Achieving Agile, Expert Scale-Up With Andelyn's New Manufacturing Capacity

There are many factors that can influence speed-to-market for advanced therapies. While many CDMOs have attempted to position themselves as “flexible” or “agile” within the greater biologics landscape, finding a manufacturing partner that possesses the capabilities and capacity to offer a truly end-to-end development and scale-up can mean the difference between successful development and the end of the road. Andelyn’s network of facilities exploits existing expertise in AAV manufacturing, plasmids, and viral vectors, and allows for innovation to support new and novel manufacturing processes that increase yields, improve recoveries, and streamline overall development. By integrating our core competencies, Andelyn is able to collaborate across a greater range of therapeutic modalities and address emerging challenges in a space that is constantly evolving and increasingly complex.

Andelyn’s capabilities span viral vector process and analytical development, small- to large-scale adherent- and suspension-based GMP drug substance manufacturing up to 2,000L, and finished drug product manufacturing services. With over two decades of experience in viral vector manufacturing, we offer our clients direct access to globally recognized thought leaders in troubleshooting and yield optimization expertise, resulting in GMP material production for 75+ worldwide clinical trials. With the experience gained from over 450 cGMP clinical sublots and more than 2,000 research-grade productions, Andelyn provides its clients with research and toxicology-grade plasmids with an additional offering of GMP plasmid manufacturing, advanced quality systems, full regulatory support, and supply chain vertical integration.