総説
MCB/WCBとその規制の歴史と現状
2023 年 25 巻 2 号 p. 20-26
詳細
2023 年 25 巻 2 号 p. 20-26
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.
