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-Reference-Cited by-同舟云学术

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

Published:2021-01-06 Issue:3 Volume:37 Page:
ISSN:8756-7938
Container-title:Biotechnology Progress
language:en
Short-container-title:Biotechnol Progress

Author:

Luo Haibin¹^ORCID,Li Yuling¹,Robbins David¹,Wang Sheau‐Chiann²,Xi Guoling¹,Cox Matthew¹,Nicholson Simone M.³,Wei Chenghong⁴,Pabst Timothy M.¹,Wang William K.¹

Affiliation:

1. Purification Process Sciences, Biopharmaceutical Development Department, Biopharmaceuticals R&D AstraZeneca, One Medimmune Way Gaithersburg Maryland USA

2. Analytical Sciences, Biopharmaceutical Development Department, Biopharmaceuticals R&D AstraZeneca, One Medimmune Way Gaithersburg Maryland USA

3. Safety Science, Biopharmaceutical Development Department, Biopharmaceuticals R&D AstraZeneca, One Medimmune Way Gaithersburg Maryland USA

4. Regulatory Affairs, Biopharmaceutical Development Department, Biopharmaceuticals R&D AstraZeneca, One Medimmune Way Gaithersburg Maryland USA

Publisher

Wiley

Subject

Biotechnology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/btpr.3119

Reference49 articles.

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5. ICH Q3A(R2).Impurities in new drug substances.2006.

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