Evaluation of AAV vector production from the iCELLis fixed bed bioreactor vessel

AAV gene therapy vectors have demonstrated efficacy in numerous clinical trials, and gene therapy products are now a reality. In support of the commercialization of AAV gene therapy biologics, scalable, high capacity AAV production methods are necessary, and here we describe the use of the iCELLis^® Fixed Bed Bioreactor Vessel (Pall Corporation), a versatile AAV production system that can be used for the production of both research grade and GMP AAV vectors. The iCELLis^® system is ideally suited for use with the triple transfection AAV production method utilizing adherent HEK 293 cells. For routine AAV research vector production in the iCELLis^® Nano high compaction 4 m² vessel is used, with the option to combine up to four vessels in tandem, if vector yields greater than 1 × 10¹⁴ VGs are required. The use of the iCELLis^® system provides a continuum in the vector production platform for pre-clinical AAV vector production to GMP AAV production for clinical trials and commercialization.

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