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Learning Curve: Challenges in the cGMP Manufacturing of Cell Therapies

By: Susan Dana Jones, Ph.D., Howard L. Levine, Ph.D., and Susan McKee
Reprinted with permission of European Biopharmaceutical Review, January 2012

Commercialization of cell 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 article discusses 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 cell therapies 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.