Lessons Learned from Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program-Reference-Cited by-同舟云学术

Lessons Learned from Monoclonal Antibody Applications to the Office of Biotechnology Products Quality by Design Pilot Program

Published:2015 Issue: Volume: Page:17-29
ISSN:2210-7371
Container-title:Quality by Design for Biopharmaceutical Drug Product Development
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Author:

Rellahan Barbara L.,Kozlowski Steven,Swann Patrick

Publisher

Springer New York

Link

http://link.springer.com/content/pdf/10.1007/978-1-4939-2316-8_2

Reference19 articles.

1. AAPS American Association of Pharmaceutical Scientists (2005) FDA-ISPE Conference on Pharmaceutical quality assessment-a science and risk-based CMC approach in the 21st Century. Bethesda, Maryland, 5 Nov 2005

2. Carpenter JF, Randolph TW, Jiskoot W, Crommelin DJ, Middaugh CR, Winter G, Fan YX, Kirshner S, Verthelyi D, Kozlowski S, Clouse KA, Swann PG, Rosenberg A, Cherney B (2009) Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality. J Pharm Sci 98:1201–1205

3. CASSS and ISPE (2009) A-Mab: a case study in bioprocess development. http://www.casss.org/associations/9165/files/A-Mab_Case_Study_Version_2-1.pdf

4. Chen X, Liu YD, Flynn GC (2009) The effect of Fc glycan forms on human IgG2 antibody clearance in humans. Glycobiology 19:240–249

5. Food and Drug Administration (1999) ICH Q6B specifications: test procedures and acceptance criteria for biotechnological/biological products. Fed Regist 64:44928

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