm Biomed Anal. 2007 Aug 15;44(4):938-946 (Pubitemid 47095191)
    • (2007) Journal of Pharmaceutical and Biomedical Analysis , vol.44 , Issue.4 , pp. 938-946
    • Barrett, Y.C.1    Ebling, W.2    Pieniaszek, H.3    Billheimer, J.4    Seiffert, D.5
  • 13
    • 35848955440 scopus 로고    scopus 로고
    • Application of analytical detection concepts to immunogenicity testing
    • DOI 10.1021/ac071364d
    • Klakamp SL, Lu H, Tabrizi M, Funelas C, Roskos LK, Coleman D. Application of analytical detection concepts to immunogenicity testing. Anal Chem. 2007 Nov l;79(21):8,176-184 (Pubitemid 350060015)
    • (2007) Analytical Chemistry , vol.79 , Issue.21 , pp. 8176-8184
    • Klakamp, S.L.1    Lu, H.2    Tabrizi, M.3    Funelas, C.4    Roskos, L.K.5    Coleman, D.6
  • 18
    • 45149110911 scopus 로고    scopus 로고
    • Defining process design space for biotech products: Case study of Pichia pastoris fermentation
    • DOI 10.1021/bp070338y
    • Harms J, Wang X, Kim T, Yang J, Rathore AS. Defining design space for biotech products: Case study of Pichia pastoris fermentation. Biotechnol Prog. 2008:24(3):655-662 (Pubitemid 351832721)
    • (2008) Biotechnology Progress , vol.24 , Issue.3 , pp. 655-662
    • Harms, J.1    Wang, X.2    Kim, T.3    Yang, X.4    Rathore, A.S.5
  • 21
    • 77951623849 scopus 로고    scopus 로고
    • Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products Federal Register. July 2
    • Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Pilot Program. Federal Register. July 2 2008;73(128):37972-37974
    • (2008) Notice of Pilot Program. , vol.73 , Issue.128 , pp. 37972-37974
  • 22
    • 77951630111 scopus 로고    scopus 로고
    • Parenteral Drug Association. PDA Technical Report 42. Bethesda MD: PDA; Sept
    • Parenteral Drug Association. PDA Technical Report 42. Process Validation of Protein Manufacturing. Bethesda, MD: PDA; Sept 2005;59(S-4):1-28.
    • (2005) Process Validation of Protein Manufacturing , vol.59 , Issue.4 S , pp. 1-28


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.