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