Director Merck & Co., Inc. West Point, Pennsylvania
The intent of this presentation is to give an introduction and broad overview of the role process development plays in the end-to-end life cycle of a vaccine. A focus will be to explain how process development is situated between discovery and commercialization phases. Emphasis will be placed on the close interactions required between upstream, downstream, analytical, and formulation functions in order to maximize probability of success. Complexity of vaccine development relative to small molecule or therapeutic biologics will also be introduced, particularly with regard to the lack of established platform processes for vaccines.
Upon completion, participant will be able to understand the role that process development plays in transitioning a vaccine candidate from the discovery phase to clinical evaluation and commercialization.
Upon completion, participant will be able to identify the key components and critical interdependencies (e.g., analytical, forrmulation) involved in process development.
Upon completion, participant will be able to realize some of the differences inherent in vaccine development versus small molecules and therapeutic biologics.