Our Capabilities
Andelyn Biosciences supports clients from preclinical concept to commercialization. We have supported more than 75 INDs with successful completion of over 450 cGMP clinical batches and over 2,000 research grade batches.
Partnering with you at every stage of the process.
As a biopharmaceutical CDMO collaborative partner, we offer our clients capabilities which span preclinical R&D, viral vector process and analytical development, small to large scale GMP manufacturing up to 2,000L, fill/finish and quality release testing. Plasmid manufacturing services for vertical integration, accelerated timelines and optimized production yields are offered at the research, toxicology and Phase I/IIa GMP grade.
From Phase I/IIa to Phase III to commercial manufacturing, Andelyn processes optimize production yields and accelerate timelines with scales ranging from 1L to 2,000L.
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.
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 manufacturing processes.
At Andelyn Biosciences, the thoroughness of our analytical development 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 the transfer of external assays and processes as well as moving assays and processes across facilities.
Andelyn's AAV 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 with data and analytics.
Facilities Driving Innovation and Breakthroughs
Explore the cutting-edge environments where innovation and quality meet. Andelyn Biosciences proudly operates three specialized facilities, each designed to support different stages of gene therapy development and manufacturing. Discover how our advanced infrastructure and strategic locations contribute to accelerating your path to market.
Rooted in Innovation
Addressing the Challenges of Today
Dive into the story of Andelyn Biosciences, where our journey from humble beginnings to a leader in gene therapy development unfolds. Our history is not just a record of our past, but a testament to our enduring commitment to pioneering solutions for the most challenging medical needs. Learn about our legacy and how we are advancing discoveries today.