Keys to AAV manufacturing Success: Fast, robust and high-yield process development with DOE, Automated Bioreactors and selected critical raw materials

rAAVs are the preferred viral vector for gene therapy due to serotype-specific tropism, durable transgene expression and a growing number of approved and commercialized therapies. Manufacturers and developers are more than ever striving to simplify their manufacturing process whilst improving robustness and cost-effectiveness. Here we present a case study demonstrating the importance of selecting key critical raw materials such as transfection reagent FectoVIR®-AAV, and plasmid pPLUS®AAV-Helper for process performance, combined with a high-throughput production platform that integrates DOE with automated, single-use bioreactors to establish a scalable, high-yield rAAV upstream manufacturing platform suitable for preclinical and clinical supply.