Challenges And Solutions For Viral Product Development And Manufacturing

By Todd Ranheim – Advanced Analytics Core, and Joseph Shultz -Technical Head – Biologics & Vaccines, Resilience

The proliferation of recombinant protein therapies has driven the need for new capacity in the biotherapeutic manufacturing space. Monoclonal antibodies (mAbs), high-value products that require large volumes of material, are one such modality that has motivated a surge in capacity. Many large contract development and manufacturing organizations (CDMOs) are standing up new equipment and facilities to meet the demand for these products.

Additionally, the potential for viruses and viral vectors to address rare and intractable diseases makes them an essential modality for the future of the vaccine, cell, and gene therapy fields. However, developers of live virus, attenuated live virus, oncolytic virus, or viral vectors, have narrow partnering options for manufacturing. This is largely due to the complexity and diversity of these viral products and the bespoke nature of their production. For some of these viral products, the platform technologies and suspension culture approaches that have enabled scale for mAb manufacturing are impractical or unavailable. A service provider with the ability and capacity to execute such complex manufacturing requires expertise in suspension and adherent cell culture capabilities, cell line productivity, and a deep understanding of the intricacies that can attend to manufacture these products.