Turning Hope Into Reality™
Accelerating the development and manufacturing of innovative therapies to bring more treatments to more patients.
Pioneers in Cell and Gene Therapy
Andelyn Biosciences is a gene therapy contract development and manufacturing organization born out of Nationwide Children's Hospital and based in Columbus, OH, where the first FDA-approved systemic gene therapy was discovered and worked on by members of our current team.
What's Behind Our Name?
Our values are founded in our origin story.
The name “Andelyn” is a hybrid of two gene therapy pioneering patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received an experimental gene therapy for spinal muscular atrophy in 2015.
“Andelyn” combines their names, representing all the families who have courageously participated in the research that make today’s gene therapies possible, and inspires our vision of Turning Hope Into Reality™.
Advancing Discoveries.
Manufacturing Cures.
Acknowledging the value of the experience and capabilities developed over the years, Nationwide Children’s Hospital spun off Andelyn as a separate for-profit CDMO in January 2020 to serve gene therapy researchers and developers with dedicated facilities and personnel, tailored to meet the rigorous demands required to bring these critical therapies to the patients who need them.
Our Capabilities
Andelyn provides a full suite of services to accelerate your path from concept to commercialization. Explore how our focused capabilities can drive your program to success.
Viral Vector Manufacturing
Andelyn Biosciences provides clients with comprehensive viral vector AAV adherent and suspension manufacturing solutions and services. We support our clients throughout every step of cGMP manufacturing from preclinical to commercial production.
Plasmid Manufacturing
We manufacture GMP as well as research and toxicology grade plasmids which support pilot, proof-of-concept, dose confirmation and IND-enabling toxicology studies.
Process Development
We use a set of rigorous process development guidelines for process characterization, DoE and QbD principles to establish, implement and improve our clients’ viral vector manufacturing processes.
Analytical Development
The thoroughness of our analytical development underpins our commitment to advancing gene therapy, ultimately ensuring the highest quality, safety, and efficacy of our products for those who depend on them the most.
Technology Transfer
Andelyn has extensive experience in both analytical and process tech transfers, including everything from transferring external assays to and moving and installing entire processes across facilities.
AAV Curator™ Platform
Andelyn's AAV Curator™ Platform is built on configurability and ensures the end process is curated to your program's specific needs. Our modular approach uses configurable materials and methods optimized for your process requirements and reinforced with data and analytics.
AAV Curator™ Platform
Powered by Optimization-By-Design™
Your medical indication, patient population, and gene of interest are unique, so the promise of a one-size-fits-all or plug-and-play platform is not so easily realized. Our approach to platforming gene therapy processes from preclinical to GMP manufacturing takes all of the variables into account and evaluates them against your specific requirements.
Our knowledge, expertise, and experience are the content at Andelyn: we evaluate and configure each program with Optimization-By-Design™ in mind. The end result is a refined and tailored manufacturing process curated to meet your exacting specifications.
Modular platform with assessment and strategy adapted to each program drives faster optimization.
QbD guidelines and DoEs with lean, step-wise focus on process understanding maximizes program efficiency.
Historical data leveraged to achieve high yield and high-quality products with predictable performance.
Our Facilities
Our three facilities in Columbus, OH, are meticulously designed to support your project's evolution from concept to reality. We're not just about meeting today's needs but also about anticipating the demands of the future with ample capacity to support our clients today and the ability to expand our operations as needed.
Explore the unique role each of our purpose-built centers plays in advancing gene therapies, setting new industry standards for excellence and partnership.
At Our Core
Our passion for patients and rare diseases stems from our history at Nationwide Children's Hospital and we've carried that spirit of community involvement with us to Andelyn. Many of us have observed patient dosings and seeing them thrive after receiving the life-altering treatments that we have manufactured motivates us all do to everything we can to Turn Hope Into Reality™.
Andelyn is proud to be in the vanguard of the strong and growing biotechnology ecosystem in our native Ohio and we're dedicated to advocating and volunteering for local charities and initiatives that align with our core values.
News & Press Releases
July 10, 2024
Andelyn Biosciences Selected by UMass Chan Medical School to Manufacture Clinical Grade AAV9-CSA Vector to Treat Cockayne SyndromeAndelyn Biosciences Selected by UMass Chan Medical School to Manufacture Clinical Grade AAV9-CSA Vector to Treat Cockayne SyndromeJune 11, 2024
UMass Chan Receives $2.2 Million to Fund Gene Therapy for Cockayne SyndromeUMass Chan Receives $2.2 Million to Fund Gene Therapy for Cockayne SyndromeMay 23, 2024
Andelyn Biosciences Selected as Viral Vector Manufacturing Partner for the California Institute for Regenerative Medicine (CIRM) Accelerating Medicines Partnership (AMP) Bespoke Gene Therapy Consortium (BGTC)Andelyn Biosciences Selected as Viral Vector Manufacturing Partner for the California Institute for Regenerative Medicine (CIRM) Accelerating Medicines Partnership (AMP) Bespoke Gene Therapy Consortium (BGTC)March 25, 2024
Andelyn Biosciences and Grace Science, LLC Partner to Tech Transfer Phase I/II/III Manufacturing of a Suspension Process Adeno-Associated Virus (AAV) Gene Therapy for NGLY1 DeficiencyAndelyn Biosciences and Grace Science, LLC Partner to Tech Transfer Phase I/II/III Manufacturing of a Suspension Process Adeno-Associated Virus (AAV) Gene Therapy for NGLY1 DeficiencyEmpowering Our Community Through Science and Service
At Andelyn Biosciences, we believe in giving back and forging strong community connections. Our dedication extends beyond manufacturing science and technology, as we actively participate in community service, educational outreach, and partnerships that promote public health and scientific literacy. Discover how we’re making a difference in communities locally and globally.