Andelyn Biosciences

Activities: Manufacturing Research & Development

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.

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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 Curator® 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.

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Related Content

Regulatory

Andelyn Biosciences strengthens CDMO credentials with full ICMC certification

The certification received by Andelyn underscores their long-standing commitment to quality, operational readiness, and client service as the company supports innovators in advancing gene therapies from development through clinical and commercial manufacturing
Manufacturing

Andelyn Biosciences launches LVV Curator platform, bringing proven viral vector platform pedigree to Lentiviral Vector manufacturing for cell therapies

New platform leverages the established Curator platform methodology to industrialise Lentivirus processes from concept to clinic
Manufacturing

Andelyn Biosciences and ENCell partner to create US-APAC gene therapy manufacturing corridor

The company has signed a collaboration agreement with South Korea's ENCell to establish a dual-hemisphere manufacturing platform linking US and Asia-Pacific facilities, enabling in-country production for regional clinical trials
Manufacturing

Andelyn and Tern Therapeutics partner for late-stage process performance qualification of a treatment of CLN2 Batten disease

This collaboration reflects Andelyn’s broader mission to accelerate gene therapies from preclinical through commercial readiness
Research & Development

Andelyn and Amplo Biotechnology to manufacture gene therapies for diseases affecting the neuromuscular junction

The partnership reflects a shared commitment to advancing the development and improving access to life-changing therapies
Manufacturing

One family’s journey from diagnosis to gene replacement therapy

How the Krueger family, supported by clinicians, researchers, and manufacturers, accelerated a novel treatment for ultra-rare NEDAMSS in just 14 months
Cell & Gene Therapy

The challenges and trends in gene therapy

Three perspectives on the challenges and trends in gene therapy
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