Robert Schlegl

Purification and Formulation: Silent but Important Players in Vaccine Development

This chapter covers postproduction and postfermentation processes, which ensure the purity, stability, and structural integrity of a vaccine. First, it illustrates downstream processing methods and unit operations, like centrifugation, filtration, precipitation, and chromatographic techniques, with special attention to the specific features of respective vaccine types. These issues are addressed through an explanation of the principal physicochemical driving forces behind each technique as well as an introduction to basic biochemical engineering principles and modeling approaches. A subchapter describes exemplary purification sequences for each type of vaccine. The second focus includes formulation development covering the main types of degradation pathways, physical and chemical, and techniques for analyzing and monitoring these degradations. Finally, the actual formulation is covered, including different methods and additives that ensure vaccine stability.