Capabilities

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).

Clinical Manufacturing

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

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.

Andelyn Biosciences Viral Vector Core

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

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.

QC Lab

Quality Control

Guarantee Efficiency & Accuracy With Our Quality Control Laboratory Our Quality Control (QC) lab is equipped with top-of-the-line technology, and our trained personnel are always working to ensure that the products produced by Andelyn Biosciences are safe, meet desired quality metrics, and are