The science works. The manufacturing doesn’t scale. That is the central tension in cell and gene therapy right now. More than 3,000 cell and gene therapy clinical trials are active worldwide. Over two dozen CGT products have received regulatory approval. And nearly $15 billion flowed into cell and gene therapy programs in 2025 alone. But for every breakthrough therapy that reaches patients, dozens more stall in development — not because the biology fails, but because manufacturing cannot keep up.
Viral vector production remains cumbersome and yields are poor. Autologous cell therapies require patient-specific manufacturing that is inherently difficult to scale. Quality control for living therapeutics is orders of magnitude more complex than for small molecule pills. And if you are a startup biotech that needs GMP manufacturing capacity today, getting into a queue at a qualified CDMO can take months.
This is why CDMOs — contract development and manufacturing organizations — have become the most critical infrastructure layer in advanced therapy development. And it is why the CDMO landscape has exploded from a handful of players a decade ago to more than 125 companies specializing in cell and gene therapy manufacturing today.
This guide profiles the 20 CDMOs that matter most in 2026 — the organizations that biotech companies are choosing to manufacture the next generation of medicines. Whether you are a biotech founder evaluating manufacturing partners, a BD executive negotiating CDMO contracts, or an investor assessing the picks-and-shovels opportunities in advanced therapies, this is your map.
This guide is updated quarterly. CDMOs are evaluated on manufacturing capabilities, regulatory track record, capacity investments, and client portfolio. Suggest a CDMO for review.
Why Manufacturing Is the Bottleneck
Three forces are colliding to make CDMO selection the most consequential operational decision in cell and gene therapy.
Demand is surging while capacity remains constrained. Spending on cell and gene therapy manufacturing reached $5.9 billion in 2023, an increase of 38% from the prior year. The number of CGT products in development continues to grow exponentially. But building new GMP manufacturing suites takes 18 to 36 months and tens of millions of dollars — meaning capacity always lags demand.
Regulatory complexity is increasing. Cell and gene therapies require manufacturing processes that meet standards from the FDA, EMA, PMDA, and other agencies simultaneously. Each product is unique, each manufacturing process is bespoke, and each regulatory submission requires exhaustive process characterization. CDMOs with proven regulatory track records — zero rejection histories — command premium pricing and longer wait lists.
The modality mix is expanding. A decade ago, CGT manufacturing meant primarily CAR-T and a handful of viral vector programs. Today, CDMOs must support AAV vectors, lentiviral vectors, mRNA, plasmid DNA, iPSC-derived therapies, exosomes, gene-edited cells, and entirely novel modalities. The CDMOs that can serve this expanding menu of technologies will capture disproportionate market share.
Tier 1: Global CDMO Leaders
These organizations operate at the largest scale, serve the broadest range of modalities, and have the deepest regulatory track records. They are the default manufacturing partners for large pharma and the most common choice for late-stage biotech programs approaching commercialization.
1. Catalent (Novo Holdings)
Headquarters: Somerset, NJ | Acquired by: Novo Holdings for $16.5 billion (2024)
Catalent’s acquisition by Novo Holdings — the investment arm of the Novo Nordisk Foundation — was the largest deal in CDMO history and fundamentally reshaped the advanced therapy manufacturing landscape. Catalent’s OneBio platform now integrates antibody and recombinant protein manufacturing, cell and gene therapy production, and mRNA capabilities under one roof. The company’s network of biologics manufacturing sites spans the United States, Europe, and Asia. New partnerships in 2024 included work with IsomAB for its antibody program and Siren Biotechnology for AAV immuno-gene therapies. Under Novo Holdings, Catalent is expected to accelerate capacity expansion and deepen its presence in the Novo Nordisk ecosystem — which includes the world’s largest GLP-1 franchise.
Key capabilities: Viral vectors (AAV, lentiviral), cell therapy, mRNA, biologics, fill/finish Best for: Late-stage and commercial programs needing large-scale, multi-modality manufacturing with global regulatory experience.
2. Lonza
Headquarters: Basel, Switzerland | Founded: 1897
Lonza is one of the most established and trusted names in pharmaceutical contract manufacturing. Their Ibex Solutions campus in Visp, Switzerland is among the most advanced biomanufacturing complexes in the world. Lonza’s CGT capabilities span viral vector production (AAV and lentiviral), cell therapy manufacturing, and commercial-scale biologics. Their decades of regulatory experience across FDA, EMA, and global agencies make them a preferred partner for programs approaching or in commercial manufacturing. Lonza’s investment in next-generation manufacturing technologies — including continuous processing and advanced analytics — positions them to maintain leadership as the complexity of therapies increases.
Key capabilities: Viral vectors, cell therapy, mammalian biologics, microbial expression, ADCs Best for: Programs requiring the highest level of regulatory confidence, commercial-scale manufacturing, and long-term partnership stability.
3. Samsung Biologics
Headquarters: Incheon, South Korea | Founded: 2011
Samsung Biologics operates the world’s largest biomanufacturing campus by total capacity. Their facilities in Incheon can produce biologics at a scale that few competitors can match, and the company continues to invest aggressively in capacity expansion. While Samsung Biologics is primarily known for large-molecule biologics manufacturing (monoclonal antibodies, biosimilars), they have been expanding into advanced therapy modalities. Their sheer scale makes them a critical partner for any sponsor whose therapy reaches commercial volumes that demand massive production capacity.
Key capabilities: Large-scale mammalian cell culture, monoclonal antibodies, biosimilars, ADCs Best for: Commercial-scale biologic manufacturing programs requiring massive capacity and proven operational reliability.
4. Thermo Fisher Scientific (PPD + Patheon)
Headquarters: Waltham, MA
Thermo Fisher’s CDMO capabilities — assembled through acquisitions including Patheon, PPD, and Brammer Bio ($1.7 billion acquisition) — create a uniquely integrated offering. Sponsors can access drug substance manufacturing, drug product fill/finish, clinical trial management, and analytical testing through a single organization. The Brammer Bio acquisition specifically built Thermo Fisher’s viral vector and gene therapy manufacturing capacity, making them a significant player in advanced therapies alongside their established strength in traditional biologics and small molecules.
Key capabilities: Viral vectors, gene therapy, biologics, sterile fill/finish, small molecules, analytical services Best for: Sponsors seeking integrated manufacturing + clinical services, programs requiring both drug substance and drug product under one CDMO, and companies that want access to Thermo Fisher’s broader analytical and laboratory ecosystem.
5. WuXi Advanced Therapies
Headquarters: Shanghai, China / Philadelphia, PA
WuXi Advanced Therapies — a specialized division of WuXi AppTec — has established itself as a leading CDMO in the cell and gene therapy space. The company is the manufacturing partner for several FDA-approved advanced therapies, including a CAR-T therapy from Autolus Therapeutics and a gene therapy from Orchard Therapeutics. Their capabilities span cell banking, scalable AAV production, lentiviral vector manufacturing, and advanced analytical testing. However, the U.S. BIOSECURE Act has introduced uncertainty for sponsors evaluating long-term partnerships with WuXi. While the company continues to expand its U.S. and European manufacturing footprint, sponsors should be aware of evolving geopolitical and regulatory dynamics.
Key capabilities: CAR-T manufacturing, viral vectors (AAV, lentiviral), plasmid DNA, cell banking, analytical testing Best for: Sponsors seeking cost-effective CGT manufacturing with proven FDA approval experience — with awareness of BIOSECURE Act implications.
Tier 2: Advanced Therapy Specialists
These CDMOs have built their business models specifically around cell and gene therapy manufacturing. They offer deep expertise in CGT modalities, dedicated facilities, and specialized teams that understand the unique complexity of manufacturing living medicines.
6. Minaris Advanced Therapies
Headquarters: Yokohama, Japan / Philadelphia, PA
Minaris was formed through the combination of Minaris Regenerative Medicine and WuXi Advanced Therapies’ legacy assets, creating one of the largest pure-play CGT CDMOs in the world. With comprehensive lentiviral and AAV platforms, a 140,000 square foot dedicated GMP testing facility in Philadelphia, and over 40 years of experience in biologics testing, Minaris provides end-to-end CGT manufacturing from early-stage development through commercial launch. Their GMP testing capabilities — supporting cell therapies, viral vectors, monoclonal antibodies, and vaccines — have achieved zero regulatory rejections across more than 3,000 studies. The company’s proprietary TESSA AAV and XOFLX lentiviral vector technologies offer differentiated production platforms.
Key capabilities: Cell therapy, viral vectors (AAV, lentiviral), GMP analytical testing, plasmid DNA, process development Best for: CGT developers seeking a pure-play advanced therapy CDMO with deep manufacturing expertise and a zero-rejection analytical testing track record.
7. AGC Biologics
Headquarters: Bothell, WA | Global Facilities: US, Europe, Japan
AGC Biologics has positioned itself as a multi-modality CDMO with particular strength in cell and gene therapies. The company has manufactured three commercially approved cell therapies and supplied more than 30 CGT clinical trials across the U.S. and EU. Their 160+ in-house analytical tests support both clinical and commercial supply. In March 2024, AGC manufactured the first FDA-authorized gene therapy for metachromatic leukodystrophy. Their expansion into Japan with a new cell therapy process development facility addresses growing demand for CGT manufacturing in Asia.
Key capabilities: Cell therapy, viral vectors (AAV, lentiviral, retroviral), mammalian biologics, microbial expression, plasmid DNA, fill/finish Best for: CGT sponsors needing a CDMO with commercially proven manufacturing capabilities and global reach across three continents.
8. FUJIFILM Diosynth Biotechnologies
Headquarters: Research Triangle Park, NC | Parent: FUJIFILM Holdings
Fujifilm Diosynth has invested heavily in advanced therapy manufacturing, including a massive new facility expansion in North Carolina. They serve as a manufacturing partner for some of the industry’s most advanced biologic and gene therapy programs. FUJIFILM Cellular Dynamics, a sister company, opened a $21 million cGMP production facility specifically for iPSC cell products — a growing modality with applications across regenerative medicine and cell therapy. The combined Fujifilm ecosystem provides manufacturing capabilities spanning biologics, gene therapy, and iPSC-derived therapies.
Key capabilities: Biologics, gene therapy (viral vectors), iPSC-derived therapies, microbial expression, process development Best for: Sponsors developing gene therapies, iPSC-derived cell products, or traditional biologics who want access to a CDMO backed by a large, stable parent company with aggressive capacity investment plans.
9. National Resilience (Resilience)
Headquarters: San Diego, CA | Founded: 2020 | Initial Funding: $2 billion+
Resilience was founded with a bold thesis: biomanufacturing infrastructure is a national security asset and needs to be reinvented. Backed by more than $2 billion in initial funding, Resilience acquired and built a network of manufacturing facilities purpose-designed for next-generation medicines — mRNA, gene therapies, cell therapies, and complex biologics. Their approach emphasizes manufacturing flexibility and rapid scale-up, capabilities that were painfully absent during the early pandemic response. Resilience’s facilities are designed with modular architectures that can be reconfigured for different product types faster than traditional fixed-purpose suites.
Key capabilities: mRNA, gene therapy, cell therapy, biologics, flexible/modular manufacturing Best for: Sponsors developing novel modalities who need a manufacturing partner built for flexibility, rapid response, and next-generation production architectures.
10. Oxford Biomedica
Headquarters: Oxford, UK | Founded: 1995
Oxford Biomedica operates at the intersection of CDMO services and proprietary gene therapy development. Their LentiVector platform is one of the most established lentiviral vector manufacturing systems in the industry, and the company was a critical manufacturing partner for the Oxford-AstraZeneca COVID-19 vaccine. Oxford Biomedica’s dual identity — as both a developer and manufacturer — gives them deep understanding of the challenges CGT sponsors face, because they face those same challenges with their own pipeline.
Key capabilities: Lentiviral vectors, AAV vectors, plasmid DNA, process development, commercial manufacturing Best for: Gene therapy sponsors who need a CDMO with world-class lentiviral vector expertise and deep understanding of CGT development challenges from their own pipeline experience.
11. Charles River Laboratories (CGT Division)
Headquarters: Wilmington, MA
Charles River’s acquisition of Cognate BioServices for $875 million signaled a strategic commitment to cell and gene therapy manufacturing. Their CGT division now provides CDMO services alongside Charles River’s established preclinical testing capabilities — creating a unique offering where sponsors can access manufacturing, quality testing, and preclinical services through a single partner. This integration is particularly valuable for early-stage programs where manufacturing process development and preclinical safety testing are happening in parallel.
Key capabilities: Cell therapy manufacturing, viral vector production, preclinical testing, analytical services Best for: Early-stage CGT developers who want integrated manufacturing + preclinical services from a single partner, reducing coordination complexity.
12. RoslinCT (formerly Roslin Cell Therapies + Lykan Bioscience)
Headquarters: Edinburgh, UK / Hopkinton, MA
The merger of UK-based RoslinCT and Massachusetts-based Lykan Bioscience created an international CDMO specializing in cell therapeutics with particular expertise in gene editing and iPSC capabilities. The combined entity provides process development and cGMP manufacturing for cell therapies across both sides of the Atlantic. Their iPSC specialization positions them for the growing wave of allogeneic cell therapies that could transform the economics of cell therapy by replacing patient-specific manufacturing with off-the-shelf products.
Key capabilities: Cell therapy (autologous and allogeneic), iPSC-derived therapies, gene-edited cell products, process development Best for: Cell therapy sponsors, especially those developing allogeneic or iPSC-based programs, who need a CDMO with deep cell processing expertise on both sides of the Atlantic.
Tier 3: Specialized and Emerging CDMOs
These CDMOs serve specific niches within the advanced therapy manufacturing landscape — from viral vector specialists to mRNA producers to emerging regional players. Their focused expertise often makes them the best choice for sponsors with specific manufacturing needs.
13. Aldevron (Danaher)
Headquarters: Fargo, ND | Acquired by: Danaher
Aldevron is the leading independent manufacturer of plasmid DNA, mRNA, and proteins for the gene therapy and vaccine industries. Plasmid DNA is a critical raw material for virtually every viral vector and mRNA manufacturing process — meaning Aldevron sits upstream of almost every CDMO on this list. Their 25 years of experience in nucleic acid manufacturing, combined with Danaher’s operational excellence, makes them an essential infrastructure partner for the entire CGT ecosystem. Aldevron supports clients from discovery through commercialization.
Key capabilities: Plasmid DNA, mRNA, recombinant proteins, GMP manufacturing Best for: Any sponsor needing high-quality plasmid DNA or mRNA starting materials for gene therapy, cell therapy, or vaccine programs.
14. Forge Biologics (Ajinomoto Bio-Pharma Services)
Headquarters: Columbus, OH | Acquired by: Ajinomoto for $620 million
Forge Biologics was acquired by Ajinomoto in a $620 million deal that reflected the strategic value of dedicated AAV manufacturing capacity. Their Gene Therapy Center of Excellence — “The Hearth” — is a purpose-built facility focused on AAV vector manufacturing from process development through commercial supply. The Ajinomoto acquisition brings additional resources and operational scale while maintaining Forge’s specialized focus on gene therapy.
Key capabilities: AAV vector manufacturing, process development, analytical testing, GMP production Best for: Gene therapy sponsors focused on AAV-based programs who need a dedicated, purpose-built manufacturing partner.
15. Ascend Advanced Therapies
Headquarters: Various | Focus: Gene-to-GMP
Ascend positions itself as a “gene-to-GMP” CDMO — covering the full spectrum from early discovery work through optimization, process development, regulatory support, and GMP manufacturing. This breadth of service is particularly valuable for early-stage companies that need help translating their laboratory-scale process into something that can produce clinical-grade material.
Key capabilities: Gene therapy, cell therapy, process development, regulatory support, GMP manufacturing Best for: Early-stage CGT developers who need a CDMO that can support the full journey from research-grade to GMP material.
16. IDT Biologika
Headquarters: Dessau-Rosslau, Germany
IDT Biologika is a global CDMO specializing in innovative vaccines, cell and gene therapeutics, and aseptic fill/finish of biologics. Their European manufacturing base provides an important geographic alternative for sponsors who want to manufacture within the EU regulatory framework. IDT’s vaccine manufacturing heritage gives them deep experience with complex biological products and regulatory agency inspections.
Key capabilities: Vaccines, cell and gene therapy, aseptic fill/finish, viral vector production Best for: Sponsors seeking European-based CGT manufacturing with strong vaccine and biologics heritage.
17. 3P Biopharmaceuticals (3PBIOVIAN)
Headquarters: Pamplona, Spain
3PBIOVIAN is a growing European CDMO supporting biologics and advanced therapies from early-stage development to commercial manufacturing. Their services span microbial and mammalian protein expression, viral vector production (AAV), cell therapy, and plasmid DNA manufacturing. As European regulatory requirements for CGT manufacturing continue to evolve, having a European-based CDMO with GMP capabilities that align with EMA expectations is increasingly valuable.
Key capabilities: AAV vectors, plasmid DNA, cell therapy, mammalian and microbial biologics Best for: European and global sponsors seeking EU-based advanced therapy manufacturing.
18. VectorBuilder
Headquarters: Chicago, IL / Guangzhou, China | Focus: Vector design and manufacturing
VectorBuilder occupies a unique niche as an online platform for designing and manufacturing custom viral vectors. Their platform enables vector design, custom cloning, and virus packaging across lentivirus, adenovirus, AAV, and other vector systems. For early-stage researchers and biotech companies, VectorBuilder provides accessible, fast-turnaround vector manufacturing that eliminates the need for in-house vector production capabilities.
Key capabilities: Custom vector design and cloning, lentiviral vectors, AAV, adenoviral vectors, virus packaging Best for: Early-stage researchers and biotech companies needing rapid, accessible viral vector manufacturing without building in-house capabilities.
19. Ori Biotech
Headquarters: London, UK | Focus: Manufacturing automation for cell therapies
Ori Biotech is not a traditional CDMO — they are building the manufacturing automation platform that CDMOs and cell therapy developers need to scale production. Their technology addresses the fundamental challenge in autologous cell therapy: each dose is manufactured individually from a specific patient’s cells, making it inherently difficult to scale with traditional manufacturing approaches. Ori’s platform automates and standardizes cell therapy manufacturing processes, reducing cost per dose, improving consistency, and enabling the kind of scale that the market demands.
Key capabilities: Cell therapy manufacturing automation, process standardization, manufacturing platform technology Best for: Cell therapy developers and CDMOs seeking manufacturing automation to reduce cost, improve consistency, and enable scale for autologous therapies.
20. Lotte Biologics
Headquarters: Incheon, South Korea | Founded: 2022
Lotte Biologics is one of the most aggressively expanding CDMOs in the world. Backed by the Lotte Group conglomerate, the company is investing more than $1.6 billion to build a massive biomanufacturing campus in Incheon, South Korea, with planned expansion into the U.S. Their focus spans monoclonal antibodies, ADCs (antibody-drug conjugates), and advanced therapies including cell and gene therapy. Lotte’s competitive advantage is its willingness to invest at massive scale while the market is still growing — a bet that they will capture significant share as global biologics demand continues to expand.
Key capabilities: Monoclonal antibodies, ADCs, cell and gene therapy (expanding), large-scale biologics Best for: Sponsors seeking a rapidly scaling manufacturing partner with aggressive capacity investment and competitive pricing, particularly those with programs targeting the Asia-Pacific market.
How to Choose a CDMO: The Critical Questions
Selecting a manufacturing partner for a cell or gene therapy is among the highest-stakes decisions a biotech company will make. The wrong choice can delay your program by years and cost tens of millions in wasted development work. Here are the questions that matter most:
What is your modality? CAR-T, AAV gene therapy, lentiviral gene therapy, mRNA, and iPSC-derived therapies each require different manufacturing platforms, different expertise, and different facility designs. Your CDMO must have proven experience with your specific modality, not just adjacent ones.
What phase are you in? Early-stage programs need a CDMO that excels at process development and can flexibly iterate on manufacturing protocols. Late-stage and commercial programs need proven scale-up capabilities, validated processes, and the capacity to meet commercial demand. These are often different organizations.
What is your regulatory strategy? If you are filing in the U.S. and EU simultaneously, your CDMO needs experience with both FDA and EMA requirements. If your therapy has received designations like RMAT, Breakthrough Therapy, or PRIME, your CDMO should understand the accelerated timelines and regulatory expectations those designations create.
What is your supply chain risk tolerance? Manufacturing cell and gene therapies in a single facility creates concentration risk. Programs with commercial ambitions should consider CDMOs with multiple manufacturing sites or those willing to support technology transfer to secondary sites.
What are the geopolitical considerations? The BIOSECURE Act and broader U.S.-China tensions mean that sponsors should carefully evaluate the long-term viability of manufacturing relationships with China-based CDMOs. Contingency planning is not optional.
The M&A Landscape: Who’s Buying Whom
The CDMO sector has been one of the most active M&A markets in biopharma. Understanding consolidation trends helps sponsors anticipate which CDMOs may change ownership — and what that means for ongoing programs.
Novo Holdings’ $16.5 billion acquisition of Catalent was the sector’s landmark deal, bringing one of the world’s largest CDMOs into the Novo Nordisk Foundation ecosystem. Ajinomoto’s $620 million acquisition of Forge Biologics reflected the premium that AAV manufacturing capacity commands. Thermo Fisher’s $1.7 billion acquisition of Brammer Bio built their viral vector capabilities. Charles River’s $875 million Cognate BioServices deal extended their reach into cell therapy manufacturing. And the merger of RoslinCT and Lykan Bioscience created a transatlantic cell therapy manufacturing powerhouse.
Expect consolidation to continue. CDMOs with proven regulatory track records, established client relationships, and capacity in high-demand modalities will command premium valuations. Sponsors should build manufacturing partnerships with an awareness that their CDMO partner may be acquired — and that the acquiring entity’s priorities may differ from the original partner’s.
What’s Next: Manufacturing Trends to Watch
Automation is coming to cell therapy. The fundamental challenge of autologous cell therapy — manufacturing a unique product for each patient — is being addressed by companies building automated, closed-system manufacturing platforms. This trend will reduce cost per dose, improve consistency, and make cell therapy accessible to more patients.
Continuous manufacturing for viral vectors. Traditional batch manufacturing of viral vectors is being supplemented by continuous processing approaches that improve yields, reduce facility footprint, and lower costs. CDMOs investing in continuous manufacturing will have structural advantages over those relying on legacy batch processes.
Reshoring to the U.S. and EU. Geopolitical uncertainty, supply chain vulnerabilities exposed during the pandemic, and government incentives are driving CDMO capacity investment in the U.S. and Europe. Sponsors should expect a more distributed global manufacturing footprint by 2028.
mRNA manufacturing scale-up. The mRNA modality, proven during the COVID-19 vaccine response, is expanding into oncology, rare disease, and protein replacement. CDMOs with mRNA manufacturing expertise are positioning for significant growth.
Methodology
CDMOs included in this guide were selected based on manufacturing capabilities and modality breadth, regulatory track record (agency inspections, approval history), capacity and investment trajectory, client portfolio relevance, and 2026 market activity. This guide does not include every CDMO serving the CGT market. It highlights the 20 organizations most relevant to biotech sponsors making manufacturing decisions in 2026.
Is your CDMO powering the next generation of advanced therapies? We update this guide quarterly and welcome submissions. Contact our editorial team with your company details for consideration in the next update.
Stay Ahead of Manufacturing Shifts
Manufacturing decisions made today determine which therapies reach patients in 2028 and beyond. The CDMO landscape is evolving faster than any other layer of the biotech infrastructure stack.
Subscribe to BioMed Nexus for daily coverage of CGT manufacturing developments, CDMO partnerships, and the operational insights that drive better development decisions.
Last updated: March 2026. Next update: June 2026.
