Planning for Commercial Scale of Cell Therapy and Regenerative Medicine Products, Part 1:Achieving Manufacturability and Managing Cost of Goods

摘要

Much mystique and mystery surround the emerging industries of cell therapy and regenerative medicine. As companies progress toward commercial manufacture with potential game changers (e.g., cures for cancer and diabetes) the industry could be on the verge of significant breakthroughs. However, with no real successes to date, the question is raised: What core attributes are required to achieve commercial success? The tale of Dendreon's struggles highlights how difficult it can be to commercialize evenan approved cell therapy product.