Biologics Drug Substance CDMOs

Intravacc

Netherlands

Intravacc is a Netherlands-based vaccine CDMO founded in 2013 with ~200 employees, specializing in vaccine development from discovery through Phase II clinical trials. The company provides cGMP manufacturing of bacterial, viral, conjugate, and oncological vaccines using mammalian and microbial fermentation systems (up to 200L single-use bioreactors), along with comprehensive analytical services and proprietary vaccine platforms including Outer Membrane Vesicle (OMV) technology.

JCR Pharmaceuticals

Japan

JCR Pharmaceuticals is a Japanese pharmaceutical company and CDMO founded in 1975, with nearly 50 years of experience in rare disease treatments and orphan drug production. Selected for Japan's Regenerative Medicine CDMO Subsidy Program in 2025, the company is expanding biomanufacturing infrastructure for cell, gene, and regenerative medicine therapies. JCR operates five production sites and has proprietary platforms including JUST-AAV for gene therapy and J-Brain Cargo for blood-brain barrier penetration.

JOINN Biologics

China

JOINN Biologics is a full-service biologics CDMO providing end-to-end development and manufacturing services for complex biologics modalities. Led by US-based development and management leadership, the company operates multi-site facilities in Richmond and Sacramento, California, and acquired Lonza's 183,000 sq ft manufacturing facility in Guangzhou, China. JOINN Biologics is integrated with its sister CRO, JOINN Labs, offering a seamless CRO-CDMO platform.

Laurus Synthesis

India

Laurus Synthesis is the CDMO subsidiary of Laurus Labs, a prominent Indian pharmaceutical and biotechnology company. It is a Contract Development and Manufacturing Organization with a solid track record in supporting drug development and commercial API supply. Serves as the US-affiliate of Laurus Labs, with key markets in the US, European Union, and Japan. Offers high-potent drug manufacturing capabilities and comprehensive CDMO services from drug substance development through commercial manufacturing.

Lonza

Switzerland

Lonza is a pioneer and world leader in the CDMO industry, founded in Switzerland in 1897. The company provides integrated development and manufacturing services across biologics, small molecules, cell and gene therapy, mRNA, and bioconjugates (ADCs/HPAPIs). With over 20,000 employees across five continents, Lonza serves the global pharmaceutical, biotech, and nutrition industries with end-to-end capabilities from early development to commercial-scale manufacturing.

Menarini Biotech

Italy

Menarini Biotech is a CDMO within the Menarini Group, specialized in process development and GMP manufacturing of biopharmaceuticals. Headquartered in the greater Rome area (Pomezia, Italy), the company has over 25 years of experience in biologics development and manufacturing, including monoclonal antibodies. Menarini Biotech provides services from cell line development through commercial-scale GMP production at its Italian pharmaceutical campus.

Novartis Contract Manufacturing

Austria

Novartis Contract Manufacturing is the CDMO arm of Novartis, offering fully integrated end-to-end manufacturing solutions across biologics (mammalian up to 15,000L, microbial up to 13,000L), small molecules (API to fill & finish), cell & gene therapy (CAR-T, AAV, LV), xRNA/LNP/pDNA, and comprehensive fill & finish services. The operation spans multiple state-of-the-art facilities across Austria, Switzerland, Slovenia, Belgium, France, Singapore, and the United States, with 107 FDA inspections and 27 FEI registrations.

Pace® Life Sciences

United States

DUPLICATE ENTRY -- This is the same company as 'Pace Analytical Services LLC (Pace Life Sciences)' (company index 10). Pace Life Sciences is the CDMO/CRO division of Pace Analytical. Same website content, same capabilities. See company index 10 for full profile.

Panacea Biotec Ltd.

India

Panacea Biotec Ltd. is an Indian biotechnology company engaged in research, development, manufacturing, and marketing of branded pharmaceuticals and vaccines. The company has a USFDA-approved manufacturing facility at Baddi and WHO prequalified operations. Panacea Biotec also offers contract manufacturing services for pharmaceuticals and has been involved in COVID-19 vaccine manufacturing agreements. Listed on Indian stock exchanges.

Pfizer CentreOne

Belgium

Pfizer CentreOne is a global CDMO embedded within Pfizer, specializing in commercial manufacturing of oral solid doses, sterile injectables, biologics including monoclonal antibodies, and antibody-drug conjugates. It leverages Pfizer's global manufacturing network across six continents with cGMP-compliant sites and over 170 years of pharmaceutical manufacturing expertise, backed by $1B+ annual manufacturing investments.

Pharmaron

China

Pharmaron is a premier life science CRO/CDMO providing comprehensive R&D and manufacturing services across the entire drug discovery to commercialization process. The company serves small molecules, biologics, ADCs, cell & gene therapies, and protein degraders. It offers laboratory services, chemistry/manufacturing/controls (CMC), clinical development, and biologics/CGT manufacturing. Pharmaron acquired a commercial API manufacturing facility in the UK and operates a gene therapy CDMO in Liverpool with a 20-year track record. The company has over 20 years of experience across 7+ facilities in the UK, US, and China.

Pierre Fabre (CDMO)

France

Pierre Fabre CDMO is the contract development and manufacturing arm of the Pierre Fabre Group, a French pharmaceutical and dermo-cosmetics company. Offers over 20 years of CDMO services across pharma and non-pharma active ingredients, dry forms, non-sterile liquids, and biologics including monoclonal antibodies and ADCs. Operates R&D site in Toulouse and 3+ industrial sites in France. Expertise spans extraction, chromatographic purification, chemical synthesis, cytotoxic compound production, plant cell culture, and supercritical CO2 technology. Manufactures 2,100 metric tons of plant extracts and 100+ active ingredients annually.

Polpharma / Polpharma API

Kazakhstan

Polpharma is the leader of the Polish pharmaceutical market and one of the leading drug manufacturers in Central and Eastern Europe, with origins dating to 1935. Produces 400 million packages annually across 5 manufacturing plants and 3 R&D centers. The group includes Polpharma API (CDMO/API manufacturing), Polpharma Biologics (state-of-the-art biologic manufacturing including biosimilars and innovative molecules), and Farmaprojects (B2B hub). Has received grants for RNA-based medicines development under the STEP initiative. FDA registered for API manufacture.

Porton Advanced Solutions

China

Porton Advanced Solutions is a China-based CRO and CDMO specializing in Advanced Therapy Medicinal Products (ATMPs). They provide end-to-end services from cell banking, process and analytical method development, GMP production, to fill and finish. Their platforms include lentivirus (for CAR-T, TCR-T, CAR-NK), plasmid DNA (supercoiled, linear, LcDNA), mRNA and LNP encapsulation, AAV, and bacterial vectors. They have achieved 18 IND approvals across NMPA (13), FDA (4), and MedSafe (1), with 300+ GMP batches and 200+ GMP IITs batches produced.

Porton Pharma Solutions

China

Porton Pharma Solutions is a global CDMO headquartered in China with over 4,300 employees and operations in the US, Europe (Slovenia), and China. They offer end-to-end services across small molecules, tides (peptides/oligonucleotides), biologics and conjugates (ADCs), and advanced therapy medicinal products. Technical solutions include crystallization, bio catalysis, metal catalysis, flow chemistry, preparative chromatography, milling, and chemical engineering. FDA-registered with 4 FEI numbers for API manufacture, they have 3 FDA inspections with clean outcomes (1 NAI, 2 VAI).

Premas Biotech

India

Premas Biotech is an Indian biologics-focused CDMO based in Gurugram, Haryana, with 150+ employees. They specialize in recombinant protein expression and manufacturing across multiple host systems: bacterial (E. coli), yeast (S. cerevisiae, Pichia pastoris), and mammalian (CHO-DG44). They have proprietary technology platforms including D-CRYPT (difficult-to-express proteins), AXTEX-4D (4D cell culture for oncology drug screening), and C-QWENCE (naive human phage scFv antibody library). Services span cell line development, scouting, process development, scale-up and GMP manufacturing, and analytical development with functional assays. They have delivered 650+ proteins with scale-up to 100L+ volumes and capacity to deliver grams to kilograms. Received a Gates Foundation grant for rotavirus vaccine development. Joint venture Oravax Medical (with Oramed Pharmaceuticals) for oral COVID-19 vaccine development using VLP technology.

ProBioGen AG

Germany

ProBioGen AG is a fully integrated CDMO headquartered in Berlin, Germany, specializing in the development and GMP manufacturing of biopharmaceuticals, viral vectors, and vaccines. The company offers cell line development, process development, GMP manufacturing up to 1000L bioreactors, and comprehensive analytical services. ProBioGen leverages proprietary technologies including GlymaxX (ADCC enhancement), DirectedLuck (transposase system), and CHO.RiGHT production systems.

Profacgen

United States

Profacgen is a US-based protein services and biologics CDMO headquartered in Shirley, New York. The company provides custom protein expression, protein analysis, drug development services, and cGMP-compliant biopharmaceutical manufacturing from a 25,000 sq ft GMP and GLP-compliant facility. Profacgen offers end-to-end CDMO support for biologics including feasibility assessment, process development, cGMP manufacturing, and regulatory filing support.

Rentschler Biopharma

Germany

Rentschler Biopharma is a leading global CDMO focused exclusively on biopharmaceuticals, with over 50 years of industry experience. The company contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023, has supported 180+ biotherapeutics, and serves 180+ clients worldwide. It is an independent family-owned company employing approximately 1,400 people.

SK bioscience

South Korea

SK bioscience is a South Korean vaccine-focused biopharmaceutical company that also operates as a CDMO. Listed on KOSPI (302440), they develop proprietary vaccines (influenza, varicella, COVID-19, pneumococcal, HPV, RSV) and provide CDMO/CMO services for vaccine manufacturing. They acquired a controlling stake in German CDMO IDT Biologika for approximately $244M, gaining manufacturing sites in Dessau (Germany) and Rockville (Maryland, USA). SK bioscience collaborates with the Bill & Melinda Gates Foundation, CEPI, and international vaccine initiatives. They have WHO prequalified products.

Syngene International

India

Syngene International is a leading Indian Contract Research, Development and Manufacturing Organization (CRDMO) that provides integrated services spanning drug discovery through commercial manufacturing for both small and large molecules. The company has long-term research collaborations with Bristol Myers Squibb (extended until 2035) and Amgen. Syngene recently opened its first US manufacturing facility in Rockville, Maryland, and added a bioconjugation suite in Bengaluru for end-to-end ADC development. The company has 20 kL single-use drug substance capacity for biologics.

SyVento BioTech

Poland

SyVento BioTech is a Polish biotechnology CDMO specializing in lipid-based nanocarrier formulations and LNP (lipid nanoparticle) technology for mRNA-based drug products. They offer comprehensive CDMO services for pharma and biotech innovators, covering mRNA synthesis and LNP encapsulation. The company opened a new mRNA manufacturing facility (FlexFactory by Cytiva) spanning over 7,000 m2 including lab and production areas. They have partnerships with Cytiva and signed a Letter of Intent with Mabion S.A. for biologics manufacturing collaboration.

Tanvex Biopharma USA, Inc

Taiwan

Tanvex BioPharma USA is a vertically-integrated biopharmaceutical company that has launched a CDMO division (Tanvex CDMO) offering pre-clinical through commercial-scale contract manufacturing of microbial and mammalian-derived biotherapeutics. Founded by Dr. Allen Chao (former founder/CEO of Watson Pharmaceuticals). They received FDA approval for Nypozi (biosimilar filgrastim) and have an FDA-accepted biosimilar BLA. The CDMO offers end-to-end biologics manufacturing services. Their San Diego facility is FDA-registered with 1 approved product (injectable). They have capabilities in both biosimilar development and contract manufacturing for third parties.

Thermo Fisher Scientific Inc.

China

One of the world's largest pharmaceutical CDMOs through its Patheon pharma services division. Provides end-to-end pharmaceutical development and manufacturing services for both small molecules and biologics, from API manufacturing through drug product, sterile fill/finish, packaging, and commercial supply. Operates 31+ FDA-registered facilities globally. 158 FDA inspections on record (52 NAI, 104 VAI, 2 OAI). Also provides cell therapy manufacturing solutions (CTS Rotea cell processing system), laboratory informatics, bioprocessing equipment, and reagents. 4 FDA-approved drug products. Revenue >$40B (full company).

VintaBio

United States

VintaBio is a US-based viral vector CDMO that recently emerged from stealth, specializing in simplified viral vector manufacturing for gene therapies. The company claims 60% reduction in process time, 30% reduction in raw material costs, 5x increase in high-purity vector production, and 90% full capsids through its proprietary VintaProcess technology. Team has 120+ years of combined cell and gene therapy experience. Recently opened a custom-built manufacturing facility in Philadelphia.

Viralgen

Spain

Viralgen is a premier CDMO specializing exclusively in AAV-based gene therapy manufacturing, founded in 2017 as a subsidiary of AskBio within the Bayer AG group. Claims the world's largest manufacturing capacity dedicated to AAV. Operates from a cGMP facility in San Sebastian, Spain with bioreactors up to 2,000L. Offers end-to-end services from early construct optimization to commercial campaigns. 50+ clients across US, Europe, Asia, and Australia. 10+ years of lentiviral/AAV experience. 200+ batches in bioreactor. 130+ employees. 7 dedicated cleanrooms. Proprietary TESSA technology platform (from AskBio).

ViroCell Biologics

United Kingdom

ViroCell Biologics is a UK-based CDMO specializing exclusively in the design, optimization, and GMP manufacturing of lentiviral and retroviral vectors for clinical trials. Described as the UK's first clinical trial-focused viral vector manufacturer. Operating from a facility at Great Ormond Street Hospital in London, the company focuses on innovation-driven viral vector design, de-risking, and delivery. The facility reportedly more than doubles Britain's viral vector manufacturing capacity.

Wacker Biotech

Germany

Wacker Biotech is the CDMO division of Wacker Chemie AG, specializing in advanced biologics manufacturing including proteins, plasmid DNA, mRNA, LNP formulations, live microbial products, and vaccines. With over 30 years of experience and five GMP-compliant facilities in Germany, the Netherlands, and the United States, Wacker Biotech offers process development through commercial-scale manufacturing with E. coli-based technology platforms.

Waisman Biomanufacturing

United States

Waisman Biomanufacturing is an academic CDMO based at the Waisman Center at the University of Wisconsin-Madison, specializing in advancing novel biologics and vaccines into early clinical trials. The facility manufactures plasmid DNA, recombinant proteins, cell therapeutics, extracellular vesicle/secretome products, live biotherapeutic products, and viral vectors under cGMP conditions.

Wheeler Bio

United States

Wheeler Bio is a biologics CDMO based in Oklahoma City, specializing in accelerating antibody-based therapeutics from discovery to cGMP clinical supply. The company uses its proprietary Modular CMC approach to reduce risk and accelerate timelines for drug developers. Wheeler Bio offers cell line development, process development, analytics, and manufacturing services for monoclonal antibodies, bispecific antibodies, and fusion proteins.

WuXi Biologics

China

WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) for biologics, with over 12,000 employees across the US, Ireland, Germany, China, and Singapore. The company provides end-to-end solutions from discovery through commercial manufacturing for biologics including monoclonal antibodies, bispecifics, ADCs, vaccines, and mRNA products using both mammalian and microbial expression systems.

Xellia Pharmaceuticals

China

Xellia Pharmaceuticals is the global leader in fermentation-based non-beta-lactam anti-infective APIs and finished dosage forms (FDFs). With over 120 years of pharmaceutical manufacturing heritage, they supply APIs and sterile injectables to over 500 pharmaceutical companies across 80 countries. Also operates as a CMO for third-party sterile injectable production.

Yposkesi (an SK pharmteco company)

France

Yposkesi, an SK pharmteco company, is one of Europe's largest Contract Development and Manufacturing Organizations (CDMO) for gene therapy viral vector manufacturing. Based near Paris (Evry-Courcouronnes), the company provides end-to-end gene therapy CDMO services including process development, cGMP manufacturing, analytical testing, and regulatory support for AAV, lentivirus, and other viral vectors.

Zydus Lifesciences Ltd

India

Zydus Lifesciences Ltd. (formerly Cadila Healthcare) is a major Indian pharmaceutical company headquartered in Ahmedabad, Gujarat, ranked 4th in the Indian pharma industry with 29,000+ employees globally. In June 2025, Zydus entered the global biologics CDMO business by acquiring Agenus Inc.'s U.S. manufacturing facilities in Emeryville and Berkeley, California for $75M upfront (plus $50M milestones), now operating as independent subsidiary Zylidac Bio LLC. These facilities provide end-to-end biologics development and manufacturing from pre-clinical to commercial stages, including monoclonal antibody manufacturing for Phase-3 immuno-oncology products (Botensilimab and Balstilimab). Zydus has 15 FDA-registered facilities, 156 FDA-approved products across capsules, tablets, creams, gels, injectables (including liposomal), ointments, suppositories, and transdermal patches. They have 58 FDA inspections (25 NAI, 28 VAI, 5 OAI) and 51 recalls (2 Class I, 40 Class II, 9 Class III). Manufacturing sites span Gujarat, Maharashtra, Goa, Himachal Pradesh, Sikkim (India), plus US (Vermont, Pennsylvania, Missouri) and Brazil. Their CDMO services are specifically the biologics arm through Zylidac Bio -- the broader Zydus business is primarily own-brand generic pharmaceuticals.

Akron Biotech

United States

Akron Biotech is a leading contract manufacturing organization (CMO/CDMO) providing cGMP-compliant solutions for cell and gene therapy. The company manufactures cytokines, growth factors, media, buffers, and transfection/transduction reagents, and recently expanded to a second 60,000 sq ft biologics manufacturing facility in Sarasota, Florida, to support growing demand for ancillary materials in cell and gene therapy.

Aldevron

United States

Aldevron is a US-based CDMO specializing in manufacturing plasmid DNA, mRNA, and related products for gene therapy, cell therapy, gene editing, and RNA vaccines/therapeutics. The company offers custom and catalog products from research grade through cGMP, with capabilities including mRNA production with LNP encapsulation and fill/finish, supporting discovery through commercialization.

Andelyn Biosciences

United States

Andelyn Biosciences is a gene therapy and viral vector CDMO with deep expertise in the development and production of viral vectors. The company has produced 450+ cGMP clinical batches, supported 75+ INDs, and operates 225,000+ sq ft of facility space. Andelyn offers viral vector manufacturing, plasmid manufacturing, process development, and laboratory services, with a proprietary AAV Curator platform.

Anemocyte S.r.l.

Italy

Anemocyte is an Italian biotech manufacturing organization (self-described as a BMO) specializing in plasmid DNA, mRNA, and viral vector development and manufacturing for the cell and gene therapy sector. They provide GMP-grade contract manufacturing services for advanced therapies.

Batavia Biosciences

Netherlands

Batavia Biosciences is a Netherlands-based CDMO dedicated to viral vector and vaccine development. They provide process development, GMP manufacturing through their Batavia Biomanufacturing division, and offer proprietary technologies including HIP-Vax, SCOUT, SATIRN, STEP, and SIDUS platforms. They support clients from bench to bedside in viral vectors, viral vaccines, recombinant proteins, and oncolytic viruses.

BioCina

Australia

BioCina is a global end-to-end biologics CDMO and the only biologics CDMO in Australia approved by the US FDA. Following the merger with NovaCina, the company provides comprehensive biologics CDMO services spanning cell line development, process development, analytical development, GMP manufacturing of biologics drug substance and drug product, and mRNA manufacturing. Operates facilities in Adelaide, Australia with GMP manufacturing capacity up to 1,000L bioreactors.

Biologics Manufacturing Centre (BMC) Inc.

Canada

Biologics Manufacturing Centre (BMC) Inc. is a Canadian end-to-end GMP biomanufacturing facility with a public good mandate, established to secure domestic biologics supply. Licensed by Health Canada (DEL 3-002766-A and 3-002818-A) to manufacture and test biological products and vaccines. The facility is BSL-2 accredited and supports orphan drug development for rare and genetic diseases. Subsidiary of the National Research Council Canada.

CannaPiece Corp

Canada

CannaPiece Corp is a Canadian contract manufacturer providing services to Licensed Producers in the cannabis market. Based in Pickering, Ontario, the company offers packaging, capsule fabrication, and product development services under GMP conditions, holding a Health Canada Drug Establishment License for processing and sales.

CATUG (CATUG Biotech)

China

CATUG Biotech (also known as CATUG Biotechnology) is a Chinese CRDMO specializing in plasmid DNA, mRNA, and delivery system manufacturing for cell and gene therapy and nucleic acid therapeutics. The company operates a one-stop service platform covering plasmid CDMO, mRNA CDMO, and delivery system CDMO services, including GMP manufacturing, sterile filling, and analytical/quality study services. CATUG provides end-to-end support from research customization through CMC to technology transfer and GMP production.

celares GmbH

Germany

celares GmbH is a German CDMO focused on the development and manufacturing of polymer-based drug delivery excipients and bioconjugate drugs. The company specializes in PEGylation technology and conjugate vaccine development, with collaborations including EMD Millipore and NOF Corporation. celares has been acquired by Biosynth, which expanded its capabilities into conjugate vaccines and bioconjugation services.

Cellab CDMO

Andorra

Cellab CDMO is a Contract Development and Manufacturing Organization based in Andorra, specializing in Advanced Therapy Medicinal Products (ATMPs) including cell and gene therapies. The company provides end-to-end services from concept and early-stage development through clinical programs and commercialization under GMP. Cellab supports therapy developers with an agile approach to accelerate ATMP development from bench to bedside.

CellEasy

France

Cell-Easy (CellEasy) is a French CDMO specializing in GMP cell therapy manufacturing, supporting academic laboratories, biotechs, and pharma companies through development and clinical programs. The company has manufactured over 1,000 clinical doses in its GMP facility and has handled 15+ cell types including T cells, NK cells, T regs, MSCs, iPSCs, and immortalized cell lines across 50+ development programs. Cell-Easy follows ICH Q2(R1), European Pharmacopoeia, EMA/MHRA, and US Pharmacopoeia standards.

Cellex Cell Professionals GmbH

Germany

Cellex Cell Professionals GmbH is a European CDMO with over 10 years of experience in autologous and allogeneic cell therapy, partnering with top pharma companies, biotech firms, and academic institutions for clinical trials and post-approval commercial production. Three approved CAR-T therapies are produced in Cellex's GMP-compliant facilities. The company provides full-service capabilities including cell collection, manufacturing of ATMPs/CGT products, process development and validation, supply chain management, GMP audits of medical facilities, and consulting from preclinical development to commercialization.

CELLforCURE by SEQENS

France

CELLforCURE by SEQENS is a leading EMA-authorized CDMO dedicated to the development and commercial manufacturing of cell and gene therapies (ATMPs). Located near Paris, the company operates a 10,000 m2 site with 3,000 m2 of GMP area featuring 7 independent GMP manufacturing lines, 48 cleanrooms, and an 800 m2 dedicated QC lab. With over 15 years of track record, CELLforCURE has completed 25+ tech transfers, manufactured 600+ autologous CAR-T commercial doses and 10,000+ allogeneic CAR-T clinical vials.