Andelyn Biosciences announces opening of its state-of-the-art GMP manufacturing facility to meet industry demand

Andelyn Biosciences, Inc., a world-leading gene therapy CDMO, announced the addition of a new GMP clinical and commercial manufacturing facility, the  Andelyn Corporate Center (ACC), to its network of flexible and scalable sites that  support cell and gene therapy (CGT) development and manufacturing. This  investment is the latest execution of Andelyn’s Biosciences’ growth plan after its  launch and opening of the GMP Andelyn Plasmid Core (APC) in August 2022 and  Andelyn Development Center (ADC) in June of 2022.

Located in Columbus, Ohio, the ACC is an advanced 200,000 square foot gene therapy GMP clinical and commercial manufacturing facility. The site has capability to support any scale of gene therapy viral vector production using various modalities including adherent, iCELLis®, and suspension platform  capacity of up to 8 X 2000L.

With a full suite of equipment for analytical development, quality control and GMP manufacturing, Andelyn’s ACC will support partners’ needs for speed with its experienced team and end-to-end services. Serving a broad range of CGT companies on their accelerated journey to market, Andelyn offers plasmids, preclinical and clinical development as well as clinical and commercial manufacturing.

The company will support over 100 new clients with multiple programs from concept to commercialization with services across process development, analytical development, and preclinical production. Andelyn also offers starting  materials such as research, toxicology, and GMP plasmids, with a focus on client success in clinical and commercial manufacturing of viral vectors and other modalities.

This state-of-the-art facility includes an integrated design with individual air  handlers in each suite to prevent contamination, in addition to design,  engineering, and controls to minimize risk to any program. Combined with the  highly experienced team at Andelyn that has manufactured over 400 GMP batches without failure, Andelyn clients will be working in strategic partnership with expert drug manufacturers.

Eric Blair, Chief Commercial Officer, said: “We built the ACC in response to  increasing customer demand for regulatory-compliant, high quality, scalable viral vector production – all at a pace of delivery unseen in the market previously. It demonstrates Andelyn’s commitment to providing end-to-end services for the accelerated delivery of critical gene therapies to patients. Our clients are choosing us as their strategic partner for our flexibility, experience, and patient focus.”

Andelyn is a full-service CDMO and has been successful in reducing the time to manufacturing by more than 50% per production. By manufacturing in less than four months, Andelyn has become an industry leader not only in quality, experience, and scale, but also in turnaround time for clients’ programs.

“Accelerating treatments to patients has always been at the heart of our  mission,” said Chief Operating Officer Wade Macedone. “Andelyn Biosciences was founded in a small lab on the campus of Nationwide Children’s Hospital.  Since then, I have been lucky to witness our extraordinary growth as an independent company. We are now a world-class CDMO, with the ACC at the center of our services, built intentionally to deliver the best possible product to our clients at an unmatched pace because, at the end of the day, our clients deliver hope into the hands of patients.”

In addition to the ACC launch, Andelyn has recently added to its service  offerings. Clients will have access to Andelyn’s own high-quality cell line and plasmids that are licensed with accessible terms to clients, with some available  immediately off the shelf. Regulatory support for IND filing is possible through Andelyn’s partnership with Nationwide Children’s Hospital (NCH), which is nationally recognized for its experience with IND filings. Finally, Andelyn’s GMP manufacturing for clinical through commercial production, as well as the end-to-end aseptic drug product manufacturing, make Andelyn an easy choice as a strategic partner.

The Andelyn Corporate Center (ACC) clinical and commercial manufacturing facility is officially open and ready for scaled GMP manufacturing to serve the industry in a broader capacity.