Webinar: Current Challenges and New Approaches to Developing rAAV Manufacturing Processes for Large-scale GMP Production

Abstract

Adeno-associated virus (AAV) production faces significant challenges, including low yields, scalability issues, and inconsistent quality. Scaling up AAV production to meet clinical and commercial demands requires innovative solutions. PackGene’s proprietary π-Alpha 293 AAV High-yield Platform addresses these challenges by utilizing a uniquely designed RC plasmid within a triple-plasmid transfection system. This approach boosts AAV production by 3 to 8 times across various serotypes. Additionally, the platform integrates in-process upstream and downstream Quality by Design (QbD) optimizations, enhancing total AAV yield up to 10-fold. A single batch of production can deliver high-yield vector genomes, sufficient for most clinical and commercial AAV applications.

Time

7/02/2024 2:00 pm EST/ 11:00am PST

Speaker:

Name: Dr. Berenice Carrillo

Company: PackGene Biotech USA

Title: Associate Director of Process and Analytical Development

Dr. Berenice Carrillo is the Associate Director of Downstream Process and Analytical Development at PackGene Biotech where she oversees the design and development of robust, efficient, and scalable downstream processes using the company’s proprietary AAV platform technology. Prior to joining PackGene, Dr. Carrillo was the Director of Downstream Process Development for iBIO CDMO where she managed the development of internal and external client projects. She holds a Bachelor of Science degree in Biochemistry from New Mexico State University and earned her Ph.D. in Molecular Virology and Microbiology from Baylor College of Medicine. Overall, her career as a protein biochemist spans 20 years, where she focused on protein engineering of viral and plant proteins, protein purification, and protein crystallography.

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Name: Dr. Ran Li

Company: PackGene Biotech USA

Title: Associate Director of Process and Analytical

Dr. Ran Li is a distinguished professional in biotechnology, with a focus on cell and gene therapy and monoclonal antibodies. Since 2022, Ran has been the Associate Director at PackGene Biotech, leading the development of AAV viral vectors for gene therapies. Before joining PackGene, Ran held senior roles at CTMC and Bellicum Pharmaceuticals, where he specialized in viral vector production and T cell therapies. He also served as a Senior Scientist at Klus Pharma. Ran earned a Ph.D. in Pharmacology & Cancer Biology from Duke University, completed postdoctoral research at UT Southwestern and Texas A&M, and holds an undergraduate degree from Tsinghua University.

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