Biologics Drug Substance CDMOs

Budenheim (Chemische Fabrik Budenheim) is a German specialty chemicals company that manufactures phosphate-based pharmaceutical excipients, primarily the DI-CAFOS range of calcium phosphate products used as tablet excipients. The company holds EXCiPACT GMP certification and FDA registration but supplies raw materials to pharmaceutical manufacturers rather than manufacturing drugs itself.

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.

Eubioco is a Polish contract development and manufacturing organization (CDMO) offering contract manufacturing of medicines, supplements, and veterinary products. The company has an office and production complex in Dywity and employs more than 150 people, with capabilities spanning pharmaceutical and nutraceutical liquid and semi-solid forms.

Kaneka Eurogentec (part of Kaneka Group, Japan) is a Belgian CDMO established in 1985, FDA inspected, GMP accredited. Manufactures starting materials and APIs for clinical and commercial phases. Core products: GMP plasmid DNA (gram to kg scale), GMP recombinant proteins and antibody fragments, GMP mRNA (50g per batch, commercial-ready facility accredited June 2025), GMP oligonucleotides (pre-clinical and Phase 1/2), GMP conjugates. Also supplies research-grade oligonucleotides and diagnostic tools. 475 employees. FDA registered with 2 FEI numbers, 7 inspections (1 NAI, 6 VAI). Plasmid DNA serves as starting material for viral vector and mRNA production.

Gellycle Co., Ltd. is a Japanese company developing innovative technologies for controlling the physical properties of hydrogels, operating a platform-type business providing hydrogel solutions. The company participates in pharma industry events (INTERPHEX Tokyo) and Swiss Biotech Days, but appears to be a technology/materials company rather than a contract drug manufacturer.

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.

Kirsch Pharma HealthCare GmbH is a German company focused on pharmaceutical raw materials sourcing and production, and production technologies (refining and mixing). Their website indicates services in pharmaceutical sourcing and production of raw materials. A related entity, Kirsch BioPharm, appears to be building biopharma manufacturing capabilities, but Kirsch Pharma HealthCare itself is primarily a pharmaceutical raw material and excipient supplier rather than a CDMO. Without website text or detailed evidence of contract drug manufacturing, they are classified as a raw material supplier.

Loopworm is an Indian agri-biotechnology startup focused on insect protein production, operating a 6,000-tonne-per-year insect processing facility in Bengaluru. The company produces proteins and oils from silkworms and black soldier flies for agricultural and food applications. Loopworm is not a pharmaceutical company or CDMO.

Manac Incorporated is a Japanese chemical manufacturer established in 1948, recognized as the top manufacturer of bromine and iodine compounds in Japan. The company supplies pharmaceutical intermediates and fine chemicals to the pharma industry, exhibiting at CPHI and Chemspec trade shows. Manac provides chemical building blocks used in API synthesis but does not itself manufacture pharmaceutical APIs or finished drug products on a contract basis.

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.

LucasPye BIO (LPB) is a US-based CDMO focused on accelerating biotherapeutic innovation. They offer comprehensive biopharmaceutical development and manufacturing solutions including cell line development, upstream/downstream process development, and cGMP manufacturing of biologics. They aim to bring down CDMO costs through strategic vendor partnerships to make biotherapeutics more affordable.

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.

eFortless Bio is a US-based company with no accessible website and minimal publicly available information. Search results return only unrelated companies (Fortis Life Sciences, Evotec). No evidence of drug manufacturing, CDMO, or CRO activities exists in available sources.

TDS Med (Total Drug Supply) appears to be a pharmaceutical services or CDMO company based in the United States, but no website content was available for analysis and search results provide only minimal information (company name, PharmaSource listing, generic 'CDMO' mention). Without verifiable evidence of specific capabilities, services, or manufacturing operations, no capabilities can be assigned.