With Cell and Gene Therapies, Success and Quality Control Go Hand-in-Hand
While the FDA has approved Abecma, the first CAR-T cell therapy in its class, regulatory approval is just the beginning for cell and gene therapies. Such therapies’ safety and financial viability rest on a robust manufacturing and quality control program with the flexibility to scale up and out. Droplet Digital PCR is a sensitive biopharmaceutical quality control tool, offering absolute quantification of nucleic acids and other molecules in a sample.