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

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作者： Luo, Haibin ^[1] ; Li, Yuling ^[2] ; Robbins, David ^[3] ; Wang, Sheau-Chiann ^[4] ; Xi, Guoling ; Cox, Matthew ; Nicholson, Simone M. ; Wei, Chenghong ; Pabst, Timothy M. ; Wang, William K.

作者单位： AstraZeneca, Biopharmaceut Dev Dept, Biopharmaceut R&D, Analyt Sci, One Medimmune Way, Gaithersburg, MD 20878 USA ^[1] AstraZeneca, Biopharmaceut Dev Dept, Biopharmaceut R&D, Safety Sci, One Medimmune Way, Gaithersburg, MD 20878 USA ^[2] AstraZeneca, Biopharmaceut Dev Dept, Biopharmaceut R&D, Regulatory Affairs, One Medimmune Way, Gaithersburg, MD 20878 USA ^[3] AstraZeneca, Biopharmaceut Dev Dept, Biopharmaceut R&D, Purificat Proc Sci, One Medimmune Way, Gaithersburg, MD 20878 USA ^[4]

关键词 process clearance process development process&8208 related impurity risk assessment safety risk management

发布时间 2021-09-07

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