Scalable AAV manufacturing: addressing challenges across the workflow
Cell & Gene Therapy Insights 2020; 6(11), 1679–1693
As the gene therapy field grows and evolves, adeno-associated virus (AAV) has emerged as one of the most significant vectors for its ongoing development. The number of approved therapies and the clinical pipeline continue to grow, making scalable and efficient solutions for AAV production ever more vital. A successful viral vector manufacturing process must be able to deliver a consistent, pure, and high-titer product that exhibits good safety and efficacy. In this article, both upstream and downstream solutions across the AAV production workflow are discussed. Scalable, high-titer AAV production is demonstrated in an insect-cell based Expression System. In addition, the benefits of implementing affinity chromatography in the downstream purification of AAV are also discussed, along with regulatory requirements for safety and purity testing during the AAV production process.