COLUMBUS, Ohio, Feb. 28, 2024 /PRNewswire/ — Andelyn Biosciences, Inc., a pioneering and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has been selected to manufacture adeno-associated vectors (AAV) therapies in its suspension platform for several programs under the Foundation for the National Institutes of Health (FNIH) Accelerating Medicines Partnership® (AMP®) Bespoke Gene Therapy Consortium (BGTC).
BGTC has chosen to focus on eight rare disease programs, with Andelyn selected to optimize and scale the AAV therapy processes for the treatments of CNGB1 Retinitis Pigmentosa 45 and NPHP5 retinal degeneration. Managed by the Foundation for the National Institutes of Health, AMP BGTC is a public-private partnership between the National Institutes of Health (NIH), the U.S. Food and Drug Administration (FDA), biopharmaceutical and life science companies, and nonprofit and other organizations with a mission to speed the development and delivery of AAV gene therapies that could treat the millions of people affected by rare diseases.
Matt Niloff, Chief Commercial Officer of Andelyn, commented, “As a long-standing pioneer in AAV gene therapies with a focus on patients, we have great synergies with the BGTC. Andelyn is privileged to work with the FNIH/BGTC on its first AMP which was established specifically to help overcome the major obstacles related to developing gene therapies for rare diseases.”
“We are pleased to have Andelyn Biosciences as a manufacturing partner for two programs in the BGTC’s clinical portfolio,” said Courtney Silverthorn, Associate Vice President for Science Partnerships at the FNIH and Director of the AMP program. “This is an important step toward reaching our ultimate goal of getting gene therapies to rare disease patients in need sooner, and with fewer hurdles along the way.”
With exceptional quality and scalable end-to-end development and manufacturing capabilities across its three Columbus, Ohio facilities, Andelyn is enabling the progression of life-altering gene therapies for rare and prevalent diseases.
About Andelyn Biosciences, Inc.Andelyn Biosciences is a full-service cell and gene therapy CDMO focused on the development, characterization and production of 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 450 clinical batches and 75 global clinical trials. Operating out of three Columbus, Ohio facilities, Andelyn supports its clients in developing curative cell and gene therapies from concept through plasmid development and manufacturing, process development, and cGMP clinical and commercial manufacturing. Andelyn’s versatile capabilities include cGMP manufacturing capacity for both adherent and suspension processes up to a 2,000-liter capacity. An advanced digital model, quality system, full regulatory support and supply chain vertical integration help Andelyn accelerate the development and manufacturing of its clients’ innovative cell and gene therapies. For more information, visit andelynbio.com.
About FNIH
The Foundation for the National Institutes of Health (FNIH) builds public-private partnerships that connect leading biomedical scientists at the National Institutes of Health (NIH), life sciences companies, foundations, academia, and regulatory agencies, including the Food and Drug Administration and European Medicines Agency. Through team science, we solve complex health challenges and accelerate breakthroughs for patients, regardless of who they are or what health challenges they face. The FNIH accelerates new therapies, diagnostics, and potential cures; advances global health and equity in care; and celebrates and helps train the next generations of scientists. Established by Congress in 1990 to support the mission of the NIH, the FNIH is a not-for-profit 501(c)(3) charitable organization. For more information about the FNIH, please visit fnih.org.
SOURCE Andelyn Biosciences
