Successful Scaling Of Suspension-Based Viral Vector Production From Process Development To Clinical Manufacture

By Cassie-Marie Peigné, Ph.D., Bioprocess Applications Specialist, Team Leader, Polyplus

The development of robust, scalable, cost-effective processes that yield high titers of high-quality viral vectors will be crucial to the successful commercialization of safe and efficacious gene therapies that require large and/or multiple doses to treat more prevalent diseases. This topic was explored in a panel webinar discussion hosted by Cell & Gene Therapy Insights in which I shared, along with experts in the field from industry and academia, including Dr. Timothy Cripe (Nationwide Children’s Hospital), Lenore Giannunzio (Andelyn Biosciences), thoughts regarding best practices for successful suspension-based viral vector manufacturing scale-up. This blog summarizes the main points that we made with respect to recent developments in viral vector manufacturing, the need for rapid analytical tests for process development, the importance of designing quality into processes from the outset, the value of early and open collaboration with outsourcing partners, and the benefits of planning early for long-term success.