Overcoming upstream and downstream process barriers for large scale AAV production
Jun
15
2023
On demand

Overcoming upstream and downstream process barriers for large scale AAV production

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Sponsor
Overcoming upstream and downstream process barriers for large scale AAV production

Given the broad treatment potential and demonstrated efficacy of recently approved viral vector-based gene therapies, there is an established need for reproducible and consistent manufacturing solutions that yield high titer, high quality viral particles for clinical applications. It is critical to implement a robust manufacturing process that addresses the upstream and downstream production challenges of obtaining sufficient titers and purity for in vivo applications, while also meeting safety and regulatory requirements for clinical use.

We bring together industry and commercial perspectives to discuss key barriers to address clinical needs and market supply of gene therapies. Hear experts from Thermo Fisher Scientific and Encoded Therapeutics explore solutions to overcome these issues and provide a practical example of implementation. Gain valuable insights and strategies to optimize your AAV manufacturing processes and accelerate the development of safe and effective gene therapies.

  • Find out about an end-to-end solution for development and commercial production of AAV
  • Learn how new products and technologies can help address production efficiency, regulatory concerns, and scale-up of AAV production protocols
  • Understand how critical manufacturing challenges are currently being addressed by gene therapy developers
Betty Woo
Betty Woo
Vice President, Cell, Gene and Advanced Therapies, Thermo Fisher Scientific

Betty currently serves as Vice President of Cell, Gene, and Advanced Therapies, spanning biosciences, bioproduction, and laboratory products businesses across Thermo Fisher Scientific, leveraging “total company” to address the needs of developers and manufacturers of cell and gene therapies. The business focuses on fit-for-purpose product solutions that in partnership with our customers, is increasing the accessibility of these life-changing cell and gene therapies to patients.

Prior to this role, she formed and led a corporate team focused on scientific collaborations with Thermo Fisher strategic customers, as Vice President, Enterprise Science & Innovation (2018-2020), and served as VP of Corporate Accounts with responsibility for cultivating executive relationships with global biopharma (2009-2017). Prior to her corporate roles, Betty served in leadership roles in Fisher Scientific, including Industry Vice President, Biotechnology (2004-2008); Vice President of Life Sciences Specialists (2006-2008); and Senior Director of Marketing, Biotechnology (2003-2004). Prior to Thermo Fisher, she served in various technical and business leadership positions for Cellomics, a biotechnology start-up company (1998-2003), and was on the faculty of the University of Pittsburgh Medical School, in the Department of Pharmacology (1991-1998). Dr. Woo currently serves on several advisory boards including the Standards Coordinating Body, International Society for Cell & Gene Therapy, Carnegie Museum of Natural History, and the Pittsburgh Life Sciences Greenhouse.

Adam Miller
Adam Miller
Director, Upstream Process Development – Encoded Therapeutics

Adam Miller serves as Director of Upstream Process Development at Encoded Therapeutics, where he has successfully established a best-in-class rAAV expression platform. He has a proven track record of establishing Upstream Process Development capabilities at multiple biotechnology companies and has played a pivotal role in advancing numerous programs from early R&D to clinical manufacturing.

As a subject matter expert, Adam's core competencies include the development, scaleup, and transfer of challenging cell culture processes. His past work has made possible the advancement of programs otherwise limited by product quality or sensitive cell lines. Upon entering the Gene Therapy field in 2019, he has applied his expertise to building an HEK293-based expression platform which surpasses conventional limitations. The ability to produce larger quantities of vector at lower cost has been transformative for Encoded. It has enabled a ‘Right-Sized’ manufacturing approach, accelerated research timelines, and broadened potential market supply.

Jonathan Zmuda
Jonathan Zmuda
Director, R&D Cell Biology, Thermo Fisher Scientific

Jonathan Zmuda, Ph.D. is a Director of Cell Biology R&D within the Biosciences Division of Thermo Fisher Scientific located in Frederick, MD (USA). Within Cell Biology, Jon leads various teams that focus on developing new technologies for protein expression, viral vector production, transfection and classical cell culture. Dr. Zmuda received his Ph.D. in Cell Biology from the University of Maryland, College Park and his undergraduate degree from Dickinson College in Carlisle, PA.