Streamline The AAV Manufacturing Process With High-Grade Starting Materials

By Rachael Hardison, Ph.D., Manager, Technical Sales, Forge Biologics, and Don Belcher, Scientist II, Process Development, Forge Biologics

Plasmid DNA is one of the most common starting points for manufacturing recombinant adeno-associated virus (rAAV) vectors. As a gene therapy developer, carefully considering the manufacture and testing of plasmids is prudent for laying the groundwork for AAV manufacturing. Gene therapy developers need a depth of knowledge around the critical quality attributes of both plasmid DNA and the finished rAAV gene therapy product.

This article explores:

• Plasmid DNA Quality Characteristics to Consider in AAV Manufacturing
• Navigating the Path from Discovery to BLA with a Phased-Approach to Plasmid DNA 
• Analytical Considerations When Generating Plasmid DNA for AAV Gene Therapies