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...

Descripción completa

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

Ejemplares similares

Ejemplares similares