Helping our Clients Turn Hope into Reality

Andelyn Biosciences is pioneering solutions that turn hope into reality as a biopharmaceutical CDMO. With 20+ years of experience manufacturing viral vectors, Andelyn’s scientific expertise for development and characterization has led to GMP material being produced for over 75+ worldwide clinical trials and 400+ cGMP clinical batches. Advanced quality systems, full regulatory support, and supply chain vertical integration help accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients.
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Clinical and Commercial Manufacturing
We provide our clients with a broad range of adherent and suspension-based viral vector and vaccine manufacturing services. Our cGMP facilities offer scalability up to 2000L and the reliability of platform processes and quality systems.
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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 and vaccine manufacturing processes.
Process Development
Viral Vector R&D Production
We manufacture research and toxicology grade viral vectors that support preclinical studies, which include pilot, proof-of-concept, dose confirmation and IND-enabling toxicology studies.
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Plasmid Manufacturing
We manufacture research and toxicology grade plasmids, which support pilot, proof-of-concept, dose confirmation and IND-enabling toxicology studies. In 2022, we will be offering Phase I/IIa plasmid manufacturing services.
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We support clients through all phases of development and commercialization.
Our Patients Define Us
The name “Andelyn” was chosen to pay tribute to two brave young patients that participated in pivotal clinical trials that make today’s gene therapies possible.
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Updates from Andelyn
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Media Release
January 13, 2022
FDA Accepts GMP Plasmid DMF and Capacity Expansion Enabling Andelyn Biosciences to Offer Faster Gene Therapy Development
COLUMBUS, OH, January 13, 2022 – Andelyn Biosciences, a pioneering cell and gene therapy CDMO born out of Nationwide Children’s Hospital, today...
News
November 22, 2021
Nationwide Children’s Spinoff Andelyn Biosciences to Open New Lab in Dublin
Andelyn Biosciences has set its sights on Dublin for one of two new labs for the gene therapy company.
Blog
November 11, 2021
Leveraging Partnerships and a Unique History to Address Supply Chain and Capacity Challenges in Gene Therapy Manufacturing
Andelyn Biosciences has established a unique network of industry experts across the entire development and commercialization spectrum. In addition to...
Blog
October 22, 2021
Coping with a Talent Shortage and Talent War in Cell and Gene Therapy
Andelyn Biosciences is building the best cell and gene therapy team in spite of a talent shortage and competitive talent...
Our Employees Fuel Our Success
Andelyn is made up of an Inspired, Innovative and Compassionate team that contribute towards a rich company culture. We are always looking for great people who want to do great things.
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