Platform technologies are used extensively across the biopharmaceutical industry to develop drugs efficiently and effectively. The application of prior knowledge and platforms from established products lays a strong foundation to guide development and advance new medicines to the patients. From cell line development, upstream and downstream operations, formulation development, devices, and analytical methodologies, platforms have proven that they work and are a powerful tool. However, there are no universal standards on how to create, justify and maintain platforms. The inclusion of platform information and the level of detail in the dossier is key for regulatory agencies to evaluate the applicability of the platform using a risk-based assessment. Moreover, the rationale and justification on how prior knowledge and platform data are suitable for the intended product is essential in a review. This session will look at the application of platform approaches and technologies and how they can be applied to programs to support development and registration. Insight into how prior knowledge for a platform is fully leverage across products and supporting rationale will be presented in case studies. The objective from the session should help developers and health authorities better align on expectations and paths to use platforms for clinical development through commercialization.

Jason Starkey

Appearances

CASSS Welcome and CMC Strategy Forum 2024 Introductory Comments

Session Chairs