Our Capabilities
Andelyn Biosciences supports clients from preclinical concept to GMP. We have supported more than 85 INDs with the successful completion of over 500 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 spanning 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 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.
Facilities Driving Innovation and Breakthroughs
Where innovation and quality meet, Andelyn proudly operates two specialized facilities, each designed to support different stages of gene therapy development and manufacturing. Discover how our advanced infrastructure and strategic locations accelerate your path to market.
Rooted in Innovation
Addressing the Challenges of Today
Dive into the story of Andelyn, where our journey from humble beginnings to a leader in cell and 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.
Frequently Asked Questions
Dive into the story of Andelyn, where our journey from humble beginnings to a leader in cell and 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.
How do you ensure product quality and compliance?
Andelyn builds quality into how we develop and manufacture gene therapies. Our unified cGMP Quality Management System supports clinical and commercial operations through change control, investigations, CAPA, document management, training, supplier quality, environmental monitoring, quality control, and validation activities.
We apply Quality by Design principles and science- and risk-based decision-making throughout the product lifecycle. Our facilities, utilities, systems, and equipment are qualified to meet applicable regulatory standards, and commercial-grade digital quality systems support our operations by providing unified data visibility, disciplined execution, and full traceability.
What is your approach to cost transparency?
We believe program visibility and proactive communication are essential to an effective manufacturing partnership. Through OneTeam™ program management, clients receive shared visibility into milestones, manufacturing status, technical results, key performance indicators, risks, and upcoming decisions.
Early cross-functional alignment helps establish program priorities, timing, roles, risk tolerance, and contracting approaches. This collaborative, milestone-driven model supports informed decision-making and minimizes surprises as programs advance.
Can you help with regulatory submissions?
Andelyn integrates regulatory readiness into program planning and commercial readiness activities. Our Regulatory Affairs team supports programs through the development lifecycle. In contrast, our technical, quality, and analytical teams generate the documentation, data packages, process understanding, and control strategies needed to support clinical and commercial milestones.
Our commercial readiness framework aligns process validation, analytics, raw materials, quality systems, regulatory considerations, and business operations. Andelyn operates an FDA-inspected facility and maintains a commercial-grade quality system designed to support clinical and commercial manufacturing.
How do you handle technology transfer?
Andelyn uses defined frameworks for both process and analytical technology transfer. Our teams assess the incoming process or assay, establish the transfer approach, and progress through appropriate small-scale, engineering, confirmation, and cGMP manufacturing activities based on program requirements.
We have experience transferring processes and assays across facilities and organizations for multiple modalities, including AAV and lentiviral vectors, as well as a range of cell lines, manufacturing processes, and analytical methods. Our integrated development and commercial facilities support a streamlined transition from preclinical work through commercial manufacturing.
What types of biologics do you support?
Andelyn Biosciences is a gene therapy CDMO supporting viral vector and plasmid programs from early development through commercial manufacturing. Our capabilities include AAV, lentiviral vector, plasmid, and select emerging technologies, supported by process development, analytical development, research and toxicology production, cGMP manufacturing, fill-finish, and commercial readiness services.
Our configurable AAV Curator® and LVV Curator® Platforms combine modular processes, Optimization-By-Design™, and data-driven decision-making to adapt each program to its specific product, scale, quality, and regulatory needs. We support programs from feasibility and preclinical work through clinical production, PPQ, and commercial supply.