Overcoming The Raw Material Hurdle: Plasmids For Viral Vector-Based Gene Therapies

By Thomas VanCott, Ph.D., Global Head of Product Development, Catalent Cell & Gene Therapy

The emerging field of cell and gene therapy is transforming today’s industry by bringing new hope to patients suffering from a wide range of serious and life-threatening diseases. The success of using viral vectors to deliver a molecular payload into a cell or replace defective genes with functional ones is an inflection point in the future of modern medicine. Since the landmark approval of Novartis’ KYMRIAH^® in 2017, nearly 20 cell and gene therapies have made it to market.¹ Their success, combined with the overall potential of these groundbreaking products has led to expectations by the FDA that the agency will be approving 10 to 20 cell and gene therapy products a year by 2025.²

However, there are several barriers that could delay a commercial upswing for cell and gene therapies, with a key factor being a shortage of critical raw materials. Pharma and biotech companies have converged on CDMOs to fulfill this gap in the market, but with only a limited number possessing the capability and expertise to meet demand, the result is significant capacity constraints and long lead times. Therefore, when evaluating potential partners, choose one that is expanding its offerings and investing in new technology and additional capacity to address market growth, as they will be best suited to support your product now and well into the future.