A systematic approach to the validation of monoclonal antibody manufacturing processes-Reference-Cited by-同舟云学术

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A systematic approach to the validation of monoclonal antibody manufacturing processes

Published:1998-10 Issue:7 Volume:1 Page:300-308
ISSN:1461-5347
Container-title:Pharmaceutical Science & Technology Today
language:en
Short-container-title:Pharmaceutical Science & Technology Today

Author:

Knaack Christian A,Hawrylechko Anthony M.J

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference43 articles.

1. CBER, FDA (1997) Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use

2. ICH Expert Working Group (1997) Viral Safety Evaluation of Biotechnology Products

3. CPMP Biotechnology Working Group (1996) Note for Guidance on Virus Validation Studies: the Design, Contribution, and Interpretation of Studies Validating the Inactivation and Removal of Viruses

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2. Model based robustness analysis of an ion-exchange chromatography step;Journal of Chromatography A;2007-01

3. Constrained optimization of a preparative ion-exchange step for antibody purification;Journal of Chromatography A;2006-04

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5. Using computer simulation to assist in the robustness analysis of an ion-exchange chromatography step;Journal of Chromatography A;2005-01

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