BESPOKE CELL THERAPY MANUFACTURING PLATFORMS - A CONTRADICTION IN TERMS?

摘要

Advanced biological therapies, such as cell and viral therapeutics, will have a transformative effect on healthcare. In many cases these therapies are curative rather than palliative and aim to treat a wide range of diseases including malignancies, cardiovascular, immune, and metabolic disorders. As cell therapies begin to enter commercialization stages, some of the bigger challenges that need to be addressed include bottlenecks in production and high cost of goods. At the same time, switching to manufacturing platforms that might allow scale-up (allogeneic) and scale-out (autologous) to allow commercialization at an acceptable cost of goods could result in changes to the cell product critical quality attributes.