Challenges and Processes for Development and Scale-up of Stem Cell Therapies

GMP cell manufacturing for new clinical cell therapies is a rapidly expanding need in the life science space. This presentation will discuss the foundation of cell therapy product development considerations when preparing to launch into manufacture of materials in support of early Phase clinical trials to commercialization. Historical development of an autologous canine mesenchymal stem-cell product that facilitated the ability to rapidly respond to develop and manufacture an allogeneic human MSC product for treatment of COVID-19 patients with ARDS will be presented. Learning Objectives: - MSC isolation from tissue to success in primary cell culture - Characterization of cell lines - Avoiding development pitfalls in the scale-up of cell therapy manufacturing Speaker: Carolyn Wrightson, Ph.D. Chief of Operations VetStem Biopharma Austin Mogen, Ph.D. Senior Field Application Scientist Corning Incorporated | Life Science