Post-approval CMC submissions and regulatory considerations for autologous CAR-T cell products
WANG Jing-yu
WANG Xue
LU Jia-qi
WEI Wei
Abstract：Autologous chimeric antigen receptor T cell(CAR-T)therapies have emerged as a prominent area for biopharmaceutical development and regulatory submissions in recent years.Their complex,patient-specific manufacturing and the still-accumulating clinical and commercial experience present substantial challenges in managing post-approval chemistry,manufacturing,and controls(CMC)changes.Drawing on recent submission and review experiences for licensed autologous CAR-T cell products,this article discusses common post-approval CMC topics.These include changes to the CAR-T cell manufacturing process,viral vector manufacturing process,specifications,raw materials,drug product shelf-life,and container closure&storage conditions.The paper aims to explore recommended study approaches and key regulatory considerations for these changes,with the goal of providing guidance to industry sponsors.
Keywords：autologous chimeric antigen receptor T cell productspost-approval chemistrymanufacturingand controls changesstudy approachregulatory considerations
Publication Date：2025-12-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2629-2634 )