Capabilities Overview

Andelyn Biosciences supports clients from preclinical through Phase 3 trials. Late Stage/Commercial manufacturing facility will be operational in late 2022.

We are your full spectrum Gene Therapy partner, with capabilities for Viral Vector process and analytical development, small to large scale GMP manufacturing, Fill/Finish and quality release testing. We also offer plasmid manufacturing services and vector development (GMP, Tox grade and R&D).
Partnering with you at every stage of the process.
Clinical Manufacturing
From Phase I/IIA through Phase III, Andelyn’s goal is to provide our clients with a broad range of adherent and suspension based AAV viral vector manufacturing solutions.
Process Development
Process development is critical for the success of commercially-viable, safe gene therapy products. At Andelyn Biosciences, we use a set of rigorous process development guidelines like QbD, DoE and process characterization to establish, implement, and improve our AAV viral vector manufacturing processes.
Viral Vector Core
Andelyn Biosciences’ Viral Vector Core comprises of laboratory space reserved to manufacture research grade AAV vectors that support preclinical studies such as pilot, proof-of-concept, dose confirmation and IND-enabling toxicology studies.
Plasmid Manufacturing
Andelyn Biosciences has more than 20 years of experience in plasmid manufacturing, and we possess the capability and capacity to manufacture batches of plasmids in any size depending on client specifications – from small trials to clinical-scale plasmid production.
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Join our talented and passionate team.
At Andelyn, you can play a part in advancing medicine and saving lives.