Management of ‘out of specification’ commercial autologous CAR-T cell products
Cell Gene Therapy Insights 2018; 4(11), 1051-1058.
Published: 17 December 2018
2017 witnessed historic regulatory approvals of two chimeric antigen receptor T-cell (CAR-T) products – Kymriah® (Novartis) and Yescarta® (Kite Pharma/Gilead). One year later, these approvals have highlighted some specific post-marketing challenges for this new class of therapies. The purpose of this paper is to discuss ‘out of specification’ (OOS) CAR-T products as a unique post-marketing issue for commercial autologous cell therapies.
Submitted for peer review: Oct 30 2018 Published: Dec 14 2018