Our Capabilities

From Phase I/IIa to Phase III to GMP manufacturing, Andelyn processes optimize production yields and accelerate timelines with scales ranging from 1L to 2,000L.

Andelyn has more than 20 years of experience in plasmid manufacturing, and we have the capability and capacity to manufacture batches of plasmids in any size, depending on client specifications – from small trials to clinical-scale plasmid production.

Process development is critical for the success of commercially viable, safe gene therapy products. At Andelyn, we use rigorous process development guidelines, such as QbD, DoE, and process characterization, to establish, implement, and improve our manufacturing processes.

At Andelyn, the thoroughness of our analytical development and quality control underpins our commitment to advancing gene therapy, ultimately ensuring the highest quality, safety, and efficacy of our products for those who depend on them the most.

Andelyn has extensive experience in both analytical and process tech transfers, including external assays and processes, as well as moving assays and processes across facilities.

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 by data and analytics.