Andelyn Biosciences Capacity Update July 2024: Cell & Gene Therapy

This presentation from the July 2024 OPCU event addresses our DOE-based strategy for development of a scalable suspension platform for production and purification of Adeno-Associated Virus (AAV) vectors for gene therapy. To address the myriad of challenges that accompany AAV manufacturing, Andelyn uses a combination of reductionist and holistic approaches to perform end-to-end optimization for its platform. Consistency in productivity and quality are used as benchmarks for evaluation of progress at each stage of development. A direct outcome of the optimization studies is the demonstration of consistency in productivity, purification, and quality across multiple scales. The end-result is a platform with process steps that are modular with options that can be tailored to the specific needs for different AAV transgenes, serotypes and is adaptable to different cell lines.