The National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) and Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are co-hosting a Workshop on Expanding AAV Manufacturing Capacity for Rare Disease Gene Therapies.

Current adeno-associated virus (AAV) manufacturing capacity cannot keep pace with the demand for AAV gene therapy clinical trials. The purpose of the meeting is to bring together thought leaders, key stakeholders and innovators to explore obstacles and identify opportunities for expanding the capacity of AAV manufacturing for rare disease gene therapies. 
Workshop sessions will explore:

  • Prominent manufacturing formats and technologies
  • Major logistical bottlenecks
  • Strategies to streamline scale transitions
  • Master file best practices and opportunities
  • Analytics and lot release testing
  • Prospects for innovation, and barriers to innovation
U.S. Department of Health and Human Services National Center for Advancing Translational Sciences Food and Drug Administration