Evaluation of AAV vector production from the iCELLis fixed bed bioreactor vesselPublished: December 18, 2019
Shelley Nass, Bindu Nambiar, Maryellen Mattingly, Denise Woodcock & Catherine O’Riordan
VECTOR CHANNEL: ADHERENT CULTURE METHODS
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.DOI: 10.18609/cgti.2019.154
Submitted for review: September 3, 2019
Citation: Cell & Gene Therapy Insights 2019; 5(11), 1461-1471.