Safety risk management for low molecular weight process‐related impurities in monoclonal antibody therapeutics: Categorization, risk assessment, testing strategy, and process development with leveraging clearance potential

Process‐related impurities (PRIs) derived from manufacturing process should be minimized in final drug product. ICH Q3A provides a regulatory road map for PRIs but excludes biologic drugs like monoclonal antibodies (mAbs) that contain biological PRIs (e.g. host cell proteins and DNA) and low molecul...

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Detalles Bibliográficos
Autores principales: Luo, Haibin, Li, Yuling, Robbins, David, Wang, Sheau‐Chiann, Xi, Guoling, Cox, Matthew, Nicholson, Simone M., Wei, Chenghong, Pabst, Timothy M., Wang, William K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2021
Materias:
RESEARCH ARTICLES
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8365748/
https://www.ncbi.nlm.nih.gov/pubmed/33373106
http://dx.doi.org/10.1002/btpr.3119

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8365748/
https://www.ncbi.nlm.nih.gov/pubmed/33373106
http://dx.doi.org/10.1002/btpr.3119

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