Manufacturing pluripotent cell therapeutics: the importance of quality from the very beginning
Unlike many other forms of cell therapeutics that are tailored for individual patients and rely on small batch production, pluripotent cell therapies for both allogeneic and autologous use have as one of the first steps the establishment of a master cell bank that must last the lifetime of the product. Thus, raw material quality is paramount from the beginning of the development process. Obtaining high-quality raw materials from suppliers experienced in supporting cell therapy development—from manufacturing to delivery—can increase the probability of success and head off costly surprises that could cause an untimely demise for a promising pluripotent cell therapy candidate.
Ben Fryer is the CEO and co-founder of Pluristyx Inc. providing GMP pre-expanded pluripotent stem cells, contract development services, and consultancy for groups and company developing cell and tissue therapies. Ben has almost 25 years of experience as a leader and scientist in large pharma, academia, and start-up companies developing combination products and cell therapies. He has worked to generate GMP/ clinical grade pluripotent stem cells from early banking through large scale expansion using scalable, closed-loop, suspension reactor processes to manufacture cell therapy treatments for diabetes and heart disease.
Ben is an inventor on multiple issued patents and patent applications for BetaLogics/Janssen/ J&J, including a bioreactor based, stem cell suspension expansion and differentiation process and a product currently marketed by Thermo-Fisher(TM) as Nunclon-Vita.
Ben earned his BA from Colorado College, his PhD from UPENN, and studied as a post-doctoral fellow in the Howard Hughes Laboratory of M. Celeste Simon at the University of Pennsylvania investigating the role of Hypoxia Inducible Factor in cancer and stem cell development.