GMP Manufacturing of Oncolytic Viruses: Critical Steps and Key Considerations

Deep Dive
Published: 15 October 2021 Author: Kai Lipinski, PhD, CSO

The oncolytic virus (OV) sector needs to overcome several challenges to bring transformative cancer therapeutics to the clinic.  

Not only are there production, formulation, and product stability issues to contend with, but challenges with developing and validating quality control release and biological potency assays as well. Moreover large, non-filterable viruses require full aseptic processing and validation executed in grade A/B cleanrooms. 

Specialized know-how in OV manufacturing, chemistry, manufacturing and controls (CMC) and regulations, as well as other attributes is needed to bring challenging OV products successfully to the clinic and market.  

In our latest edition of Virotherapy Insider: Deep Dive, we will discuss the critical steps involved in OV development, manufacturing and testing. We will also explore the measures that need to be taken at each stage to ensure success.   

In part 2, you will learn about key factors to consider, including: 

  • Cell line selection 
  • Choice of cell-culture platform  
  • Virus rescue and cloning considerations 
  • GMP seed material generation 
  • Process and analytical development 

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