Pioneering Solutions That Turn Hope Into Reality

As the number of AAV-mediated gene therapies in clinical trials continues to rise, increased demand for doses is requiring developers to efficiently scale-up their manufacturing processes. Developing a robust, scalable platform that can meet the needs of all clinical phases with consistent high yields, recoveries, purity, and quality is crucial to ensure a seamless transfer from pre-clinical to commercial.

Andelyn Biosciences is a concept to commercialization CDMO that is dedicated to the mission of pioneering solutions to bring more treatments to more patients. A spinout of Nationwide Children’s Hospital, Andelyn has a 20+ year history in cell and gene therapy development and GMP manufacturing, having produced over 450 sublots and supported over 75 INDs. Andelyn has leveraged this knowledge to develop a robust suspension AAV manufacturing platform that has a linearity of scale from flask to 2000L as well as the flexibility needed to accommodate multiple serotype and transgene combinations.

Explore how to achieve linearity in scale-up and consistency in production, and learn about Andelyn's approach in making the development cycle a part of the platform to leverage accelerators and multipliers throughout the product lifecycle.