Biologics Drug Substance CDMOs

Piramal Pharma Solutions (PPS) is a global CDMO under Piramal Pharma Limited, offering end-to-end development and manufacturing solutions across the drug lifecycle. Operates through a globally integrated network of 17 development and manufacturing facilities across North America, Europe, and Asia, with distribution in 100+ countries. Services include drug discovery, process/pharmaceutical development, clinical trial supplies, and commercial supply of APIs and finished dosage forms. Specialized in highly potent APIs, antibody-drug conjugations, sterile fill/finish, and peptide products. Multiple CDMO Leadership Award winner.

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.

TOT BIOPHARM is a China-based biopharmaceutical CDMO headquartered in Suzhou Industrial Park, providing end-to-end CDMO services with established technology platforms focused on biologics and ADC manufacturing. The company operates a large-scale GMP-compliant commercial production base with 20,000L monoclonal antibody drug substance capacity, and has achieved PMDA (Japan) accreditation. Listed on HKEX (1875.HK).

TriLink BioTechnologies LLC

United States

TriLink BioTechnologies LLC is a US-based CDMO (part of Maravai LifeSciences) specializing in nucleic acid chemistry and mRNA production. They offer CleanCap capping technology, custom mRNA synthesis and manufacturing (research through GMP clinical and commercial), custom oligonucleotide synthesis, guide RNA (gRNA) for CRISPR, and NTP (nucleotide) manufacturing. Their 118,000 sq ft facility contains multiple specialized GMP manufacturing suites. Over 110 GMP mRNA batches manufactured and 500+ CleanCap mRNA constructs enabled for preclinical/clinical programs.

Vectron Biosolutions

Norway

Vectron Biosolutions AS is a Norwegian CDMO and strain development service provider based in Trondheim, specializing in microbial (E. coli) protein production. They leverage proprietary next-generation expression technologies including the VB Secretion Technology for efficient large-scale protein secretion in E. coli. They offer customized E. coli strain development, expression vector optimization, and bioprocessing services. They partner with CDMOs like Cytovance Biologics to add customized strain development capabilities for complex microbial molecules. Despite having no website content available, multiple search results and press releases confirm their CDMO positioning. The company website (vectronbiosolutions.com) was not accessible at scrape time.

Duplicate entry for VGXI Inc (see companyId 58cac364). Same company -- leading plasmid DNA CDMO in Texas. Same website URL (vgxii.com). Same capabilities, facilities, and services.

Vibalogics is a specialized global CDMO for virotherapy manufacturing, now operating as Recipharm Advanced Bio after acquisition by Recipharm AB. The company offers process and analytical development, GMP manufacturing of viral vectors, oncolytic viruses, and advanced therapies. Capabilities include xRNA therapies, viral vectors (AAV, lentivirus), microbial/live biotherapeutic products, recombinant proteins, plasmid DNA, and lipid nanoparticles. Major $50M expansion of Cuxhaven facility (500L manufacturing line) completed. 118,000 sq ft GMP facility in Massachusetts (US) also completed.

Asahi Kasei Bioprocess America, Inc.

United States

Asahi Kasei Bioprocess America, Inc. (AKBA) is a subsidiary of Asahi Kasei providing advanced filtration and fluid management solutions for the biopharmaceutical industry. They supply bioprocessing equipment and consumables such as filters, single-use bags, and tubing used in biomanufacturing, rather than manufacturing drugs themselves.

Celanese

China

Celanese Corporation is a global leader in chemistry, producing specialty material solutions used across most major industries and consumer applications. In the pharmaceutical space, Celanese supplies medical-grade polymers and excipients for pharmaceutical formulations and medical devices, including its VitalDose drug delivery platform for controlled release. The company is a raw material and excipient supplier to the pharma industry, not a contract drug manufacturer.

CHA Biotech is a South Korean biotechnology company within the CHA Hospital Group, established in 2002 with over 20 years of expertise in stem cell research and cell and gene therapy. The company operates a global CGT CDMO network through its US subsidiary Matica BioLabs, with GMP facilities in Korea (CHA Bundang Medical Center, Pangyo Techno Valley) and the US (Texas). CHA Biotech offers viral vector production (500L capacity for clinical trials) and has secured multiple CDMO contracts for CAR-T and organoid therapies.

Chitose Bio Evolution

Japan

Chitose Bio Evolution Pte. Ltd. is a biotechnology company based in Japan and Singapore focused on zero-carbon emission through photoautotrophic microalgae production. The company works on carbon capture technology and bio-based materials rather than pharmaceutical manufacturing.

Chongqing Sintaho Pharmaceutical Co., Ltd. is a CDMO with 1 FDA-registered factory and 2 R&D centers, specializing in high-potency small molecules and XDC (antibody-drug conjugate linker-payloads). The company provides drug substance CDMO/CRO services with expertise in API and XDC development showcased at major industry events.

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.

Future Fields

Canada

Future Fields is a Canadian CDMO specializing in recombinant protein production using its proprietary EntoEngine platform based on Drosophila melanogaster (fruit flies). The company offers custom protein expression services for difficult-to-express proteins, serving biopharma, agriculture, and food innovation clients. Future Fields operates a 6,000 sq ft production facility (Instar 1.0) and has raised $8 million in Series A funding.

Genezen Labs (India) is the Indian entity of Genezen, a cell and gene therapy CDMO specializing in viral vector manufacturing services. The company provides lentiviral, retroviral, and adeno-associated viral (AAV) vector CDMO services, along with cell therapy manufacturing and plasmid design. Genezen operates a 60,000 sq ft cGMP facility in Fishers, Indiana and an 86,000 sq ft licensed viral vector manufacturing facility in Lexington, Massachusetts.

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.

HydRegen Limited

United Kingdom

HydRegen Limited is a UK-based biotechnology company specializing in biocatalysis and sustainable chemistry for pharmaceutical intermediates. The company develops proprietary enzyme platforms including H2BioCat for asymmetric reductions and Bio2Amine for nitro-to-amine reductions, partnering with companies like Almac Sciences and Ingenza.

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).

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.

LOTTE BIOLOGICS

South Korea

LOTTE BIOLOGICS is a global biologics CDMO headquartered in South Korea, offering end-to-end development and cGMP manufacturing services for biological Drug Substance. Operates the Syracuse Bio Campus (New York, USA) with 40,000L capacity and the Songdo Bio Campus (Incheon, South Korea) planned for 120,000L by 2027. Also operates a $100M ADC manufacturing facility.

Mabion S.A.

Poland

Mabion S.A. is a Polish end-to-end biologics CDMO offering Drug Substance manufacturing, fill/finish, process development, cell line development and banking, and analytical services. Headquartered in central Poland (1.5 hours from Warsaw airport), they position themselves as a European CDMO partner for pharma and biotech companies. Their capabilities span the full biologics lifecycle from gene to vial.

MabPlex International

China

MabPlex International is a China-headquartered CDMO providing comprehensive biomanufacturing services for the global biopharmaceutical and biotechnology industry. They offer innovative CRO and CMO services for biologics, with facilities in China and the USA (MabPlex USA). They are expanding CDMO services and manufacturing capacity to meet global biologics demand, with multiple manufacturing sites.

mAbxience

Spain

mAbxience, a Fresenius entity, is a global CDMO with 14+ years of experience in the development and manufacture of biopharmaceuticals, specializing in biosimilars and monoclonal antibodies. They are FDA-registered with two FEI numbers for analysis and API manufacture. They have partnered with HP to develop AI solutions for optimizing monoclonal antibody and biosimilar production. Their CDMO platform offers tailored solutions with quality, agility, and flexibility in manufacturing.

MassBiologics, a division of UMass Chan Medical School, is a US-based biologics CDMO with over 100 years of history driving discoveries to products. The organization develops novel biologics for diseases of public health importance and offers CMO services including bulk drug manufacture of monoclonal antibodies, vectored therapeutics (gene therapy), and aseptic fill finish. The facility includes approximately 25,000 sq ft of cGMP manufacturing space with dedicated aseptic fill finish and bulk drug substance areas. FDA-registered with 3 FEI numbers. Produces the FDA-licensed Td vaccine and has partnerships for gene therapy manufacturing (SparingVision, PTC Therapeutics).

National Resilience Inc.

Canada

Major North American biomanufacturing CDMO (branded as 'Resilience') focused on complex medicines including large molecule biologics, cell therapies, and aseptic drug product manufacturing. Operates facilities across the US and Canada. Delivers 100+ million vials and pre-filled syringes annually. Secured $825 million in financing to accelerate CDMO strategy. Offers proprietary technology platforms including Sprout Solutions, Auto-T, DAR-T (next-gen CAR-T), and Idea to Clinic services. FDA registered with 7 FEI numbers, 17 inspections.

NovaCina is a sterile injectable CDMO based in Perth, Western Australia, launched by Bridgewest Group. The company manufactures sterile injectable drug products for all phases from development through commercial production. NovaCina has expanded its facility with a high-tech SA25 GMP filling line for small-batch sizes and has since merged with BioCina to create an end-to-end CDMO offering integrated biopharmaceutical and small molecule contract manufacturing services.

Oman Pharmaceutical Products Co. LLC is a pharmaceutical manufacturer based in Salalah, Oman, engaged in inhouse formulation manufacturing, out-licensing, and CDMO business. The company produces oral solid dosage forms including tablets and offers contract manufacturing services to partners in the region and beyond.

Polymun Scientific Immunbiologische Forschung GmbH is an Austrian specialist CDMO in biopharmaceuticals and liposomal/lipid nanoparticle (LNP) formulations. Offers contract development and manufacturing from gene to clinical grade material for innovator and biosimilar products. Unique expertise in liposomal drug formulations that protect, transport, and release drugs at target sites. Also maintains R&D projects including liposomal superoxide dismutase, recombinant porcine trypsin, and HIV antibodies/antigens. FDA registered for analysis, API manufacture, and manufacture.

ReciBioPharm (now Recipharm Advanced Bio) is the advanced therapies division of Recipharm, a global CDMO devoted to process development and GMP manufacturing for advanced therapeutics including xRNA therapies, viral vectors, microbial/live biotherapeutic products, and recombinant proteins. They offer end-to-end services from preclinical development to commercial manufacturing, with operations on two continents. They have partnerships with the University of Oxford, NewBiologix (AAV cell lines), LenioBio, and Hongene Biotech.

Repsol Química, S.A.

Spain

Repsol Quimica S.A. is the chemical division of Repsol, a major Spanish energy company. The division manufactures petrochemicals and specialty polymers at large-scale industrial complexes in Spain and Portugal. While they produce chemical products used in healthcare and pharmaceutical packaging (polymers), they are a raw material and polymer supplier, not a pharmaceutical contract manufacturer.

Sciencix

United States

Sciencix is a US-based ISO 9001:2015 certified manufacturer of HPLC and mass spectrometry replacement parts and accessories, founded in 1985. The company serves pharmaceutical, environmental, and other analytical laboratory markets with replacement components for chromatography and mass spectrometry instruments.

Scientia Clinical Research

Australia

Scientia Clinical Research is an Australian contract research organization providing clinical trial services. The company operates a clinical research facility at the University of New South Wales (UNSW) Randwick Hospitals Campus and provides clinical development and business development services for pharmaceutical and biotech companies.

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.

Stelis Biopharma is a leading, fully integrated biopharmaceutical CDMO based in India (Bangalore) with over 30 years of operational excellence. They brand themselves as 'OneSource' -- a multimodal specialty pharma CDMO with end-to-end capabilities across multiple tech platforms and therapeutic modalities. Their capabilities span biologics (microbial and mammalian cell culture, drug substance and drug product), complex sterile injectables (35 approved ANDAs and 19 commercialized drug products in the US), drug-device combinations (20+ automatic/semi-automatic assembly stations for prefilled syringes, pen injectors, autoinjectors), and soft gelatin capsules (2.4 billion per year capacity). They operate 5 state-of-the-art facilities approved by various regulatory bodies. Syngene acquired Stelis Biopharma's Unit 3 plant in Bangalore for biologics manufacturing.

Symetal S.A.

Greece

Symetal S.A. is a Greek manufacturer of aluminium foil products, primarily for pharmaceutical packaging applications including blister foil and lacquered foil. The company is part of the ElvalHalcor group and is certified under the Aluminium Stewardship Initiative (ASI) Performance Standard. Symetal supplies packaging materials to the pharmaceutical industry but does not manufacture drugs or drug products.

Synergy Innovation Inc. is a US-based company that leverages technology to transform manufacturing processes, providing high-speed assembly lines and non-destructive inspection systems. No website is available and search results do not indicate pharmaceutical drug manufacturing. The company appears to be an equipment/technology supplier rather than a CDMO.

uBriGene Biosciences Inc is the same entity as uBriGene (duplicate entry, different ID). This is the China-headquartered entity of the same global CRDMO providing one-stop viral vector-based CDMO services for research and clinical applications. Series C+ funding of 150M CNY (~$20M USD). Same website, same capabilities. See uBriGene entry (ID 10a6a05c) for full details.

Vigene Biosciences is a gene therapy CDMO acquired by Charles River Laboratories for up to $350M to enhance gene therapy capabilities. The company specializes in AAV viral vector manufacturing. Website content was blocked (Cloudflare), but search results confirm the company engages in producing AAV vectors for gene therapy programs. Now operates as part of Charles River's cell and gene therapy platform.

BSV BioScience GmbH is a German CDMO specializing in biological API manufacturing, providing contract development and manufacturing services for biologics drug substances. The company is FDA-registered for API manufacture and offers process development, analytical services, and cGMP manufacturing for biopharmaceutical clients.

Dubourgel Medical is a French company specializing in the design and manufacture of medical devices for various medical procedures including hyaluronic acid injection syringe accessories, blood analysis tools, surgical instruments, and orthopedic devices. The company is not a pharmaceutical drug manufacturer.

Dynage is an Italian company that manufactures pharmaceutical production equipment including mixers, dissolvers, stainless steel bins and drums for API handling, ointment manufacturing plants, intra-vaginal ring production lines, and other pharmaceutical processing machinery. It supplies equipment to pharma manufacturers, not drug manufacturing services.

ExcellGene SA is a Switzerland-based biologics CDMO specializing in custom protein expression and large molecule biologics development and manufacture. The company offers cGMP Master Cell Bank manufacturing and has partnered with Cytovance Biologics to advance biologics development and manufacturing capabilities.

GenIbet is a Portuguese biologics CDMO acquired by Recipharm (now operating as Recipharm Advanced Bio), specializing in advanced therapy medicinal products (ATMPs) including xRNA therapies, viral vectors, microbial and live biotherapeutic products, and recombinant proteins. The company provides end-to-end preclinical development and commercial manufacturing capabilities for biotherapeutics. GenIbet holds FDA registration and has been inspected by the FDA.

GSA Medical INC. is a US-based product development and manufacturing company focused on rapid immunoassay diagnostic products. The company's corporate mission is to provide quality rapid immunoassay products; it does not appear to provide pharmaceutical contract manufacturing services.

Olon SpA is a global leader in the development and production of Active Pharmaceutical Ingredients (APIs) for CDMO and generic markets, integrating chemical synthesis and microbial biomanufacturing. The company operates 14 GMP facilities primarily in Italy, with additional sites in France (via GTP Bioways acquisition), the US, Germany, and China, with 450+ DMFs and 35+ years of regulatory experience.

Pharma Line S.r.l. is an Italian pharmaceutical company specializing in medical devices and food supplements since 1987. While listed on PharmaSource under CDMO/finished dosage forms, the company's own website is a parked domain with no manufacturing evidence. The primary business appears to be medical devices and nutraceutical supplements, not contract drug manufacturing.

Pharma Links (UAE) is a pharmaceutical supplier serving as a one-stop-shop for pharmaceutical formulators worldwide. Based on search results, the company acts as a distributor and indenting company for pharmaceutical raw materials and APIs rather than a drug manufacturer. No website content was available for verification.