Biologics drug product manufacture
Drug product manufacturing encompasses a number of activities including selection and qualification of the right primary packaging, manufacturing of non-GMP drug product batches for toxicological and stability studies, in addition to GMP batches for clinical and commercial supply of different biologic modalities (including highly potent molecules). Our experienced team can execute technology transfers with a focus on details to ensure success, as well as doing time-critical root cause investigations as part of deviation management. There is a lot more to drug product manufacture than filling vials, syringes and devices. Our extensive drug product capabilities include selection and qualification of the right primary packaging.