White Paper

Bench To Bedside: A Scalable End-To-End Solution For AAV Production

Gene therapy data GettyImages-1054555460

The need for industrialized, cost-effective virus manufacturing platforms is growing rapidly as their usage in precision medicines continues to rise. Among viral delivery systems, recombinantly produced adeno-associated viruses (AAV) are now the predominant vector for in vivo gene therapies with good safety and gene transfer profiles. These viral vectors transport genetic information to a target cell, thereby delivering functional genes needed to correct a genetic defect, to inhibit the cell from producing a defective version of the gene and restore normal function or to impart new function to the cell to treat (cancer treatment) or prevent disease (vaccine). One of the biggest challenges in bringing these life-changing therapies to patients is the ability to efficiently translate bench-scale processes to commercial GMP manufacturing to produce viral vectors at the scale needed to meet dosage requirements. High demands for viral vectors highlight the need to implement easily scalable manufacturing processes while also increasing overall productivity and managing cost of goods. Manufacturers are tasked with developing technologies to produce vectors at the right quantity, quality, and cost to support pre-clinical to clinical development, and ultimately, commercial stage manufacture.

In this paper we look at a typical AAV production process utilizing a feasibility study conducted to evaluate the performance of a platform process for an AAV5 viral vector production and purification. Enabling technologies from Pall were used for each stage of the process to demonstrate a contiguous manufacturing platform with scalable performance for AAV. This platformable approach was modeled after traditional monoclonal antibody workflows where the same platform can work for multiple mAbs.

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