Process Intensification in Animal Cell-based Vaccine Manufacture
The industry is experiencing an acceleration in the development and approval of novel prophylactic and therapeutic vaccine modalities. Concurrently, many biopharmaceuticals are experiencing the benefits of manufacturing process intensification (PI). Describing such advances for cell-culture based processes is challenging in the field of vaccinology because of the number of vaccine types, innovative delivery and adjuvant systems, and production platforms.1 Restricting ourselves to cell-based manufacturing yields a diversity of platforms, from E. coli to yeast to animal cells. Further restriction to only animal cell-based production still includes such distinctions as classical vs single-use, suspension vs. adherent, and fed-batch vs. perfused continuous platforms. Even adherent culture is performed in a variety of formats, including stacked array flasks, roller bottles, and macro- and micro-carrier fabric or beads, as well as moving and fixed-bed bioreactors. So, there is a large and growing number of methods to produce vaccines in the large-scale culture of diverse cell types.