Fast Single-Use VLP Vaccine Productions Based on Insect Cells and the Baculovirus Expression Vector System: Influenza as Case Study

During the last few years virus like particles (VLPs) have become increasingly interesting for the production of vaccines. This development is explained by their excellent safety profile as well as a significant number of clinical studies showing strong and long-lasting protection. A further reason is the possibility of speeding up VLP vaccine manufacturing by implementing single-use (SU) technology in the case of mammalian and insect-cell-based processes, for which a multitude of SU devices up to middle-volume scale already exist. After briefly introducing the vaccine types and expression systems currently in use, this chapter turns to VLP vaccines and the insect cell/baculovirus expression vector system (IC/BEVS). Based on the main process characteristics and typical process flow of IC/BEVS-based VLP vaccine productions, suitable SU devices and their implementation are addressed. We subsequently report on the successful development of a fast, scalable benchtop production process generating a four-protein component influenza A H1N1 VLP vaccine candidate. This process is based on Spodoptera frugiperda (Sf)-9 cells and combines Redbiotec's rePAX (TM) technology with obtainable SU devices for upstream (USP) and downstream processing (DSP).