Toward an integrated model of product characterization for CAR-T cell therapy drug development efforts

In by

Spotlight Article

Expert Insight

Sadik H Kassim

Latest advances in CAR-T cell manufacturing

Chimeric antigen receptor T (CAR-T) cell therapies have produced remarkable clinical outcomes in relapse/refractory cancer patients. These therapies have also led, in certain cases, to life-threatening side effects. The field is now at a critical juncture where a number of CAR-T cell therapies have completed pivotal trials and are on the path to global registration. However, little is known about how to characterize these ‘living’ drug products before administration and more needs to be understood about how different manufacturing strategies can affect safety and efficacy. Moreover, the interplay between the CAR-T cell therapy drug product and the host-specific microenvironment remains incompletely understood. This brief article will review some of the most common analytical challenges encountered during CAR-T cell therapy drug product development and will propose an integrated analytical characterization strategy that may enable for the rapid and comprehensive development of safer and more effective CAR-T therapies.

Submitted for review: Mar 6 2017 Published: May 4 2017
DOI: 10.18609/cgti.2017.026
Citation: Cell Gene Therapy Insights 2017;3(4), 227-237.
Open access

This content is restricted to registered users. Click here to Register or Login here.