Common deficiencies of CMC dossiers for new drug applications of autologous CAR-T cell therapy medicinal products and key points to consider in review process
HAN Dong-mei
CUI Jing
WEI Wei
Abstract：The new drug applications for autologous chimeric antigen receptor T-cell immunotherapy(CAR-T)cell therapy medicinal products(CTMPs)increase continually,however,the Chemistry,Manufacturing and Control(CMC)dossiers are generally incomplete and non-standard,which influences the efficiency of review and marketing process to a certain extent.Based on the experience of CMC review for several autologous CAR-T CTMPs,this article summarizes the common deficiencies of CMC dossiers and review considerations,in order to provide some references for the development and application of such products and speed up the new drug applications process.
Keywords：cell therapy medicinal productsnew drug applicationCMC review
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 619-624 )