Andelyn Biosciences Capacity Update October 2023: Cell & Gene

This presentation from the October 2023 Outsourced Pharma Capacity Update focuses on the development of Andelyn’s Suspension Platform. A major hurdle for manufacture of Adeno-Associated Virus (AAV) vectors is scalability, production yields, quality, and a clean feed-stream to facilitate effective purification strategies. Using a DOE strategy, Andelyn has developed a high yielding, scalable suspension platform for production of high quality AAV. Andelyn has also derived a clonal suspension cell line capable of producing higher AAV yields that can be optimized using a similar strategy and is available for GMP AAV manufacturing. We detail this strategy and present three case studies that highlight how the platform was used for scale-up and optimization for tox and clinical productions.