Challenges in the cGMP Manufacturing of hESCs: Lessons Learned From Monoclonal Antibodies
Commercialization of hESC-derived therapies will require the development of appropriate policies, procedures, and processes to address the large-scale GMP manufacturing, quality, and regulatory challenges of successfully bringing these new products to market. This presentation will discuss the parallels between hurdles faced today in the manufacture of cell therapy products with those faced by the biotechnology industry in the early days of monoclonal antibody protein production. As with the manufacture of monoclonal antibodies, the establishment of platform processes for the manufacture of hESC products and the adoption of single-use technologies for their production will enable companies to develop reliable, robust, and economically viable manufacturing processes for these products. Using estimates for the anticipated patient populations, dosages, and market penetration of hESC-derived therapies currently under development, it is clear that the scale of production required for these products fits nicely within the realm of current manufacturing technologies.