PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
Review
History and current status of MCB/WCB regulations
Norio YANAGISAWA
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Keywords: Master cell bank, working cell bank, ATMPs, regulations, history of regulations, PIC/S Annex 2
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2023 Volume 25 Issue 2 Pages 20-26

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Abstract

In this review, MCB/WCB, which is an extremely important cell group for producing ATMPs, was briefly explained. Then, the regulations (GMP) that have evolved since the Kefauver-Harris Amendments have considered what kind of demands they have made on MCBs/WCBs, and the reasons for them.

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© 2023 Parenteral Drug Association Japan Chapter
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