Oct
20
2021
On demand

Optimization of AAV production for high-yielding and scalable GMP processes

The cell and gene therapy market continues to grow rapidly due to increases in the number of approvals for commercial use, molecules reaching late-stage clinical studies, and early-stage targets in development. With this growth, there is a need for critical raw-materials suppliers to develop strategies and products that enable this expansion. Adeno-associated viral vectors (AAV) are the primary vector used for the production of viral vector-based gene therapies with transient transfection as a critical step in the process. Developing a standardized, scalable platform approach is key to address the growing market and accelerated timelines. Catalent Cell & Gene Therapy collaborated with Polyplus to evaluate their novel high-performing transfection reagent FectoVIR®-AAV for scalable production of AAV in suspension HEK-293 cells. 

In this webinar, the experts will compare the transfection efficiency using FectoVIR®-AAV to the gold standard PEIpro® (Polyplus) for viral vector production. The speakers will further present on the optimization study of the transfection protocol and AAV production as well as discuss approaches to build processes with improved vector yield and quality. Product characteristics such as yield, % full capsid, residuals, along with process robustness and scalability up to 200L were assessed. In some cases, results pointed to significant improvements in yield and quality for certain serotypes and vector combinations. Evaluating innovative solutions such as FectoVIR®-AAV that increase productivity while meeting regulatory compliance enables Catalent to offer clients optimized processes for clinical and commercial production of their viral vector-based therapies.

  • How to improve AAV viral vector yields by focusing on transfection step.
  • How to develop a standardized, scalable GMP AAV manufacturing process
  • How to build processes with improved vector yield and quality.
  • How to reach process robustness and scalability

Claire Wartel

Director of Quality and Compliance, Polyplus-transfection

Claire owns a Ph.D. in Molecular Pharmacology and Pharmacochemistry from the University of Strasbourg (France, 1999). After several post-docs in different prestigious universities, Claire joined Polyplus-transfection in 2004 as Cell Biology project leader and participated in the development of our flagship product jetPRIME®. Claire has taken Quality responsibility since 2007, and nowadays manages the department of Quality and Regulatory Affairs.

Mathieu Porte

BioProduction R&D Manager, Polyplus-transfection

After obtaining his Biotechnology Engineering Degree from the renowned European School ESBS (Strasbourg, France), he worked as Research Assistant at New England Biolabs and UCSF. He joined Polyplus-transfection® in 2009. During 10 years in the Bioproduction R&D group, he carried out the development of several innovative transfection solutions dedicated to biomanufacturing.

Bhargavi Kondragunta

Director of Internal R&D & Product Development, Catalent

Bhargavi Kondragunta is currently the Director of Internal R&D & Product Development at Catalent. Prior to Catalent she worked in Biopharma for over 20 years in Process development, CMC, and manufacturing sciences. She has a PhD in Chemical & Biochemical Engineering from UMBC, Maryland, and an M.S. in ChemE from Drexel University, Philadelphia. Most recently she led the process development efforts for Gene therapy vectors at REGENXBIO, and prior to that worked at several Biopharma including BMS, E-Merck, and GSK.

George Buchman

Vice President, Pre-Clinical and Process Development, Catalent Cell & Gene Therapy

Dr. Buchman joined Catalent through its acquisition of Paragon Gene Therapy in 2019. He has more than 30 years of experience in the biotech industry and has held roles at companies including Life Technologies (now Thermo Fisher), Celera Genomics and GeneLogic. Dr. Buchman obtained a bachelor’s degree in biochemistry from Albright College, Reading, Pennsylvania, and a doctorate in biochemistry from University of Maryland.

SPEAKERS

Claire Wartel-Weill
Director, Quality & Compliance
Mathieu Porte
BioProduction R&D Manager, Polyplus-transfection
Bhargavi Kondragunta
Director of Internal R&D & Product Development, Catalent
George Buchman, PhD
Vice President, Pre-Clinical and Process Development, Catalent Cell & Gene Therapy

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