Continuously Improving Quality And Efficiency Of AAV Manufacturing

The landscape of AAV-based gene therapies is experiencing rapid advancement, encompassing critical areas such as manufacturing, analytics, and regulations, which are core competencies of IDT Biologika, a full-service CDMO specializing in virus-based vaccines and therapies. Explore insights into a robust, cross-serotype, high-yield AAV manufacturing platform designed to achieve short timelines and cost-effective scalability for producing clinical trial and commercial materials in bioreactors with capacities up to 2000 liters. Here, ongoing and future process and analytical development areas are outlined. Learn about the scalable, robust, and high-titer USP platform that was created from the optimization of key parameters and materials in the AAV upstream process, the robust and versatile DSP platform for AAV purification that was developed from thorough in-house studies utilizing a multifactorial decision matrix, and the well-established AAV-specific analytical methods that are being continuously expanded and refined.