The field of gene therapy has made a major comeback over the last decade, resulting in a significant paradigm shift in medicine. Due to improved safety and efficacy, the Adeno-Associated Virus (AAV) has emerged as one of the most important vectors for the development of gene therapies. With a handful of approved therapies available in Europe and US, and an extensively growing pipeline of clinical trials, it is evident that scalable and efficient solutions across the production workflow are needed.
Each production process for viral vectors has its own unique impediments and AAV is no exception. A successful viral manufacturing pipeline must deliver a consistent, pure, and high-titer product that exhibits good safety and efficacy to meet regulatory expectations.
During this webinar, upstream and downstream solutions across the AAV production workflow, are outlined. Scalable, high-titer AAV production is demonstrated in two cell host systems: a helper free 293F-based suspension system and the insect-cell based ExpiSf™ Expression System. In addition, we outline the benefits of implementing affinity chromatography in the downstream purification of AAV, including the viral clearance potential. Furthermore, we will address regulatory requirements for safety and purity testing during the AAV production process and discuss the benefits of implementing automated systems to save time and demonstrate product quality and safety.