Expression systems for viral vector production: advantages of the Sf9 Baculovirus system and simple solutions to address its specific analytical challenges
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.
An overview of the Sf9 Baculovirus expression system for gene therapy products
A review of the regulatory guidance for gene therapy products and those relevant to the Sf9 / Baculovirus system in particular
Detailed data and performance specification of an accurate, highly sensitive solution for Sf-Rhabdovirus quantitation in Sf cell lines
Duplex real-time PCR solution for the simultaneous accurate quantitation of Sf9 host cell and baculovirus residual DNA
Yi Fang Lee
R&D Scientist, Thermo Fisher Scientific
Yi Fang joined ThermoFisher Scientific as an RND Scientist since Jan 2020. She has led the development of the ViralSEQ Quantitative Sf-rhabdovirus assay. Her previous work experience was in cancer biology and assay development for circulating tumor cells in a microfluidics-based system. Yi Fang received her PhD education at the Genome Institute of Singapore, majoring in oncogene discovery from transcriptome- wide studies. She has published journals on cancer biology, sequencing and microfluidics systems.
Srinath Kashi Ranganath
Staff Scientist – Field Applications, Thermo Fisher Scientific
Srinath is a Staff Scientist – Field Applications with the Pharma Analytics group at Thermo Fisher Scientific, supporting customers in implementing, optimizing and validating the Pharma Analytics workflows for biomanufacturing processes across various therapeutic modalities. Prior, Srinath served as a Bioassay Scientist and an SME for the development and optimization of assays for residual DNA and other process impurities for 6 years. Srinath has an MS in Pharmaceutical Sciences from Campbell University, NC. His thesis is focused on understanding the expression profile of certain intracellular signaling molecules and how altering their function will affect the downstream cell signaling.