The promise of gene therapy depends greatly on the ability to scale processes from the bench to a highly regulated cGMP manufacturing environment while ensuring the purity, quality, and safety of the final product. At larger scales in particular, the baculovirus expression system in Spodoptera frugiperda Sf9, Sf21 and other insect host cells holds various advantages over other common mammalian expression systems for viral vector production. However, the baculovirus system does have a few host system-specific analytical challenges. Therefore, highly reliable, sensitive analytical assays are critical to demonstrate removal of product or process-related impurities during development, scale-up, and lot-release.
In this webinar, we will compare different viral vector production platforms with a focus on the advantages and specific analytical challenges of the baculovirus expression system in Sf9 cells. You will learn about process analytics and lot-release assay requirements for viral vector-based advanced therapy medicinal products (ATMP). We will share simple solutions for the quantitation of residual DNA and potential Sf-Rhabdovirus contaminants applicable to this expression system at any stage in the development process, in preparation for manufacturing success.