Addressing the Challenges of Scaling Cell Therapies

Cell therapy development programs generate encouraging pre-clinical and clinical results with the promise that these tailored therapeutics can provide a curative rather than maintenance therapy. Therapies are being developed across the spectrum from academic institutions to small and medium biotechs/biopharma as well as large pharma companies which have all invested significantly in the cell and gene therapy (CGT) field. As additional CGT therapies gain approval, specifically in solid tumors and auto-immunity, the addressable patient populations will grow requiring scaled -out/-up commercial manufacturing. Although the CGT field is experiencing significant tailwinds, challenges remain. Cell sourcing has long been considered a pain-point which is potentially compounded with the necessity to develop robust GMP manufacturing processes and appropriate analytical methods.