Challenges in the Development of Continuous Processes for Vaccines
04th March 2019 | 11AM EST | Danny Vellom of Sanofi Pasteur Biologics, Inc. |BOOK FREE SEAT
The development and application of continuous manufacturing processes for vaccines present both great opportunities as well as significant challenges, both technical and cultural, for the global industry. The key drivers are manufacturing capacity and flexibility, speed to market, and improved quality through the application of Quality-by-Design and Process Analytical Technology (QbD/PAT). Given the diversity of immunogens (toxoids, conjugate and subunit vaccines, live-attenuated and inactivated viruses, VLPs, etc.), and the variety of unique processes currently utilized to produce either single- or multi-component vaccines, it is unlikely that the transition to continuous processing will happen overnight. Additionally, cultural challenges are faced whenever a new mode of operation appears to some as “too different”, especially in a traditionally conservative sector like the developed-world vaccine industry. That said, market forces, global climate change, and Nature’s propensity to fill unoccupied niches with emerging infectious diseases will undoubtedly induce a first round of pioneers to explore this exciting new design space, ultimately leading to a more nimble industry and more and better opportunities for protection for the global population.
Presented By Danny Vellom of Sanofi Pasteur Biologics, Inc.
Danny’s principle role is the pursuit of innovative manufacturing technology through academic and industrial networking and collaborations, including new technologies scouting, assessment, and implementation for all phases of live-viral vaccines process development. He is also often called upon for product & process improvement and troubleshooting for a variety of manufacturing processes across the company. He has been a Lecturer in Oxford University’s Clinical Vaccinology Programme since 2011. Formerly, he was the founder and head of Process Development at Acambis from 2001-2008, responsible for ushering 7 new vaccine candidates through phase-appropriate process development, two of which are now licensed.