World-Class Facilities
Where Design & Innovation Meet Purpose & Quality
Our facilities lead gene therapy manufacturing, fully aligning with today's US FDA and EMA industry standards and blending innovation, quality, and function. With two locations in Columbus, Ohio, our facilities are meticulously designed to support your cell and gene therapy program journeys from concept to commercialization. Explore the unique role each of our purposefully built centers plays in supporting client programs and advancing therapies from research to GMP and commercial manufacturing.
Andelyn Corporate Center
Step inside the Andelyn Corporate Center (ACC), our built-for-purpose gene therapy manufacturing facility designed to withstand the rigors of cell and gene therapy manufacturing. With the latest advances in construction, cleanroom technologies, and GMP-compliant design and operations, the facility is currently producing high-quality, GMP- and commercial-grade plasmids and viral vectors. Discover how our facility reliably advances life-saving therapies to market and how our role as a CDMO gene therapy partner supports sponsors from concept through commercialization.
Andelyn Development Center
Explore the Andelyn Development Center (ADC), where expert, precision-driven process development, preclinical manufacturing, and analytical capabilities converge for plasmids and viral vectors. As the cornerstone of Andelyn’s extensive gene therapy experience, the ADC powers cell and gene therapy manufacturing with scalable upstream and downstream platforms. It sits at the heart of our innovation, meeting the evolving demands of client programs and demonstrating how a CDMO gene therapy organization can integrate development and GMP readiness within our gene therapy manufacturing facilities.
Upholding the Highest Standards
In the rapidly evolving landscape of gene therapy manufacturing, adherence to stringent compliance and accreditation standards is a cornerstone of our operation. We maintain an unwavering dedication to regulatory excellence, ensuring every aspect of our process meets the highest industry and governmental standards. Our facilities are benchmarks of quality and safety in gene therapy production. Through rigorous oversight, continuous improvement, and transparent practices, our CDMO gene therapy services provide trust in processes, products, and people across every gene therapy manufacturing facility we operate.
Ushering a Safer, Greener Future in Gene Therapy
Sustainability and safety are integral to our mission of transforming lives through gene therapy. We integrate eco-friendly practices and safety protocols into every facet of operations, from reducing water and solution waste with single-use technologies to minimizing environmental footprint while ensuring worker and community safety. Our proactive approach to environmental stewardship and workplace safety supports responsible cell and gene therapy manufacturing within each gene therapy manufacturing facility.
Frequently Asked Questions
What is a gene therapy manufacturing facility?
A gene therapy manufacturing facility is a specialized cGMP-compliant site that produces genetic medicines, including plasmids, viral vectors (e.g., AAV, lentivirus), and other components, under strict quality, safety, and regulatory controls. Within this gene therapy manufacturing facility, operations are organized into controlled cleanroom suites with unidirectional flow, support areas for materials and equipment, and quality systems to ensure consistency and traceability in cell and gene therapy manufacturing.
How are gene therapies manufactured?
Gene therapies are manufactured through a series of upstream and downstream processes. Upstream, manufacturers culture host cells and transfect or transduce them to produce the therapeutic vector or material. Downstream, manufacturers harvest, clarify, purify (often via chromatography and ultrafiltration/diafiltration), formulate, store bulk drug substance or fill the product. Throughout cell and gene therapy manufacturing, process controls, batch records, and validated methods guide each step. As a CDMO gene therapy provider, Andelyn integrates development, scale-up, and tech transfer to ensure reproducible performance from preclinical through commercial manufacturing in our gene therapy manufacturing facility.
What equipment is needed in a gene therapy manufacturing facility?
Core upstream/cell culture equipment includes single-use bioreactors, incubators, biosafety cabinets, and controlled storage for critical raw materials. Downstream suites include depth and sterile filtration systems, chromatography skids, ultracentrifugation, tangential flow filtration units, and aseptic fill-finish isolators. Analytical labs employ qPCR/ddPCR, ELISA, HPLC/UPLC, GC, cell-based potency assays, and electron microscopy as required. This equipment mix enables robust CDMO gene therapy services, supporting process development, cGMP production, and release testing within the same gene therapy manufacturing facility.
What are the cleanroom requirements for gene therapy production?
Cleanroom requirements typically include ISO-classified environments with controlled air changes, HEPA filtration, pressure differentials, and environmental monitoring for viable and non-viable particulates. Personnel gowning, material flow, and segregation of pre- and post-viral operations are essential. The gene therapy manufacturing facility must maintain product campaign strategies to prevent cross-contamination, all aligned with cGMP expectations for cell and gene therapy manufacturing.
How is quality controlled and assured in gene therapy manufacturing?
Quality control relies on validated analytical methods and rigorous oversight. Release testing can include identity, purity (residual DNA/protein), potency, safety (bioburden, endotoxin, sterility), and vector genome titer. In-process controls confirm consistency at critical steps, and stability programs support shelf life. Our overall Quality Assurance systems manage deviations, CAPA, change control, and supplier qualification. As a CDMO gene therapy partner, Andelyn performs comprehensive QC and QA across development and cGMP operations in our gene therapy manufacturing facility to ensure compliant, high-quality outcomes.