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.