Andelyn Biosciences opens GMP manufacturing facility

By Rachel Arthur

- Last updated on GMT


Related tags Gene therapy Viral vectors Cell line Plasmids

US gene therapy CDMO, Andelyn Biosciences, has opened a new GMP clinical and commercial manufacturing facility to support cell and gene therapy (CGT) development and manufacturing.

Located in Columbus, Ohio, the Andelyn Corporate Center (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. 

This investment is the latest step in Andelyn Biosciences’ growth plan after its launch and opening of the GMP Andelyn Plasmid Core (APC) in August and Andelyn Development Center (ADC) in June.

End-to-end services

The new site will help the Andelyn’s Biosciences support over 100 new clients, according to the company. Furthermore, the full-service CDMO says it has been successful in reducing the time to manufacturing by more than 50% per production: manufacturing in less than four months to improve turnaround time for clients’ programs.

“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," ​says the company.

"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 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.”

The new 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.

Andelyn - which is owned and supported by Nationwide Children’s Hospital (NCH) and Pall-Cytiva, part of Danaher Corporation - has also recently added to its service offerings. Andelyn’s own cell line and plasmids can now be licensed to clients, with some available immediately off the shelf. Meanwhile, regulatory support for IND filing is possible through Andelyn’s partnership with Nationwide Children’s Hospital (NCH).

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