Summary

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?

2021_Polyplus-Catalent webinar_illustration

Participants: Claire Wartel-Weill, Director of Quality and Compliance, Polyplus-transfection. 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.

In this webinar, 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.

The experts compare the transfection efficiency using FectoVIR®-AAV to the gold standard PEIpro® (Polyplus) for viral vector production. The speakers 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 are assessed. In some cases, results point to significant improvements in yield and quality for certain serotypes and vector combinations.

Developing innovative tools such as FectoVIR®-AAV is critical to enable viral vector manufacturers like Catalent to increase AAV productivity, meet regulatory compliance and offer gene therapy developers optimized processes for clinical and commercial production of their viral vector-based therapies.

 

October 21, 2021. Published on: BioInsights – Optimization of AAV production for high-yielding and scalable GMP processes

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