Best Practices For Oncolytic Virus Design, Development, And Manufacturing

By Trevor Broadt, Director of Analytical Development and Quality Control, and Heidi Trusheim, Director of Process Development, IDT Biologika

Oncolytic viruses, which exclusively target and break down cancer cells, have the potential to revolutionize standard cancer treatment. Though researchers are continuing to pursue the optimization of these viruses and their manufacture through a variety of viral engineering strategies, their continued progress hinges on meeting a number of goals linked to safety, efficacy, and commercial scale-up. These include high virus yields, highly reproducible key quality attributes, genetic stability, and formulation and product stability goals.

The relatively short history of commercial success linked to oncolytic viral therapies – the first oncolytic to receive FDA approval was in 2015 – has meant a concomitant dearth of expertise in the field of oncolytic viral design. As biopharmaceutical manufacturers begin to explore the potential of these therapies more widely, the need for contract development and manufacturing organizations (CDMOs) with experience in viral vector design, including oncolytic viral design, has become more relevant than ever.