Development and scale-up of suspension culture processes for viral vector manufacturing: challenges and considerations
Cell & Gene Therapy Insights 2020; 6(1), 149-157
Viral vectors are currently the preferred vehicle for delivery of DNA for cell and gene therapies, which have the potential to revolutionize the treatment of human diseases. Developing high yielding, robust, scalable and commercially viable processes to manufacture sufficient quantities of viral vectors that also meet the stringent standards of purity, identity, potency and safety presents challenges. This article will discuss some of these challenges and considerations for the development of viral vector production processes. We conclude that although the industry will see a variety of production technologies employed for the manufacture of viral vectors, suspension culture will become the predominant method of production due to its scalability and it likely being the only method able to generate sufficient quantities of product at commercial scale. We also anticipate that the industry will move away from using transient transfection-based processes and move towards stable producer lines in common with conventional biologics manufacture.