SGVector is helping to address the global shortage in viral vectors

The FDA continues with strong support of Innovation in Development of Gene Therapy Products. The agency anticipates many more approvals in the coming years, as evidenced by the circa 1000 Investigational New Drug applications for ongoing clinical studies in this area. The agency believes this will provide patients and providers with increased therapeutic choices. The growth of innovative research and product development in the field of gene therapy is exciting. These therapies are rapidly becoming a therapeutic reality for an increasing number of patients with a wide range of diseases, including rare genetic disorders and autoimmune diseases.

The FDA is expecting a gene therapy boom. By 2025, the agency expects it will be reviewing and approving about 20 cell and gene therapies annually. There is currently a global shortage of cGMP CDMO capacity for manufacturing viral vectors in support of Gene Therapy.