Mechanistic insights into viral clearance during the chromatography steps in antibody processes by using virus surrogates
Author:
Affiliation:
1. Biologics Development Bristol‐Myers Squibb Devens Massachusetts USA
Publisher
Wiley
Subject
Biotechnology
Link
https://onlinelibrary.wiley.com/doi/pdf/10.1002/btpr.3057
Reference34 articles.
1. International Conference on Harmonization (ICH) Quality Guideline Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin.1998
2. Viral clearance strategies for biopharmaceutical safety;Aranha H;Pharm Technol,2001
3. Characterization of operating parameters for XMuLV inactivation by low pH treatment
4. Use of MMV as a Single Worst-Case Model Virus in Viral Filter Validation Studies
5. Analysis of viral clearance unit operations for monoclonal antibodies
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