The measurement and control of high-risk host cell proteins for polysorbate degradation in biologics formulation
Author:
Affiliation:
1. Analytical Research & Development, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA
2. Biologics Process Research & Development, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA
Abstract
Publisher
Oxford University Press (OUP)
Subject
Immunology,Immunology and Allergy
Link
https://academic.oup.com/abt/advance-article-pdf/doi/10.1093/abt/tbac002/42201518/tbac002.pdf
Reference63 articles.
1. Polysorbate degradation in biotherapeutic formulations: identification and discussion of current root causes;Dwivedi;Int J Pharm,2018
2. Polysorbates 20 and 80 used in the formulation of protein biotherapeutics: structure and degradation pathways;Kerwin;J Pharm Sci,2008
3. The degradation of polysorbates 20 and 80 and its potential impact on the stability of biotherapeutics;Kishore;Pharm Res,2011
4. Experience with host cell protein impurities in biopharmaceuticals;Vanderlaan;Biotechnol Prog,2018
5. The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk-based management for their control;Bracewell;Biotechnol Bioeng,2015
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