NIST BMD/IBBR Seminar: Standardized AAV and LVV Viral Vector and Plasmid Manufacturing and Analytics

Scalability and affordability are two of the main prominent challenges for the AAV and lentivirus-based cell and gene therapy supply.  To meet the need for increased viral vector manufacturing, we propose to establish standardized AAV and lenvirus vector and plasmid manufacturing and analytics to ensure consistency of the productivity and to accelerate the release of GMP materials. Transfection efficiency, selection of producer cells, upstream production and downstream purification by chromatography as well as packaging plasmid manufacturing will be discussed. In addition, the newly launched AAV reference standards for AAV testing and analytics and their application for the standardized AAV testing will be overviewed.