Our Drug Product Service experts manufacture GMP liquid and lyophilized drug product batches for clinical and commercial supplies, as well as non-GMP batches for toxicological and, stability studies, in addition to reference standards. This encompasses a variety of molecules including peptides and proteins, oligonucleotides, and highly potent compounds such as ADCs.
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 as well as GMP batches for clinical and commercial supply of different biologic modalities such as highly potent molecules. Additionally, 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.