Newswise — Andelyn Biosciences, Inc, a contract development and manufacturing organization (CDMO) and an affiliate company of Nationwide Children’s Hospital, has received a significant, minority investment from Pall Corporation. Additionally, as part of the investment, Pall Corporation and Cytiva, have entered into strategic partnership agreements with Andelyn.
“The strategic partnership with Pall Corporation and Cytiva marks a significant milestone in Andelyn’s ability to accelerate its vision to pioneer solutions that turn hope into reality,” said Mayo Pujols, CEO of Andelyn Biosciences. “It shows a growing confidence in Andelyn’s future as we expand our services into Phase 3 and commercial manufacturing, allowing us to serve a variety of clients and accelerate the development and manufacturing of innovative cell and gene therapies.”
Andelyn is expanding its process development, analytical development and quality control capabilities. The company is also increasing its capacity to produce AAV and lentiviral vectors. In addition, the company is now offering clinical-grade plasmid manufacturing services, which helps advance drug delivery timelines for clients.
Andelyn Biosciences’ unique business model allows for reinvestment into the pioneering research and technologies developed at the Abigail Wexner Research Institute (AWRI) at Nationwide Children’s to discover new cures and treatments for pediatric diseases. This forward-thinking business model allows Andelyn to support the future of cell- and gene-based therapies.
Joe Repp, President, Pall Life Sciences, said, “Gene therapy advancements have the potential to cure debilitating diseases and improve the lives of millions of people around the world, but challenges with limited capacity and expertise in the critical area of viral vectors continue to slow development and must be addressed. The combined expertise of Pall, Cytiva and Andelyn will help address the industry’s current bottlenecks and advance innovation.”
Emmanuel Ligner, President and CEO, Cytiva, said, “Advancing and accelerating the development of novel therapeutics requires strategic collaborations. Our strategic partnership with Andelyn Biosciences will provide them with the technologies and solutions needed to manufacture life-changing therapeutics.”
“Andelyn Biosciences represents an important evolution of Nationwide Children’s current success in clinical manufacturing and gene therapy,” said Tim Robinson, CEO of Nationwide Children’s. “The Abigail Wexner Research Institute has become 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. The commitment from Pall Corporation and Cytiva is a testament to Andelyn’s important work.”
In November 2020, Andelyn broke ground on a new 185,000 square foot facility that will include eight customizable product manufacturing suites, six plasmid manufacturing suites and two suites for the fill finish of product and plasmids. It is located at 1180 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 cell and gene therapies.
Andelyn’s new facility will create an additional 250 jobs and the company will invest $200 million in the Columbus region. Andelyn has received support from local and state economic development organizations such as JobsOhio, One Columbus and the City of Columbus for this expansion.
William Blair & Company served as exclusive financial advisor, Morgan, Lewis & Bockius LLP served as legal counsel to Andelyn Biosciences and Nationwide Children’s, and Vorys, Sater, Seymour and Pease LLP served as special legal counsel to Nationwide Children’s.
About Nationwide Children’s Hospital
Named to the Top 10 Honor Roll on U.S. News & World Report’s 2020-21 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit freestanding pediatric health care systems providing wellness, preventive, diagnostic, treatment and rehabilitative care for infants, children and adolescents, as well as adult patients with congenital disease. Nationwide Children’s has a staff of more than 13,000 providing state-of-the-art pediatric care during more than 1.6 million patient visits annually. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Abigail Wexner Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded freestanding pediatric research facilities. More information is available at NationwideChildrens.org.
About Andelyn Biosciences
Andelyn Biosciences is a pioneering gene therapy company born out of Nationwide Children's Hospital, where the first FDA-approved systemic gene therapy was discovered. Andelyn is named in honor of two gene therapy pioneers who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital—8-year-old Andrew and 8-week-old Evelyn.
Bringing together more than 15 years of experience in AAV vector manufacturing, Andelyn is a full-spectrum Contract Development Manufacturing Organization (CDMO) that helps pioneer solutions that turn hope into reality. Our mission is to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We accomplish this by bringing scalability, capacity, efficiency and expert resources to manufacturing matrices, all to advance the development of viral vector-based therapeutics. Our capabilities include viral vector process and analytical development, small to large scale GMP manufacturing, fill/finish and QC/QA release testing through Phase III with plans to launch commercial services in 2022. Andelyn also offers plasmid manufacturing services, formulation development services and regulatory support.
As a global provider of cell and gene therapy solutions, from its roots at Nationwide Children’s Hospital, Andelyn has been a trusted partner in over 60 US, EU and ROW clinical trials. Discover more about our capabilities at AndelynBio.com.
Cytiva is a global life sciences leader with more than 7,000 associates across 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients.
About Pall Corporation
Pall Corporation is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across the broad spectrum of life sciences and industry. Pall works with customers to advance health, safety and environmentally responsible technologies. The company’s engineered products enable process and product innovation and minimize emissions and waste. Pall Corporation serves customers worldwide. For more information visit www.pall.com or follow us on social media: LinkedIn, Twitter, Facebook.