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 members of our current team discovered and developed the first FDA-approved systemic gene therapy. As a specialized gene therapy CDMO and viral vector CDMO, we concentrate on AAV manufacturing services and related development support.
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®.
Partner with us for the advancement of life-changing gene therapies
Substantiated by decades of pioneering research, closeness to patients, and the production of over 500 GMP batches of viral vector therapies for rare diseases, along with the origin of a currently approved gene therapy, Andelyn Biosciences is a proven full-service gene therapy CDMO and viral vector CDMO with deep scientific and manufacturing expertise and a track record of success, including end-to-end AAV manufacturing services.
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 capabilities, delivering integrated AAV manufacturing services aligned to program needs.
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, complementing our role as a viral vector CDMO.
Process Development
We manufacture GMP as well as research and toxicology grade plasmids which support pilot, proof-of-concept, dose confirmation and IND-enabling toxicology studies, complementing our role as a viral vector CDMO.
Laboratory Services
The thoroughness of our analytical development and quality control underpins our commitment to advancing gene therapy, ensuring quality, safety, and efficacy through specialized assays and release testing.
Technology Transfer
Andelyn has extensive experience in both analytical and process tech transfers, including transferring external assays and installing entire processes across facilities, strengthening our AAV manufacturing services.
Curator® Platform
Andelyn’s 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
Your medical indication, patient population, and gene of interest are unique. Our approach to platforming gene therapy processes from preclinical to GMP manufacturing evaluates variables against your specific requirements. We configure each program with Optimization-By-Design™ to deliver a refined manufacturing process tailored to exacting specifications and supported by AAV manufacturing services.
Configurable
Modular platform with assessment and strategy adapted to each program drives faster optimization.
Optimization Toolkit
QbD guidelines and DoEs with step-wise focus on process understanding maximizes program efficiency.
Data Driven
Historical data leveraged to achieve high yield and high-quality products with predictable performance.
Our Facilities
Our two facilities in Columbus, OH, are designed to support your project’s evolution from concept to reality, with capacity for today and room to expand. Each purpose-built center advances gene therapies while fostering strong partnerships.
At Our Core
Our passion for patients and rare diseases stems from our history at Nationwide Children’s Hospital. Many of us have seen patients thrive after receiving life-altering treatments motivates us to Turn Hope Into Reality®.
Empowering 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.