Process Development of a Closed CAR-T Manufacturing Process

Representing GE Healthcare, Rohin Iyer joined BPI Theater at BIO on Tuesday, 4 June 2019, to explore how academic and clinical drug sponsors could partner with service providers to develop bioprocesses more akin to those in the industry at large. Iyer chronicled GE’s collaboration with the non-profit Center for Commercialization of Regenerative Medicine (CCRM), a public–private partnership in which a team of 105 people (both GE Healthcare and CCRM employees) work together at one location. Elaborating this example, Iyer pointed out that contract development manufacturing organizations (CDMOs) offer sponsors opportunities not only to scale up production but also to increase patient safety because these firms can provide stronger automation capabilities and quality controls. By better collaborating with CDMOs, Iyer suggests, academic and clinical sponsors can control production costs and decrease the financial burdens imposed on patients.