Andelyn Biosciences Breaks Ground for New Commercial-Scale Gene Therapy Manufacturing Facility
COLUMBUS, Ohio – Andelyn Biosciences, an affiliate company of Nationwide Children’s Hospital that manufactures gene therapy products for the biotechnology and pharmaceutical industries, has broken ground on its new site located at 1250 Arthur E. Adams Dr. in The Ohio State University’s Innovation District. Opening in 2022, it will be central Ohio’s first commercial-scale Good Manufacturing Practices (cGMP) production facility devoted to gene therapies.
Andelyn Biosciences will create more than 200 new jobs (in addition to a baseline of more than 100 full-time employees) and invest more than $100 million in a new gene therapy contract development and manufacturing organization (CDMO) in Columbus. The 185,000 square foot facility will add a critical element to central Ohio’s cell and gene therapy ecosystem as world-class researchers, biotechnology facilities and a growing investor base have created a hub of gene therapy excellence. The project is being assisted with a $5 million JobsOhio Research and Development Center Grant.
To make Andelyn Biosciences possible, Nationwide Children’s is working with key local partners, including JobsOhio, the City of Columbus, Columbus City Schools, One Columbus, The Columbus Partnership and Rev1 Ventures to create jobs and expand central Ohio’s influence in the biotechnology sector.
“This is an exciting time for Andelyn Biosciences as we are one step closer to offering a wider portfolio of capabilities and services that will ultimately be game changing for our clients,” said Mayo Pujols, chief executive officer of Andelyn Biosciences. “I want to thank all of our local partners for their support. Together, we are working to serve many patients around the world who need life-saving therapies.”
Andelyn Biosciences is a for-profit manufacturer, but its unique business model will lead to reinvestment into pioneering research conducted at the Abigail Wexner Research Institute (AWRI) at Nationwide Children’s. This research ranges from basic discovery science to clinical studies to population health research, all to address challenges affecting children’s health.
Andelyn Biosciences represents an important evolution of Nationwide Children’s current success in clinical manufacturing and gene therapy. AWRI is now widely recognized among the nation’s leaders in developing gene therapies, which are becoming safe and effective treatments for previously fatal or untreatable genetic diseases. For several years, AWRI has operated a small-scale facility on-site focused on the manufacture of early-stage gene therapy products for Phase I and II clinical trials.
Andelyn Biosciences, currently leasing facility space from AWRI, operates according to Food and Drug Administration and other international health authorities cGMP guidelines for early stage clinical trials to ensure the safety of manufactured biologic products. It will begin to manufacture products compliant with Phase III clinical trial regulations while the new commercial site is built and validated. The new facility will expand Andelyn’s capabilities to include commercial-scale production.
The land lease for Andelyn Biosciences has been executed with SciTech. The architect for the project is CE&IC, and the contractor is Gilbane.
About Andelyn Biosciences
Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on developing, characterizing, and producing viral vectors for gene therapy. With more than 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of cGMP material for more than 500 clinical batches and 85 global clinical trials. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high-quality products by developing and manufacturing processes on its configurable, data-driven Curator® Cell and Gene Therapy Platforms, or by tech transfer within an established client program. Capabilities include cGMP manufacturing for suspension and adherent processes. A rigorous, commercial-grade quality system, phase-appropriate manufacturing, and supply chain vertical integration further help clients bring critical therapies to market.
For more information, please visit andelynbio.com and follow Andelyn Bioscienceson LinkedIn.
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