Materialization Characterization and Formulation Development

Materialization Characterization and Formulation Development
Expertise in CMC (chemistry, manufacturing, and control) ensures the appropriate manufacture of a pharmaceutical or biologic by coordinating material characterization, formulation development, and product testing for batch safety, consistency, and efficacy.
Materials characterization is a cornerstone in the understanding of the composition of a drug substance or product and its potential for efficacy or adverse biological effects when consumed.
Image Credit: DSI, a PLG Company
CMC is involved during the entire drug development process. Throughout preclinical stages, analytical methods are prepared for product monitoring. Stability testing commences, and the drug’s physicochemical properties are established. Selection and testing of the raw materials also take place.