The Use Of A Proven AAV Platform To Drive Down Program Costs And Maximize Speed

By Andy Moreo, Head of Process Development and Preclinical Manufacturing, Andelyn Biosciences

Cell and gene therapies are increasingly popular vehicles for treating rare and devastating diseases. As their foothold grows, sponsors are beginning to explore how these technologies can treat more common indications as well. Though the potential is extremely promising for patients across the biopharma space, regulatory bodies are still working to craft guidance that helps sponsors navigate development and current good manufacturing practice (cGMP) protocols. When a sponsor is beginning their adeno-associated virus (AAV) development and manufacturing journey, much of their success will be tied to the expertise of the contract development and manufacturing organization (CDMO) they choose to partner with.

A CDMO with robust AAV manufacturing experience and expertise — from research and development to clinical and commercial scale — is a rare find. While many CDMOs may have the capacity, equipment, and space to manufacture, they may not necessarily have the technical know-how or functional understanding to deliver a high-quality product according to timeline. Download the full article to learn more about the defining characteristics of an experienced and efficient AAV manufacturer.