A Strategy To Remove Formulation Development From The Critical Path During Biologics Development

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. Also, formulation development is often on the critical path to successful IND and BLA fillings. During this Q&A, Dr. Jun Lu, Director, Analytical Development, discusses how Catalent Biologics utilizes automation, specifically the Uncle platform, during formulation development.