To appropriately manufacture a pharmaceutical or biologic specific manufacturing processes, product characteristics, and product testing must be defined in order to ensure that the product is safe, effective and consistent between batches. These activities are known as CMC, chemistry, manufacturing and control.
All stages of the drug development life cycle, after drug discovery involve CMC. During preclinical drug development, the proper analytical methods are validated to monitor the product. Stability testing may be initiated, the physicochemical properties of the product are determined, raw materials are chosen and tested. When the drug development process moves into the clinical stage, further analytical method validation is required, and additional characterization of the drug product is needed. After clinical trials the scale up process must ensure that the larger batches of product are the same and meet the same specifications as the drug tested in the clinical trials. After the manufacturing process is qualified, lot release and in process testing will continue to take place.
In this section of the learning center we explore CMC requirements of different products. Small molecules, large molecules and gene therapy products all have very different requirements, but each share the same purpose, to ensure that the manufacturing process consistently produces a safe and effective product that meets or exceeds the specifications set in the NDA.