Our Capabilities
Andelyn Biosciences, a gene therapy CDMO, supports clients from preclinical concept through GMP. We have supported more than 85 INDs, successfully completed over 500 cGMP clinical batches and over 2,000 research-grade batches, and delivered integrated gene therapy process development and AAV manufacturing CDMO solutions alongside GMP plasmid production.
Partnering with you at every stage of the process.
As a biopharmaceutical CDMO collaborative partner, we offer 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.
Our gene therapy CDMO services include plasmid manufacturing for vertical integration, accelerated timelines, and optimized production yields at research, toxicology, and Phase I/IIa GMP grades. With gene therapy process development and AAV manufacturing CDMO expertise, we align development and manufacturing with program needs, including GMP plasmid production to ensure end-to-end supply continuity.
From Phase I/IIa to Phase III to GMP manufacturing, Andelyn's process optimizations increase production yields and accelerate timelines, with scales ranging from 1L to 2,000L. Our AAV manufacturing CDMO capabilities are designed to support clinical and commercial supply through robust gene therapy CDMO services and comprehensive gene therapy process development.
Andelyn has more than 20 years of plasmid manufacturing experience and the capability and capacity to produce plasmid batches of any size, from small trials to clinical-scale production, based on client specifications. Our GMP plasmid production integrates seamlessly with upstream viral vector workflows, ensuring consistent quality and timelines for gene therapy CDMO services. We provide GMP plasmid production and related testing to de-risk AAV program supply.
Process development is critical for the success of commercially viable, safe gene therapy products. At Andelyn, we use rigorous gene therapy process development guidelines, such as QbD, DoE, and process characterization, to establish, implement, and improve our manufacturing processes. These gene therapy CDMO services ensure scalable, reproducible performance across development stages and into commercial manufacturing.
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. Our gene therapy CDMO services include validated assays, release testing, and stability programs aligned to AAV manufacturing CDMO requirements.
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. Our structured approach links gene therapy process development outputs with cGMP execution, supporting seamless AAV manufacturing CDMO transitions.
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, supporting gene therapy CDMO services from feasibility to commercial readiness.
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 through integrated AAV manufacturing CDMO operations and GMP plasmid production capacity.
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 through comprehensive gene therapy CDMO services and gene therapy process development.
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.
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 and lentiviral vectors, plasmids, and select emerging technologies.
Our configurable AAV Curator® and LVV Curator® Platforms integrate modular processes, Optimization-By-Design™, and data-driven decision-making to tailor each program to the specific product, scale, quality, and regulatory needs. We support programs from plasmid production and feasibility and preclinical work through clinical production, PPQ, and commercial supply, with an integrated AAV manufacturing CDMO.
How do you handle tech transfer?
Andelyn uses defined frameworks for both process and analytical technology transfer. Our teams assess the incoming process or assay, establish the transfer approach, develop protocols, and advance through appropriate small-scale, engineering, confirmation, and cGMP manufacturing activities aligned with program requirements. We incorporate gene therapy process development support as needed, rather than requiring it for every transfer.
We have experience transferring processes and assays across facilities and organizations across 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 technology transfer at different stages of the product lifecycle, backed by GMP-compliant plasmid production and AAV manufacturing capacity.
Can you help with regulatory submissions?
Andelyn integrates regulatory readiness into program planning and commercial readiness activities. Our experienced team supports programs throughout the development lifecycle, while our technical, quality, and analytical teams produce the documentation, data packages, process understanding, and control strategies needed to support clinical and commercial milestones across our gene therapy CDMO services.
Our commercial readiness framework aligns process validation, analytics, raw materials, quality systems, regulatory considerations, and business operations. Andelyn operates an FDA-approved facility and maintains a commercial-grade quality system that supports clinical and commercial manufacturing across AAV workflows.
What is your approach to program transparency?
We believe program visibility and proactive communication are essential to an effective manufacturing partnership. Through OneTeam™ program management, clients gain shared visibility into milestones, manufacturing status, technical results, key performance indicators, risks, and upcoming decisions. This model provides clarity across gene therapy process development, GMP plasmid production scheduling, and AAV manufacturing. Challenges are openly discussed and addressed collaboratively with the client.
Early cross-functional alignment helps set program priorities, timing, roles, risk tolerance, and contracting approaches. This collaborative, milestone-driven model supports informed decision-making and minimizes surprises as programs progress.
How do you ensure product quality and compliance?
Andelyn builds quality directly into gene therapy development and manufacturing. Our unified cGMP Quality Management System supports clinical and commercial operations across core compliance areas, including change control, investigations, CAPA, document management, and training. It also integrates rigorous supplier quality, environmental monitoring, quality control, and validation. Together, these systems enable consistent execution and dependable outcomes across all AAV programs.
We apply Quality-by-Design principles and science- and risk-based decision-making throughout the product lifecycle. Our facilities, utilities, and equipment comply with all applicable regulatory standards. In addition, commercial-grade digital quality systems support our daily operations by providing unified data visibility, disciplined execution, and complete traceability.
What is the difference between a CDMO and a CRO for gene therapy?
A CDMO performs development and manufacturing activities, from gene therapy process development to GMP-compliant AAV manufacturing, for clinical and commercial supply. A CRO focuses on research or clinical operations (e.g., studies, data management) rather than cGMP manufacturing. Gene therapy CDMO services bridge development and supply, while CROs support non-manufacturing aspects.
How much do gene therapy CDMO services cost?
Costs vary by scope, scale (1L to 2,000L), platform fit, analytical requirements, timeline, and clinical stage. Budgets typically include gene therapy process development, toxicology-stage production, materials (such as plasmid production), engineering runs, cGMP batches, and testing, storage, and shipping. Transparent planning and milestone-based pricing help align AAV manufacturing CDMO activities with program needs.
How do I choose a gene therapy CDMO service provider?
Select an end-to-end gene therapy CDMO with proven AAV manufacturing expertise, including in-house GMP-compliant plasmid production, integrated process development, and robust analytics. Evaluate demonstrated IND support and a proven cGMP batch history to advance your clinical phases, then assess scalability to 2,000L and supply chain stability for commercial volume. Finally, ensure the partner brings comprehensive quality systems, transparent program management, and regulatory experience to support FDA submissions, inspections, and the path to product approval.
What does a gene therapy CDMO do?
A gene therapy CDMO partners with a client to design, develop, manufacture, test, and release gene therapy materials, including AAV vectors and plasmids, to deliver advanced therapies to patients. Services span gene therapy process and analytical development, technology transfer, AAV manufacturing at all scales, fill/finish, and plasmid production to support development, clinical, and commercial programs.
What services are included in gene therapy CDMO offerings?
Typical offerings include preclinical support, gene therapy process development, plasmid DNA production (including GMP-compliant plasmid production), adherent and suspension AAV manufacturing at multiple scales, analytical development, fill/finish, QC release testing, stability, PPQ, dedicated program management, and commercial readiness. These gene therapy CDMO services also include tech transfer and regulatory documentation support.
What is your approach to program transparency?
We believe program visibility and proactive communication are essential to an effective manufacturing partnership. Through OneTeam™ program management, clients gain shared visibility into milestones, manufacturing status, technical results, key performance indicators, risks, and upcoming decisions. This model provides clarity across gene therapy process development, GMP plasmid production scheduling, and AAV manufacturing. Challenges are openly discussed and addressed collaboratively with the client.
Early cross-functional alignment helps set program priorities, timing, roles, risk tolerance, and contracting approaches. This collaborative, milestone-driven model supports informed decision-making and minimizes surprises as programs progress.
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.
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.
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.
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.