Keynote Presentation: The Importance of Manufacturing in Cell and Gene Therapy Development

The number of approved cell and gene therapy products in the United States continues to increase. However, further accelerating progress in the field will depend heavily on advancing manufacturing technologies for these products. In particular, the production of high-quality therapy gene therapy vectors used for very small populations remains quite challenging. The use of process automation, including in-process controls, in a similar manner to that which is now starting to be applied to chimeric antigen receptor T cell production may facilitate the production of gene therapy at notably reduced cost compared with current gene therapy manufacturing technologies. Application of such manufacturing technology could be transformational in facilitating the delivery of gene therapy to those in need.