Immunology CDMOs

Theragent Inc

United States

US-based comprehensive CDMO focused on advancing next-generation cell- and tissue-based therapies, from R&D to cGMP manufacturing. Located in Arcadia, California. Has partnerships with CellVax Therapeutics (first manufacturing collaboration, Phase 2 trial for FK-PC101), Pluristyx (iPSC-derived therapies), and Insight68 (Pharma 4.0 AI software). Works with iPSC, NK cells, T cells, and CAR-T for allogeneic and autologous therapies. Expanding leadership team with experienced biopharma executives.

Cenra Pharma (formerly CCPC, China Chemical & Pharmaceutical Co.) is a Taiwanese pharmaceutical company established in 1952 that develops and manufactures APIs and generic drugs, also providing CMO/CDMO services. The company has FDA and PMDA facility approvals, PIC/S GMP compliance, and offers services from API selection through formulation development and commercial manufacturing. Cenra specializes in high-potency drugs including immunosuppressants and oncology drugs, with dedicated production lines for penicillins, cephalosporins, carbapenems, and immunosuppressants.

Laurus Bio

India

Laurus Bio is a subsidiary of Laurus Labs, an integrated research-driven biomanufacturing organization based in Bengaluru, India, with deep expertise in precision fermentation and recombinant technology. They engineer microbes as cell-factories to manufacture animal-free recombinant proteins and growth factors for biopharma, food, health, nutrition, and personal care markets. Offers precision fermentation CDMO and scale-up services, from clone development to large-scale manufacturing. Acquired as Richcore Lifesciences in 2020 and rebranded as Laurus Bio.

Lupin Limited (Lupin Manufacturing Solutions)

Brazil

Lupin Manufacturing Solutions (LMS) is the CDMO arm of Lupin Limited, one of India's largest pharmaceutical companies. LMS offers integrated CDMO services spanning API manufacturing, formulation development, and finished dosage form production. They operate 16 FDA-registered facilities with 512 FDA-approved products. They have recently expanded into oncology with a dedicated block at Vizag, India, and formed a strategic alliance with PolyPeptide for peptide supply chain scaling. Their extensive regulatory track record includes FDA, WHO, and multiple international approvals.

Pace Life Sciences is a division of Pace Analytical Services LLC, operating as a full-service CDMO/CRO network across the United States. The company supports drug development across the entire lifecycle from preclinical research through commercialization, specializing in small molecules, biologics (proteins, peptides, monoclonal antibodies, ADCs), nucleic acids (oligonucleotides, mRNA, plasmid DNA), and gene therapies. Recognized by PharmaSource as a Top CDMO in the United States. Operates 9+ strategically located sites including a sterile fill-finish Center of Excellence in Salem, NH.

Parexel International (MA) Corporation

Argentina

Parexel is a global contract research organization (CRO) providing clinical trial management, regulatory consulting, and biopharmaceutical development services. With over 24,000 professionals and 50+ clinical sites across five continents, the company offers Phase I-IV clinical trial services, CMC regulatory strategy, and real-world evidence generation. Parexel is primarily a CRO, not a drug manufacturer.

Reliance Life Sciences (RLS), part of Reliance Industries, is a premier Indian biotechnology company providing contract manufacturing and development services across pharmaceuticals and biosimilars. They have FDA-registered manufacturing facilities with 7 FDA-approved products (injectables, powders, tablets). Their capabilities span API manufacturing, formulation development, biologics/biosimilar manufacturing, and cell and gene therapy R&D. They are a vertically integrated biotech company with 1,000-5,000 employees, offering CDMO services alongside their own product portfolio.

Symbiotec Pharmalab is a leading Indian manufacturer of corticosteroid and steroidal-hormone APIs with a global leadership position. With over 30 years of experience, the company has evolved from lab-scale manufacturing to industrial-scale production, operating two FDA-approved facilities (Rau and Pithampur, Indore). The company offers integrated CDMO solutions across organic chemistry, biotechnology/fermentation, and complex injectable platforms. It holds a 50%+ global market share in key steroid API molecules and serves 200+ customers in 40+ countries.

Division of Terumo Corporation (TSE:4543), a global healthcare technology leader since 1921 with 30,000+ employees. Provides sterile injectable contract development and manufacturing (CDMO) services from combination device design and formulation development to commercial manufacturing. Offers a portfolio of injection, infusion, and primary packaging solutions including PLAJEX polymer pre-fillable syringes, Immucise intradermal injection systems, hypodermic needles, and Surflo winged infusion sets. Recently expanded CDMO services outside Japan for global market and is doubling capacity.

FUJIFILM Biotechnologies (formerly FUJIFILM Diosynth Biotechnologies) is a global biologics CDMO operating 10 facilities across the US, UK, Denmark, and Japan with over 4,800 employees. The company provides end-to-end cGMP manufacturing services for biologics, advanced therapies, and vaccines, from preclinical through commercialization, with $8.6 billion invested in recent years and 20+ commercial licenses.

Gesellschaft fur Micronisierung mbH (GfM) is a German-based, family-owned contract manufacturer with over 35 years of experience, specializing in micronization, milling, and particle size reduction services for the pharmaceutical industry. The company has FDA registration and has received FDA inspections. GfM provides cGMP contract manufacturing services for API intermediates and particle size engineering.

Goodwin Biotechnology (GBI) is a full-service biopharmaceutical CDMO based in Florida, specializing in biologics development and manufacturing. Named Manufacturer of the Year by BioFlorida, GBI offers its Single-Source Solution for monoclonal antibodies, ADCs, recombinant proteins, and other complex biologics from cell line development through cGMP commercial manufacturing. The company provides mammalian cell culture manufacturing using CHO and other expression systems.

I Peace Inc. is a Palo Alto, California-based biotech CDMO specializing in cGMP manufacturing of iPSC (induced pluripotent stem cells) and iPSC-derived cell products for cell and gene therapy development. The company provides custom GMP cell manufacturing, process development, cell banking (MCB/WCB), gene editing, differentiation services, and regulatory support compliant with FDA, PMDA, and EudraLex standards. I Peace has manufactured 100+ GMP iPS cell lines and tripled its CDMO facility capacity.

JSR Life Sciences (KBI Biopharma / Selexis)

Switzerland

JSR Life Sciences is the parent organization of KBI Biopharma (CDMO) and Crown Bioscience (CRO), plus Selexis (cell line development). KBI Biopharma is a biologics CDMO providing mammalian and microbial expression, process development, analytical development, and clinical through commercial GMP manufacturing. Crown Bioscience is a separate CRO arm focused on preclinical oncology. This entity spans CDMO and CRO, but the primary CDMO identity is through KBI Biopharma. FDA registered with 4 FEI numbers and 5 inspections (4 NAI, 1 VAI).

Jubilant Biosys Limited

India

Jubilant Biosys is a CRDMO (Contract Research, Development and Manufacturing Organization) under Jubilant Pharmova. Over 20 years experience, 2,400+ employees, five sites across India and Europe. Offers integrated drug discovery (IDD), chemistry services, biology services, and CDMO services including process R&D, analytical development, technology transfer, GLP/non-GMP/GMP manufacturing. Recently expanding into biologics and ADC discovery at European site. FDA registered with 3 FEI numbers, 14 inspections including 4 OAI -- regulatory risk flag. Note: Website claims biologics/ADC capability but this is at discovery stage only, not GMP manufacturing.

KareBay Biochem

China

KareBay Biochem (Monmouth Junction, NJ) is a custom synthesis and contract manufacturing company offering organic synthesis, peptide synthesis (including cGMP peptide synthesis), antibody production, protein expression, bioconjugation, oligonucleotide synthesis, RNA synthesis, polymer synthesis, and immunoassay services. Also sells catalog products (small molecule inhibitors, bioactive compounds, peptides, antibodies, amino acids, fluorescent dyes). Products are for research, laboratory and further evaluation purposes. cGMP peptide and organic synthesis services are explicitly offered.

KBI Biopharma

Switzerland

KBI Biopharma is a global biologics CDMO (part of JSR Life Sciences) providing mammalian and microbial-based biopharmaceutical development and manufacturing services. Offers cell line development (SUREtechnology Platform powered by Selexis for CHO, PUREplatform for E. coli), process development, analytical development, formulation development, characterization, clinical and commercial GMP manufacturing. FDA registered (FEI 3004638264) with ANALYSIS, API MANUFACTURE, and MANUFACTURE operations. Positioned as a 'next-generation CDMO' with standalone services portal for analytical testing.

Laboratorios Farmaceuticos ROVI S.A. is a major Spanish CDMO and pharmaceutical company, one of the leading European contract manufacturers for high-value-added injectable products. Their CDMO division (ROIS) operates three industrial complexes: two for injectables (Madrid and San Sebastian de los Reyes) and one for oral solid forms and packaging (Alcala de Henares). They also have two facilities in Granada for their own products (bemiparin and enoxaparin). ROVI's Madrid injectables plant is approved by EMA, FDA, and regulators in Korea, Brazil, and Gulf States, with ISO 9001, ISO 14001, and OSHAS certifications. They recently acquired a Bristol-Myers Squibb injectable drug product manufacturing site in Phoenix, Arizona for $250 million, expanding their capacity. ROVI provides end-to-end services from development to final product release, including clinical trials, stability studies, and analytical services. They have collaborated with Roche for manufacturing new medicines in development.

Lundbeck Pharmaceuticals Italy SpA

Italy

Lundbeck Pharmaceuticals Italy SpA is an Italian API manufacturer with 80 years of industry experience, producing Active Pharmaceutical Ingredients including Metoclopramide Hydrochloride. Part of the Lundbeck Group (Denmark), they operate multiple FDA-registered facilities with extensive inspection history. While primarily a proprietary pharma manufacturer (Lundbeck is known for CNS drugs), their Italian operation manufactures APIs and has FDA-approved products across injectable and oral dosage forms. They also have clinical trial activity in CNS/Neurology and Immunology.

SCI Pharmtech Inc. is a Taiwan-based API manufacturer originally founded by Switzerland-based Siegfried Ltd. in 1987, now publicly listed on the Taiwan Stock Exchange. The company specializes in APIs, advanced intermediates, and custom products with US FDA and EDQM inspected, ISO-certified facilities. SCI Pharmtech focuses on rapid development and cost-effective production.

Greek advanced biotechnology company focused on cell and gene therapy (CDMO activity). Subsidiary/partner of Orgenesis Inc. Designated as a priority investment in Greece in collaboration with Orgenesis. Aims to make advanced therapies accessible and affordable. Recognized as a top precision medicine solution company in Europe. Note: website has SSL certificate error and is inaccessible, so information is primarily from search results and SEC filings indicating CDMO activity for cell/tissue-based therapies.

Alfasigma (Morpho CDMO)

Italy

Alfasigma operates a CDMO division (Morpho CDMO) based in Italy. No website content was available for detailed capability extraction, but the company is listed with a dedicated CDMO URL suggesting contract development and manufacturing services.

Corning Incorporated (Life Sciences & Pharmaceutical Technologies)

India

Corning Incorporated's Pharmaceutical Technologies division manufactures advanced glass packaging solutions for the pharmaceutical industry, most notably Valor Glass vials and containers designed for drug storage and delivery. The company is a materials science and glass technology company, not a drug manufacturer or CDMO.

CSL (incl. CSL Behring)

Australia

CSL is a global biotechnology company headquartered in Melbourne, Australia, operating through CSL Behring, CSL Seqirus, and CSL Vifor. The company specializes in plasma-derived biotherapies for rare and serious diseases including bleeding disorders and immunodeficiencies, vaccines, and iron deficiency treatments, but operates as an integrated developer/manufacturer for its own products rather than as a CDMO offering contract services to external clients.

EMA Pharmaceuticals (Ema Pharma)

France

EMA Pharmaceuticals (Ema Pharma) is a French manufacturer of overseals (crimping capsules) for injectable pharmaceutical applications. The company specializes in sealing solutions for vials used in pharmaceutical injectable products, manufactured in a GMP-compliant facility. Note: The FDA regulatory data (90 approved products, 184 recalls) appears to be associated with a different entity sharing the FEI registrations, not the French crimp cap manufacturer.

SteriMax Inc.

Canada

SteriMax Inc. is a family-owned Canadian specialty pharmaceutical company based in Oakville, Ontario. They develop, source, manufacture, market, and distribute essential hospital and retail pharmacy products to the Canadian healthcare market. Their portfolio includes generic and branded products across sterile injectables, oral solids, and other essential products. SteriMax has a Health Canada-approved QC lab and their products are manufactured in Health Canada, FDA, or EMEA approved facilities. While they have some internal pharmaceutical manufacturing capabilities (their website mentions production and manufacturing), their primary model appears to be sourcing, marketing, and distributing pharmaceutical products in Canada rather than offering contract manufacturing services to third parties. They are not positioned as a CDMO/CMO.

Just - Evotec Biologics (wholly owned by Evotec) is a biologics CDMO specializing in monoclonal antibodies, next-generation biologics, and biosimilar products. Differentiated by proprietary integrated end-to-end continuous manufacturing platform (J.POD) which uses perfusion cell culture with continuous purification, achieving higher output in smaller footprint than traditional batch manufacturing. Two manufacturing sites in Seattle and Redmond, WA. Offers cell line development, analytical services, process development, and early clinical through commercial cGMP manufacturing. Uses AI/ML technologies in development.

Jiangsu Hengrui Medicine Co., Ltd. is China's largest listed pharmaceutical company, founded in 1970, with over 20,000 employees globally. Hengrui is primarily an innovation-driven pharma company developing and manufacturing its own drugs across oncology, cardiovascular, metabolism, autoimmune, pain, and anti-infection therapeutic areas, with a pipeline of 257 drugs and 24 Class 1 innovative drugs. While it has some CDMO references in search results, Perplexity research confirms it primarily specializes in proprietary drug development and manufacturing rather than contract services.

Sun Pharmaceutical Industries Ltd. (Sun Pharma) is one of the world's largest specialty generic pharmaceutical companies, headquartered in Mumbai, India. While the company has massive manufacturing operations (1,075 FDA-approved products, 25+ FDA-registered FEI numbers), it primarily manufactures and markets its own branded and generic pharmaceutical products rather than providing contract manufacturing services to third parties as a CDMO.