Current Challenges and Our Approaches to Developing Best-in-Class rAAV Manufacturing Processes for Large-scale GMP production.
Time: May 18, Thursday, 2:30pm-3:00pm
Address: Room 511 Exhibitor Showcase, visit us at booth 462
Speaker: Dr. Berenice Carrillo, Associate Director, Downstream Process & Analytical Development
Dr. Berenice Carrillo
Abstract:
Adeno-associated virus (AAV) vectors stand as one of the most popular technologies for gene therapy, merited to its lack of immunogenicity and pathogenicity in humas, low risk of insertional mutagenesis, long-term transgene expression, and broad range of infectivity. Although rAAV was initially used for the treatment of ultrarare conditions, it is now being used to treat a variety of diseases, thus increasing the demand for large-scale production of rAAV. This presents a challenge as these broader rAAV therapies require higher yields. Here we present the approaches that PackGene has undertaken to increase rAAV productivity and product quality attributes. With the use of PackGene’s proprietary π-Alpha 293 AAV High-yield Platform, and in combination with in-process upstream and downstream QbD optimization of media and feed, we observed an increase in rAAV production by 3 to 8 times in various AAV serotypes. Additionally, a reduction in empty capsid, residual plasmid and host cell DNA was also achieved with improved biological function.
