A survey of FDA Approved Monoclonal Antibodies and Fc-fusion Proteins for Manufacturing Changes and Comparability Assessment.

Zhe LiXiulian DuYow-Ming C Wang

Published in: Pharmaceutical research (2023)

Our comprehensive retrospective analysis provides an understanding of the regulatory experience and industry practice, which could facilitate developing appropriate comparability approaches to support manufacturing changes in the future.

Keyphrases

primary care
healthcare
current status
transcription factor
drug administration