Building A Bridge Of Equivalence To Facilitate And Implement Rapid Process Changes In Gene Therapy Manufacturing

The number of gene therapy candidates in development is growing rapidly, with many advancing toward late-stage trials. The majority of these therapies are based on viral vector delivery. While improvements in manufacturing processes continue, manufacturers remain challenged to quickly implement new technologies for products in late-stage development or that have received approvals. A clear path for establishing equivalency is needed to facilitate more rapid advances in the field and ultimately enable lower-cost gene therapies that reach patients faster than ever.

State of the Gene Therapy Manufacturing Sector

The gene therapy market is currently expanding at approximately 30% annually, based on a review of several recent market research reports. Continued advances in viral vector technologies are enabling safe and efficient delivery of genetic material to a variety of tissues for resolution of genetic deficiencies that lead to many different diseases.