Mechanistic insights into viral clearance during the chromatography steps in antibody processes by using virus surrogates

Author:

Dyer Rachel1,Song Yuanli1,Chen Jie1ORCID,Bigelow Elizabeth1,McGinnis Jennifer1,Jenkins Lauren1,Ghose Sanchayita1,Li Zheng Jian1

Affiliation:

1. Biologics Development Bristol‐Myers Squibb Devens Massachusetts USA

Publisher

Wiley

Subject

Biotechnology

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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