Biologics Drug Substance CDMOs

Cellistic

Belgium

Cellistic is a Belgium-based CDMO specializing in iPSC-based cell therapy manufacturing, positioned as a global leader in allogeneic iPSC-derived cell therapy production. The company offers full-spectrum manufacturing services including cell line development, process development, GMP manufacturing platforms, ready-to-use iPSC lines, and proprietary gene-editing capabilities. Cellistic operates Europe's first facility dedicated exclusively to iPSC-based cell therapy development and manufacturing in Mont-Saint-Guibert, Belgium.

CellReady

United States

CellReady is the world's first and only G-Rex centric contract development and manufacturing organization (CDMO), specializing in G-Rex based cell and gene-modified cell therapy development and manufacturing. The company is part of the ScaleReady joint venture (with Bio-Techne and Wilson Wolf) and focuses on cancer cell therapies. CellReady is FDA-registered for manufacturing and acquired cell manufacturing assets from Marker Therapeutics for approximately $19 million.

Celonic

Germany

Celonic is a Swiss-based 'Pure Play' biologics CDMO offering end-to-end drug substance development and manufacturing solutions for monoclonal antibodies, bispecifics, and other complex molecules. The company is a pioneer in next-generation bioprocessing technologies including process intensification and full perfusion. Celonic operates facilities in Basel, Switzerland and Heidelberg, Germany, and has a strategic alliance with CARBOGEN AMCIS for integrated ADC development and manufacturing.

Cenexi

Belgium

Cenexi is a Belgian/French CDMO specializing in sterile products, biological and injectable pharmaceutical manufacturing. The company operates four manufacturing sites in Europe, including sites in Fontenay-sous-Bois and Herouville-Saint-Clair (France), Osny (France, for highly active solid pharmaceutical forms), and Belgium. Cenexi offers services from development to commercial production for pre-filled syringes, vials, lyophilized products, tablets, capsules, and syrups, with FDA-registered manufacturing operations.

Center for Breakthrough Medicines (CBM)

United States

Center for Breakthrough Medicines (CBM) is a cell and gene therapy CDMO based in King of Prussia, Pennsylvania, operating at The Discovery Labs campus. CBM offers comprehensive services including plasmid manufacturing (Precision Plasmids), viral vector manufacturing (Genesis Vector Manufacturing Solutions), cell therapy manufacturing, and analytical testing (Analytical Accelerator for AAV testing). SK Pharmteco acquired controlling interest in CBM, and the company has capacity to manufacture therapies for 10,000+ patients.

Cerbios‑Pharma SA

Switzerland

Cerbios-Pharma SA is a privately held Swiss CDMO based in Barbengo-Lugano with over 40 years in the pharmaceutical industry, now part of the HAS Group. The company specializes in the development and manufacture of chemical and biotechnological APIs, with particular expertise in HPAPIs (high-potency APIs), ADC payloads and conjugation, and recombinant proteins and antibodies. Cerbios offers both chemical synthesis and biological manufacturing capabilities, including living microorganism-based products.

ChemPartner

China

ChemPartner is a science-based, technology-driven global CRO and CDMO with over 20 years of experience and 2,000+ scientists. The company provides end-to-end drug discovery through IND services for small molecules and biologics, including antibody discovery, ADC development, and cGMP biologics manufacturing. ChemPartner has expanded its biologics CDMO capabilities with a 67,000 sqm facility in Qidong, China and a new R&D center in Boston.

Chempro Pharma

India

Chempro Pharma Pvt. Ltd. is an Indian CDMO and exporter of APIs, intermediates, KSM, impurities, pellets, and finished dosage forms (FDF). The company operates WHO/EU GMP-approved facilities and is ISO 9001 certified, with manufacturing sites in Vapi, Gujarat and Maharashtra. It provides contract manufacturing services for both APIs and finished formulations.

Cipla

China

Cipla is a major Indian multinational pharmaceutical company that manufactures and markets its own branded generic medicines globally. While Cipla has formed joint ventures with CDMOs like Kemwell Biopharma for biosimilar development, the company itself is a pharmaceutical manufacturer selling its own products, not a contract manufacturer for others.

Cognate BioServices

United States

Cognate BioServices was a premier commercial-ready global CDMO specializing in cell and gene therapy manufacturing, acquired by Charles River Laboratories in 2021 for approximately $875 million. The company, along with its gene therapy division Cobra Biologics, provided cell therapy manufacturing, plasmid DNA production, and viral vector capabilities across US and European facilities. It is now integrated into Charles River's cell and gene therapy CDMO solutions.

CoJourney Inc

China

CoJourney Inc is a CDMO partner specializing in cGMP manufacturing for gene therapies, featuring its proprietary Zero Chrom plasmid manufacturing platform that eliminates chromatography for higher purity and lower cost. The company provides plasmid DNA, viral vector (AAV, lentivirus, adenovirus), sgRNA GMP manufacturing, and exosome manufacturing services, having served over 100 customers and delivered more than 400 batches with a proven IND approval track record with FDA and CDE.

Creative Biolabs

United States

Creative Biolabs is a US-based ISO 9001:2015 certified CDMO providing comprehensive biotechnology and pharmaceutical services including antibody discovery, viral vector CDMO solutions, CAR-T cell therapy manufacturing, and custom bio-manufacturing. The company offers end-to-end services from discovery through cGMP production for biologics including AAV, lentivirus, adenovirus, and HSV vectors.

Dragon Sail Pharmaceutical

China

Dragon Sail Pharmaceutical Co., Ltd. is a Chinese CDMO founded in 2016, focusing on antibody drug CDMO/CMO services from sequence to IND through commercial production. The company built China's first cross-free antibody plant in the Shanghai Lin-gang Special Area with a total investment of nearly RMB 700 million and a maximum production scale of 12,000L.

EirGenix

Taiwan

EirGenix is a Taiwan-based biopharmaceutical CDMO specializing in cell line development, process development, and commercial-scale production of biologics including biosimilars. The company operates facilities in Xizhi and Zhubei, Taiwan, with the Zhubei plant dedicated to late-stage development and commercial production of biological products. EirGenix provides comprehensive services from DNA replication through stable cell line generation to clinical and commercial manufacturing.

ENCell Co., Ltd.

South Korea

ENCell Co., Ltd. is a South Korean biotechnology company and CDMO specializing in cell and gene therapy, founded in 2018 as a spin-off from Samsung Medical Center. The company operates three separate GMP facilities and provides end-to-end pharmaceutical development services from R&D to regulatory approval, including drug substance/product manufacturing and contract quality testing.

Enzene Biosciences Limited

India

Enzene Biosciences is an Indian CDMO and subsidiary of Alkem Laboratories, specializing in biologics and biosimilar development and manufacturing. The company's patented EnzeneX continuous bioprocess manufacturing platform significantly reduces the cost of producing complex biologics and monoclonal antibodies, with facilities in Pune, India and an expanding site in Hopewell, New Jersey, USA.

FinVector

Finland

FinVector is a Finnish cGMP manufacturer of viral-based gene therapy products with over 30 years of experience in drug discovery science and manufacturing. Its new 25,000 square meter Finport facility in Kuopio, opened in partnership with Ferring Pharmaceuticals, represents one of the world's largest viral vector manufacturing capacities using the iCELLis platform from Pall Corporation.

Fisher BioServices (Thermo Fisher)

Netherlands

Fisher BioServices is part of Thermo Fisher Scientific's Patheon pharma services division, one of the world's largest CDMOs offering end-to-end 360-degree CDMO and CRO solutions. The Patheon platform covers drug substance and drug product manufacturing for small molecules, large molecules, and advanced therapies, along with clinical supply and commercialization services.

Forge Biologics (Ajinomoto Group)

United States

Forge Biologics, acquired by Ajinomoto Group in 2023 for $554-620 million, is a gene therapy CDMO specializing in high-purity adeno-associated virus (AAV) vector and plasmid manufacturing. The company operates a 200,000 sq ft Hearth facility in Columbus, Ohio with 20 cGMP suites and 20,000L bioreactor capacity, providing end-to-end services from preclinical process development through commercial manufacturing.

Fortis Life Sciences

United States

Fortis Life Sciences is a CDMO partner to diagnostics and life science companies, offering an integrated portfolio of reagents, components, and service solutions. The company provides antibody development and manufacturing, conjugation services, lyophilization, cell and gene therapy support, and diagnostic assay CDMO services.

Fraunhofer Institute for Cell Therapy and Immunology (IZI)

Germany

The Fraunhofer Institute for Cell Therapy and Immunology (IZI) in Leipzig is a contract research and GMP manufacturing institute specializing in cell and gene therapy, vaccines, and biologics. The institute provides GMP-compliant manufacturing of clinical trial materials (ATMPs and biologicals), process development for pharmaceutical manufacturing, and regulatory support for manufacturing authorizations and approvals.

GC Cell

South Korea

GC Cell is a South Korean cell therapy pioneer and CDMO, an affiliate of GC Biopharma. The company has its own commercialized cell therapy product (Immuncell-LC) and offers comprehensive CDMO capabilities spanning R&D, GMP manufacturing, logistics, and advanced therapies. GC Cell has expanded its CDMO footprint to the US through the acquisition of Made Scientific and a partnership with BioCentriq for cell therapy manufacturing.

GENEFAB

United States

GeneFab is a US-based contract research, development, and manufacturing organization (CRDMO) focused on cell and gene therapies, operating from Alameda, California. The company acquired Senti Bio's production facility and specializes in lentiviral, retroviral, and adeno-associated viral vector manufacturing. GeneFab provides end-to-end services from genetic design and process development through cGMP clinical and commercial manufacturing.

Genezen (USA)

United States

Genezen (USA) is a leading cell and gene therapy CDMO founded in 2014, specializing in lentiviral, retroviral, and adeno-associated viral (AAV) vector manufacturing. The company operates a 60,000 sq ft cGMP facility in Fishers, Indiana and an 86,000 sq ft licensed facility in Lexington, Massachusetts. Genezen provides end-to-end services from preclinical through commercial manufacturing, with FDA registration and established manufacturing partnerships.

GenScript ProBio

China

GenScript ProBio is a leading biologics CDMO and subsidiary of GenScript Biotech Corporation, providing end-to-end services from discovery to commercialization. The company has raised $224 million in C-round funding, operates GMP plasmid and viral vector manufacturing facilities in Hopewell, New Jersey and Nanjing, China, and has established a manufacturing facility in Singapore. GenScript ProBio specializes in antibody discovery, cell and gene therapy manufacturing, and biologics development.

Helix Biotech, Inc.

United States

Helix Biotech, Inc. is a U.S.-based CDMO specializing in GMP formulation and RNA manufacturing, including DNA, RNA, and LNP (lipid nanoparticle) formulations. The company offers end-to-end services from RNA construct design through its StrandSolve platform to GMP manufacturing via its NOVA IJM nanoparticle formulation platform.

Helvetic BioPharma SA

Switzerland

Helvetic BioPharma SA is a Swiss biopharmaceutical company based in Mezzovico, Ticino, specialized in the manufacturing of biological high-value products and active compounds. The company offers CMO bioprocessing services including mammalian cell culture and microbial fermentation. Its product portfolio includes recombinant proteins, hormones, and peptides, with PEGylation capabilities for long-acting molecules.

Hongene Biotech

China

Hongene Biotech is a China-based CDMO specializing in oligonucleotide and mRNA manufacturing services. The company provides custom DNA/RNA synthesis and large-scale oligonucleotide production for pharmaceutical and biotech customers globally.

HTL Biotechnology

France

HTL Biotechnology is a French biotech company and world leader in the development and responsible biomanufacturing of pharmaceutical-grade biopolymers, primarily hyaluronic acid (sodium hyaluronate) and polynucleotides (PDRN/PN). The company produces these as raw materials/APIs for pharmaceutical, medical device, and cosmetic applications via fermentation technology.

Icosagen

Estonia

Icosagen is a private, science-driven biologics CRDMO headquartered in Estonia, combining CRO and CDMO capabilities under one roof. With 25 years of expertise, the company provides integrated services spanning antibody discovery, protein production, cell line development, ADC conjugation, process development, and GMP manufacturing for mammalian protein drug candidates.

Kemwell Biopharma Private Limited

India

Kemwell Biopharma is one of India's largest biologics CDMOs, providing integrated drug substance and drug product development and manufacturing services from a single site in Bangalore. Established with technological support from a leading German biopharmaceutical company, Kemwell serves global pharma and biotech organizations with capabilities spanning monoclonal antibodies, complex fusion proteins, recombinant proteins, and bispecific antibodies. The company has received U.S. FDA approval for commercial drug product manufacturing and operates hybrid biomanufacturing with both stainless steel and single-use bioreactor systems.

Kincell Bio

United States

Kincell Bio is a specialized cell therapy CDMO based in the United States, dedicated exclusively to advancing autologous and allogeneic cell therapies from early clinical supply through pivotal and commercial launch. They provide process development, analytical development, and cGMP manufacturing services. The company operates manufacturing facilities in Research Triangle Park, North Carolina (32,800 sq ft acquired in 2024) and Gainesville, Florida. They have a strategic collaboration with Duke University School for cell and gene therapy innovation, and a partnership with RegCell to advance Treg cell therapies for autoimmune diseases.

List Biological Laboratories Inc

United States

List Biological Laboratories Inc (List Labs) is a US-based CDMO with over 45 years of experience specializing in microbial-derived biologics and live biotherapeutic products (LBPs). The company provides cGMP manufacturing services for bacterial fermentation, harvest, purification, lyophilization, and encapsulation of therapeutic and vaccine products including polysaccharides, toxins, toxoids, and recombinant proteins. List Labs also manufactures nearly 100 research reagents.

medac GmbH (medac CDMO)

Germany

medac GmbH operates a dedicated CDMO division (medac CDMO) offering end-to-end sterile injectable manufacturing services from clinical supply through large-scale commercial production. Based in Germany with facilities in Wedel and Dessau (Germany) and Brno (Czech Republic), medac specializes in small molecules, biologics (mAbs, proteins, peptides, oligonucleotides), and ADCs. They handle aseptic filling, terminal sterilization, lyophilization, and high-potent API processing down to OEL = 10 ng/m3. Manufacturing scales range from 1-50 L (small) to 50-1,500 L (large) with campaigns up to 11,000 L. They partner with Cerbios under the PROVEO brand for integrated ADC services. Over 40 years of regulatory expertise with approvals from multiple international health authorities.

Microbiosci (Creative Biogene)

United States

Microbiosci (Creative Biogene) is a US-based biotech CDMO specializing in microbial fermentation-based production of commercial biological substances. The company provides GMP manufacturing services for recombinant proteins, recombinant pharmaceutical proteins, monoclonal antibodies, nucleic acid drugs, APIs, peptides, microbial metabolites, and enzymes. Their integrated platform includes strain development, fermentation process development, upstream/downstream processing, and fill-finish services.

Minaris Advanced Therapies

United States

Minaris Advanced Therapies (formerly Hitachi Chemical Advanced Therapeutics Solutions) is a global cell and gene therapy CDMO with 25+ years of autologous expertise. The company provides end-to-end GMP manufacturing and advanced testing services for gene-edited autologous (CAR-T, TCR-T), allogeneic (NK, HSC, iPSC), non-edited cell therapies, and vaccines. FDA-registered manufacturing site with FEI number.

Northway Biotech

Lithuania

Northway Biotech is a global end-to-end biologics CDMO specializing in protein-based biologics and gene therapies. The company operates state-of-the-art facilities in Vilnius, Lithuania (EU) and Waltham, Massachusetts (US), with 20+ years of technical expertise. Northway offers cell line development, process development, analytical development, and cGMP manufacturing of drug substances and drug products using both mammalian cell culture and microbial fermentation technologies.

NorthX Biologics

Sweden

NorthX Biologics is a Swedish CDMO specializing in advanced biologics and ATMPs (Advanced Therapy Medicinal Products). The company offers end-to-end services from process development to GMP manufacturing for recombinant proteins, viral vectors, plasmid DNA, cell therapy, extracellular vesicles, and mRNA. Recognized by the Swedish Government as an international competence center and innovation hub in 2021, NorthX has 30+ years of GMP manufacturing experience.

Numaferm GmbH

Germany

Numaferm GmbH is a German biotech company specializing in the biochemical production of peptides and proteins using its proprietary Numaswitch and Numatech expression platforms. The company offers contract development and manufacturing services from discovery through commercial/GMP supply, partnering with established CMOs for large-scale production. Numaferm has completed over 200 successful peptide projects and is ISO 9001:2015 certified.

OBiO Tech (OBiO Technology)

China

OBiO Technology (Shanghai) Corp., Ltd (688238.SH) is a China-based biotechnology company and CRO/CDMO group focusing on cell and gene therapy. The company provides end-to-end offerings including process development, analytical method development, IND-enabling CMC, and clinical and commercial contract manufacturing of viral vectors, oncolytic viruses, and cell therapy products. OBiO operates a 10,000-square-meter GMP campus (Intelli-M PINE Site) with 29 GMP production lines.

OmniaBio Inc

Canada

OmniaBio Inc is Canada's largest cell and gene therapy CDMO, established by CCRM in 2022. The company provides end-to-end contract development and manufacturing services for autologous and allogeneic cell therapies, lentiviral vectors, and immunotherapies. Its Hamilton, Ontario facility integrates AI, automation, and robotics to enhance manufacturing efficiency and reduce costs.

OneSource Specialty Pharma Limited

India

OneSource Specialty Pharma Limited (formerly Stelis Biopharma Limited) is India's first specialty pharma pure-play CDMO, offering multimodal end-to-end capabilities across drug-device combinations, complex sterile injectables, biologics, and soft gelatin capsules. The company operates five state-of-the-art facilities in Bengaluru with 35 approved ANDAs and 19 commercialized drug products in the US market.

Oxford Biomedica (OXB)

United Kingdom

Oxford Biomedica (OXB) is a global, quality- and innovation-led CDMO specializing in viral vector development and manufacturing for cell and gene therapy. With 25+ years of experience, OXB is the first and currently only FDA-approved CDMO for commercial production of lentiviral vectors for CAR-T therapy. The company operates GMP suites across three countries with extensive end-to-end capabilities in lentivirus, AAV, and adenovirus vectors.

Pharmicell Chemical

South Korea

Pharmicell Co., Ltd. is a South Korean biopharmaceutical company operating both chemical (API) and biologics (stem cell therapy) divisions, with CDMO services. The Chemical Business Unit in Ulsan (Onsan) manufactures oligonucleosides, pharmaceutical PEGs, and industrial advanced materials. The Bio division developed the world's first approved stem cell therapy (Hearticellgram AMI for cardiac repair) and provides CDMO services for advanced cell therapies with GMP facilities including Grade B/C clean rooms, virus testing labs, and microorganism testing labs. The company holds ISO 9001, ISO 14001 certifications and reported record revenue of 114 billion KRW in 2025. Pharmicell is expanding CDMO operations for regenerative medicine with capability to handle 7 cell types.

ProteoGenix SAS

France

ProteoGenix SAS is a French antibody production company founded in 2003, providing integrated solutions for custom antibody development, recombinant protein expression, and bioproduction services. The company offers therapeutic antibody discovery, humanization using proprietary AI, ADC development, bispecific antibody development, CAR-T platforms, and custom cell line development across 6 manufacturing sites. ProteoGenix serves the therapeutics, diagnostics, research, and animal health markets.

Protheragen-ING

China

Protheragen-ING is a China-based comprehensive integrated service provider specializing in drug development and biotechnology solutions. The company offers both small molecule and large molecule (antibody, ADC, protein therapy) development and manufacturing services, with an extensive pipeline of available drug development projects spanning antibody therapies, oncolytic virotherapy, cell therapy (CAR-T), and small molecules. Protheragen is FDA-registered for API manufacture and operates project incubation and equity investment services for drug candidates.

RD‑Biotech

France

RD-Biotech is a French biotechnology CRO/CDMO founded in 2002, offering custom solutions in molecular biology, immunology, and cellular engineering for R&D, preclinical, and clinical programs. They specialize in plasmid DNA production (including GMP grade), monoclonal antibodies, recombinant antibodies, recombinant proteins, and cell culture/banking. They have a strategic partnership with ABL for cell and gene therapy GMP manufacturing.

Recipharm AB

Sweden

Rechon Life Science AB is a subsidiary/entity within the Recipharm group, the global CDMO headquartered in Stockholm, Sweden. This entry represents the same Recipharm organization (same website: recipharm.com) with its extensive global manufacturing footprint of 15+ FDA-registered FEI numbers and 52 FDA inspections. The Perplexity research confirms Recipharm's specialization in oral solid dose, inhalation, sterile manufacturing, and HPAPI capabilities. Rechon may represent a specific Recipharm site or legacy entity. Duplicate of Recipharm AB entry -- capabilities are identical.