About

Our Vision: Pioneering Solutions that turn Hope into Reality Our Mission: Accelerating the development and manufacturing of innovative therapies to bring more treatments to more patients Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions that turn hope into reality as a cell and gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. Having 20+ years of experience with viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting/characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 400+ cGMP clinical batches, Andelyn provides research and tox grade plasmids with an additional offering of GMP plasmid manufacturing, full quality system/regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility will expand capacity across 8+ production suites for customization of new programs and tech transferred programs, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Gene and cell therapy, AAV viral vector manufacturing, Plasmid Manufacturing, Lentiviral vector Manufacturing, Commercial Manufacturing, CDMO, analytical method development, GMP, fill finish, QC/QA release testing, Process Characterization, Regulatory Affairs, Licensing Andelyn Biosciences is a pioneering cell and gene therapy organization born out of Nationwide Children's Hospital, where the first FDA-approved systemic gene therapy was discovered. See all our Press Releases at: https://www.andelynbio.com/media-center About Andelyn Biosciences Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions for Turning Hope into Reality (TM) as a gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. With 20+ years of experience in viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting and characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 450+ cGMP sublots, Andelyn provides research, tox, and GMP grade plasmids Andelyn also has full quality and regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility offers capacity across 16 production suites for customization of new programs as well as tech transfer programs, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Andelyn Biosciences is a pioneering gene therapy CDMO born out of Nationwide Children's Hospital, where the first FDA-approved systemic gene therapy was discovered. About Andelyn Biosciences Andelyn Biosciences (https://www.andelynbio.com/) is pioneering solutions for Turning Hope into Reality (TM) as a gene therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L. With 20+ years of experience in viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting and characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 450+ cGMP sublots, Andelyn provides research, tox, and GMP grade plasmids Andelyn also has full quality and regulatory support and supply chain vertical integration. Its state-of-the-art 185,000 sq ft commercial manufacturing facility offers capacity across 16 production suites for customization of new programs as well as tech transfer programs, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients. Andelyn Biosciences is a pioneering gene therapy CDMO born out of Nationwide Children's Hospital, where the first FDA-approved systemic gene therapy was discovered. 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 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 AAV CuratorTM Platform, or tech transferring in an established client program. Capabilities include cGMP manufacturing for suspension processes up to a 2,000-liter and adherent processes. A rigorous quality system, regulatory support, and supply chain vertical integration further support clients in bringing their critical therapies to market. For more information, visit andelynbio.com. For Andelyn media inquiries, please contact: media@andelynbiosciences.com