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 selectively target and destroy cancer cells while sparing healthy tissue, hold immense potential to transform conventional cancer treatment. These engineered viruses offer a promising alternative or complement to existing therapies, leveraging their ability to replicate within tumors and stimulate an immune response. However, despite their promise, the widespread clinical adoption of oncolytic viruses depends on overcoming critical challenges related to safety, efficacy, and large-scale manufacturing. Researchers continue to refine these viruses through advanced viral engineering techniques, but their successful development requires meeting key objectives, including achieving high virus yields, ensuring the reproducibility of critical quality attributes, maintaining genetic stability, and optimizing formulation and product stability. The commercial landscape for oncolytic viral therapies remains relatively nascent, with the first FDA-approved oncolytic virus entering the market in 2015. This limited history has resulted in a shortage of specialized expertise in oncolytic virus design and production. As biopharmaceutical companies increasingly recognize the potential of these therapies, the demand for contract development and manufacturing organizations (CDMOs) with experience in viral vector engineering — particularly in the design, optimization, and scalable production of oncolytic viruses — has never been more pressing. Establishing robust manufacturing capabilities and expertise in this field will be essential to advancing the next generation of oncolytic viral therapies and realizing their full clinical and commercial potential.