A Strategy to Remove Formulation Development from the Critical Path
Summary: Biopharmaceuticals tend to be highly unstable. Therefore, as the product development program progresses to phase 3 clinical stage, formulation development is required to ensure drug product quality and stability during manufacturing, storage, and clinical administration. During this Q&A, Dr. Jun Lu, Director, Analytical Development at Catalent discusses how Catalent utilizes automation, specifically the UNcle® platform*, during formulation development.
The UNcle® Platform is a registered trademark of Unchained Labs.