The potential of excipients to improve the efficiency of immuno-oncology therapy.

• Main Author: Shireesh Apte
• Format: Article
• Language: English
• Published: International Pharmaceutical Excipients Council
• Series: Journal of Excipients and Food Chemicals
• Online Access: http://jefc.scholasticahq.com/article/2574-the-potential-of-excipients-to-improve-the-efficiency-of-immuno-oncology-therapy.pdf

The cocktail of substances used in cell culture media to cryopreserve, transfect, grow, expand, fractionate, concentrate, wash and remove impurities from leukapheresis harvested T-cells are functional excipients. Even though most of them are not present in the final product, they nonetheless have the potential – during in vitro manufacture - to determine the subsequent in vivo proliferative capacity, persistance, safety and compositional phenotype of the injected re-engineered T-cells. Thus, while the chimeric antigen receptor and co-stimulatory signaling molecules are necessary for CAR-T cell functionality, they may not be sufficient to achieve this functionality unless manufactured using the right cocktail of functional excipients.