Abstract
Production methods for adenovirus-associated virus (AAV) vectors have not kept up with the brisk pace of gene therapy development. To manufacture safe and efficacious clinical- grade virus, scalable and cost-effective production processes are needed. Towards this end, we present an efficient process for AAV production and scale-up in suspension cell culture through to purified bulk product. The process was developed by evaluating and optimizing each process step. A novel fiber technology, Fibro, addresses the downstream bottleneck at the capture step by overcoming the diffusional and flow limitations of purification using packed-bed chromatography. Also, a new analytical assay based on surface plasmon resonance was developed for AAV quantitation.
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