Andelyn opens CGT manufacturing plant in Ohio

CDMO Andelyn Biosciences has opened a clinical and commercial manufacturing facility in Columbus, Ohio to support cell and gene therapy (CGT) development.

Contract development manufacturing organization (CDMO) Andelyn has opened a manufacturing facility in Ohio, which it has named the Andelyn Corporate Center (ACC). The firm says that the 200,000 square-foot gene therapy production plant has the capability to support any scale of gene therapy viral vector manufacturing.

“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,” said Eric Blair, chief commercial officer at Andelyn.

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“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.”

According to the firm, the site uses a variety of modalities including Pall’s single-use bioreactor system iCELLis and has suspension platform capacity of up to 8 x 2,000 L. Additionally, Andelyn claims the site has equipment for analytical development, GMP manufacturing, and quality control.

The facility also includes an integrated design with individual air handlers in every suite in order to prevent contamination and minimize risk to its programs.

100 new clients

The company says that it will support more than 100 new clients with several programs starting from concept all the way through to commercialization with services ranging across analytical development, process development, and preclinical production.

Furthermore, Andelyn states that it also offers starting materials like research, toxicology, and GMP plasmids, with a specific focus on customer success in the clinical and commercial manufacturing space.

“Accelerating treatments to patients has always been at the heart of our mission,” said chief operating officer at Andelyn, 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.”