BioInsights - Considerations for the development of autologous CAR-T cell products

Considerations for the development of autologous CAR-T cell products

Cell & Gene Therapy Insights 2021; 7(11), 1685–1696

10.18609/cgti.2021.217

Published: 11 January 2022
Expert Insight
Alexander Davidson, Gerardo Santiago Toledo, Kostadinka Lilova, Michael Merges, Peter Jones

Successful clinical outcomes for cancer patients are leading to significant investment flowing into a wave of novel innovative CAR-T cell products currently under clinical development. Although initial drug approvals have been relatively small to date, the significant pipeline of CAR-T cell therapies currently underway will significantly expand the impact of these treatments, and unleash their genuine, unprecedented potential. These personalized therapies, however, pose unique challenges for manufacturing and commercial scale-up/out. From our perspective, we will address here some of the key challenges to establish an effective process for clinical manufacturing and beyond, namely the patient starting material (leukapheresate), the increasing commercial availability of flexible closed manufacturing platforms for autologous therapies, analytical method development, the suitability of critical raw materials and reagents as well as vector supply.