COLUMBUS, Ohio – Nationwide Children’s Hospital today announces the creation of Andelyn Biosciences, an affiliate company that will manufacture gene therapy products for the biotechnology and pharmaceutical industry scheduled to begin operations in 2023. It will be central Ohio’s first commercial-scale Good Manufacturing Practices (cGMP) clinical manufacturing facility devoted to gene therapies.
Andelyn Biosciences represents an important evolution of Nationwide Children’s Hospital’s current success in clinical manufacturing and gene therapy. The Abigail Wexner Research Institute at Nationwide Children’s 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. The current facility operates according to Food and Drug Administration cGMP guidelines for early stage clinical trials to ensure the safety of manufactured biologic products. Andelyn Biosciences will be established as a for-profit subsidiary company and will continue current GMP operations; beginning this summer, this facility will manufacture products compliant with phase III clinical trial regulations while the new commercial manufacturing site is built and validated.
“We are on the cutting edge of pediatric gene therapy, and clients from around the world currently access AWRI’s knowledge, resources, experience and technology,” said Dennis Durbin, MD, MSCE, chief scientific officer of AWRI. “The goal of Andelyn Biosciences is to support the advancement of novel gene therapies for rare genetic diseases by building commercial manufacturing capacity which is needed as more of these treatments are developed over the coming years. As a for-profit company, revenues generated by Andelyn Biosciences will allow us to reinvest back into the non-profit research mission at AWRI, supporting its commitment to advance best outcomes for children around the world.”
To make Andelyn Biosciences possible, Nationwide Children’s is working with key partners including JobsOhio, the City of Columbus, One Columbus and Rev1 Ventures to create jobs and expand central Ohio’s influence in the biotechnology sector. The Ohio State University’s West Campus innovation district is being explored as a location for Andelyn Biosciences, although an exact location has yet to be finalized.
“Central Ohio is emerging as a life sciences hub and Andelyn Biosciences will create jobs and expand our region’s influence in the biotechnology sector, while accelerating breakthrough therapies,” said Severina Kraner, JobsOhio healthcare director.
“Andelyn Biosciences is another powerful example of the ways Nationwide Children’s Hospital is advancing healthcare and innovation in the Columbus region. The impact they have had, and will continue to have, has proved invaluable to our economy, communities and residents,” said Kenny McDonald, president and CEO of One Columbus.
The name Andelyn Biosciences speaks to the company’s prime mission, representing a hybrid of two pioneering gene therapy recipients who participated in pivotal Phase I clinical trials at AWRI. Andrew Kilbarger was 8 years old when he received the first U.S. human investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn Villarreal was only 8 weeks old when she received investigational gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.
For more information, visit, andelynbio.com. As the planning for Andelyn Biosciences Phase III/commercial operations is still underway, Nationwide Children’s will share more detailed information when available.