Cell & Gene Therapy CDMOs

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.

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.

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.

Life Edit Therapeutics

United States

Life Edit Therapeutics is a gene editing R&D company and business unit of ElevateBio, focused on discovering and developing novel gene editing tools and technologies. The company collaborates with pharmaceutical companies like Novo Nordisk and Moderna on gene editing research. Life Edit is not a contract manufacturer; it is an internal R&D platform within ElevateBio.

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.

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.

SK Pharmteco is a leading global CDMO providing drug development and manufacturing services across small molecules, gene therapy, and analytical testing. The company operates cGMP facilities in the United States (240-acre California headquarters in Rancho Cordova, King of Prussia PA), Ireland (Dublin - 60+ years of API production), South Korea, and France. They offer custom API manufacturing including HPAPIs, viral vector manufacturing (lentivirus via LentiSure and AAV via AAVelocity platforms, 230+ batches manufactured, 100+ supporting clinical trials), plasmid DNA manufacturing, and analytical services. Recently invested in expanding peptide development capabilities and opened a new HPAPI testing lab.

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.

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.

Chongqing Southwest No.2 Pharmaceutical Factory Co., Ltd. is a Chinese pharmaceutical manufacturer with an FDA-registered 3,600 sq.m. facility producing innovative APIs. The company has connections to Porton Pharma's leadership and appears in industry reports as a small molecule API 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.

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.

Genuone Sciences Inc. is a South Korean pharmaceutical CDMO valued at approximately $752 million, offering specialized contract development and manufacturing services including formulation development through finished product production. The company provides pharmaceutical manufacturing and analytical services for both domestic and international clients. Genuone is 100% owned by IMM Private Equity.

Lykan Bioscience

United Kingdom

Lykan Bioscience is a CDMO focused exclusively on cell-based therapies, located in Hopkinton, Massachusetts. They have merged with RoslinCT (Scotland-based) to form a global advanced therapies CDMO. Their facility is purpose-built for cGMP cell therapy manufacturing, featuring ISO 7 cleanrooms. They announced a 90% capacity expansion and added six new cGMP manufacturing suites. They have been granted a MIA License for cGMP manufacturing.

Aliri Bioanalysis is a bioanalytical services company. No website content was available for detailed extraction, but the company name suggests contract research/bioanalytical testing services rather than drug manufacturing.

Bio-Techne is a global life science company providing high-quality reagents, instruments, and custom manufacturing services through its family of brands. The company offers custom antibody production, protein manufacturing, ELISA kits, and analytical tools including the Simple Western platform. While listed on PharmaSource as a CDMO, Bio-Techne primarily operates as a reagent and tools supplier with custom biologics services.

Cytiva is a global life sciences company that provides bioprocessing equipment, technologies, and solutions to biopharmaceutical manufacturers. The company sells manufacturing platforms such as FlexFactory process trains and KUBio modular facilities, and operates Fast Trak service centers for process optimization. Cytiva is an equipment and technology supplier, not a contract manufacturer of drugs.

ITECO Engineering is an Italian company that manufactures pharmaceutical equipment including blister feeders and isolator systems. The company exhibits at Cosmofarma and CPHI events and is listed under engineering and cell and gene therapy isolator market segments on CPHI Online.

Mycenax Biotech is a Taiwan-based biologics CDMO specializing in the development and manufacturing of biosimilars, monoclonal antibodies, bispecific antibodies, ADCs, and cell & gene therapy-related products. The company provides integrated services spanning cell line development, process development, analytical services, GMP manufacturing, and regulatory support for global biotech and pharmaceutical partners. With expertise in mammalian cell culture and biologics manufacturing, Mycenax supports clients from early-stage development through commercial-scale production. The company has established GMP facilities in Taiwan and focuses on delivering flexible, high-quality manufacturing solutions for complex biologics and next-generation therapeutics.

Luina Bio, now rebranded as AcuraBio after acquisition by Dr. Glenn Haifer and Ampersand Capital Partners, is an Australian-origin biologics CDMO. They specialize in plasmid DNA CDMO services and have expanded cGMP capabilities using Cytiva purification technology to support mRNA and cell & gene therapies. Merged with RoslinCT to create a combined cell therapy CDMO.