Representing Hitachi Chemical Advanced Therapeutic Solutions, Alex Klarer spoke to the BPI Theater at BIO on Tuesday, 4 June 2019, about ways to improve patient access to revolutionary T-cell immunotherapies. A feasible solution, Klarer contended, is to develop a form of stirred-batch bioculture that reduces the entire manufacturing process while still maintaining high expansion rates with low media use. To establish this as a possibility, Klarer described his firm’s experiments with small and large batches on a Distek cell culture…

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…

During a BPI Theater at BIO presentation on Wednesday, 5 June 2019, Charles Christy, director of commercial development at Ibex Solutions (Lonza Pharma and Biotech), considered the increasing speed of molecule discovery, process development, and clinical approval in the biopharmaceuticals industry. Weighing the promises and pitfalls of such a volatile, uncertain market, Christy offered drug developers advice about when to build biomanufacturing facilities in-house and when to outsource services. One solution, Christy suggests, is to partner with agile contract development…

Ray Marzouk, vice president of quality at Avid Bioservices, joined the BPI Theater at BIO on Wednesday, 5 June 2019, to call out factors that drug developers often neglect when they are deciding whether to enlist a contract development manufacturing organization (CDMO) for scaling up and introducing new therapies in a competitive market. Citing examples related to ICH Q5d cell banking rules, Marzouk explained how Avid conducts smooth and rapid transfers of key process elements and quality diagnostics. Streamlining that…

In this BPI Theater @ BIO presentation from Tuesday, 4 June 2019, Thomas Page, a vice president of engineering and asset development, explains how Fujifilm Diosynth partners with other organizations to deliver commercial-quality chemistry, manufacturing, and controls (CMC) for complex, next-generation biopharmaceuticals. Rather than simply transacting with clients, Page notes, his firm elects to go beyond standard engineering controls for patient safety and clinical filing. Using a wider array of risk assessments than is typical in the industry enables Fujifilm…