Cell and Gene Therapy

Cell & Gene Therapy Development & Production

Cell  and Gene Therapy products manufacturing focuses on various strategies like the manufacturing process must protect the product, patient, should focus on product characterization, process control, high throughput and parallel processing to achieve scale. The process/analytical development throughout clinical trials involve ongoing, iterative development of manufacturing process and characterization of profile and FDA expecting increasing control and characterization as clinical development progresses. Steps involved in individualized manufacturing and running in parallel for high throughput involves cell selection, expansion, activation, centrifugation and cryopreservation.