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AbD Serotec - (monoclonal) - custom monoclonal antibody production from 10 mgs to 10 grams – ISO certified facility
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A-Bio - (monoclonal) - a cGMP mammalian cell culture manufacturing facility in Singapore with a focus on producing therapeutic monoclonal antibodies for clinical trials. The facility is qualified to meet US FDA (www.fda.gov) and European EMEA (www.emea.eu.int) GMP guidelines.
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Adar Biotech - (monoclonal) - production and purification of monoclonal antibodies (up to 10 grams) in serum-free media
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Aeres - (monoclonal) - contract services to produce humanised antibodies via CDR-grafting. They will also generate stable mammalian cell lines expressing recombinant antibodies for therapeutic use and offer other antibody engineering services.
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Affinity Life Sciences - (monoclonal, polyclonal) - a GMP facility that can provide custom services including in vitro diagnostic kit production, reagent formulation, vial filling and labeling, kit assembly and labeling, and microplate coating of target molecules. They can also provide monoclonal and polyclonal antibody development, antibody purification and conjugation, as well as assistance in immunoassay design, development, production, and commercialization.
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Agri-Bio - (monoclonal, polyclonal) - provider of antisera and antibodies for the diagnostic industry
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Alpha Biologics - (monoclonal) - a cGMP compliant contract manufacturer of mammalian cell secreted biologics for use in pre-clinical, Phase I, Phase II, and Phase III clinical trials for the global market. Alpha specializes in master and manufacturing cell bank generation, process development, and cGMP production and purification in a 5,000 m2 US FDA design reviewed facility.
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Anaspec - (monoclonal)
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Antibody Solutions - (monoclonal, polyclonal) - developer and manufacturer of novel antibodies offering a complete range of antibody services with a performance guarantee.
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Anogen - (monoclonal) - contract manufacture, developer, and supplier of antibodies for research, diagnostic and therapeutic use
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Antitope - manufacturers of mammalian cell lines producing high levels of humanized antibodies for clinical trials
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Abpro - (monoclonal) - production of monoclonal antibodies in up to gram quantities
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Apolife - (monoclonal) - a contract R&D company providing custom production of recombinant monoclonal antibodies and fusion proteins using variety of organisms including yeast. Their"Twin Cassette" technology is used to produce cost effective recombinant products using automated 10 L fermenters.
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Avid Bioservices - (monoclonal) - contract manufacturing services utilizing mammalian cell lines expressing recombinant monoclonal antibodies and proteins for therapeutic use in all phases of clinical trials including commercial production and for diagnostic applications. A cGMP facility contains stirred tank mammalian cell bioreactors from 30L up to 300L and is supported by process development and downstream purification groups. Bulk filling services are also offered.
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Aves Lab - specializing in chicken (IgY) antibodies, they are a large-scale provider of antibody products and custom antibody services
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Bethyl Laboratories - (polyclonal) - 30 years experience in producing antisera and antibody products for the diagnostic industry
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Biocult - (monoclonal) - ISO-9002 certified and capable of pilot production, establishing of cell banks, and the manufacture of product for clinical (Phase I) studies according to GMP guidelines
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Bio Express - (monoclonal) - supplies researchers in academia, pharmaceutical and diagnostic industry with pre-clinical grade monoclonal antibodies and recombinant proteins expressed in systems such as CHO, NS0, HEK293, BVES, E. Coli, and hybridomas (rat, mouse, hamster)
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BioGenes - (monoclonal, polyclonal, immunoassays) - BioGenes gives a guarantee for monoclonal and polyclonal antibodies. They develop stable monoclonal antibody cell lines within 3-4 months and need just 0.2 mg of protein for the whole development. All results and clones become the property of the customer. They also offer contract services for development, validation and production of immunoassays.
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BioInvent Production - (monoclonal) - a large scale contract manufacturer of mammalian cell derived proteins. Contracted output includes different monoclonal antibodies and recombinant proteins for therapeutic use in all phases of clinical trials in the US and Europe.
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BioProcessing - (monoclonal) - monoclonal antibodies and diagnostic control serums for clinically approved and novel immuno-assays. In addition, BioProcessing also provides contract hybridoma and large-scale cell culture services for the biotechnology industry.
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BioProtein - (monoclonal)
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Bioreliance - (monoclonal) - offers a full range of services for the testing of monoclonal antibody-based products from early preclinical development to licensed product.
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Biosynergy Europe - (monoclonal) - offering cell line evaluation, optimization, process validation, production, downstream processing and assay development. Production scale ranges from milligram to multi-gram using roller, spinner, and hollow fibre technologies.
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Cambrex Biopharmaceutical Business Unit - (monoclonal) - provides process development, analytical, and cGMP manufacturing services for scale-up and commercial production of monoclonal antibodies
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Capralogics - (polyclonal) - high volume production of serums for research, discovery, and diagnostic applications. USDA certified "scrapie-free" goats dedicated for diagnostic antibody production. Approved EU collection facility.
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Cell Essentials - (monoclonal) - contract hybridoma development as well as large scale monoclonal antibody production and purification using roller bottles, spinner flasks and stirred-tank bioreactors
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Charles River Laboratories - (monoclonal, polyclonal)
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Covance Research Products - (monoclonal, polyclonal) - Covance Research Products is a provider of antibody products and custom antibody services. Custom services include hybridoma development, ascites and in vitro scale up, and associated immunochemistry (e.g., purification, characterization, and conjugation).
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Creative Biolabs - (monoclonal) - mAb bioreactor production up to 100 grams
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DaTaMabs - an antibody engineering consultancy company which offers design services for humanizing therapeutic monoclonal antibodies
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Diatec - (monoclonal) - contract production of antibodies from 50 mg to 30 grams with larger volumes available upon request. In vitro production is used.
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Fapon - (monoclonal, polyclonal) - a raw material supplier for both in vitro diagnostic and research fields. They develop and manufacture monoclonal and polyclonal antibodies (mouse, rabbit, or chicken) and recombinant antigens using in vivo methods. The products they develop can be used in ELISAs, rapid tests, and for Western blots.
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Formatech - (monoclonal, polyclonal)
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Gala Biotech - (monoclonal) - platform technology that can produce high expressing, stable mammalian cell lines starting with antibody subunit cDNA. Gala can also carry out contract manufacture of Phase I/II cGMP material.
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Gallus Immunotech - (polyclonal) - can produce chickent antibodies on an industrial scale and in a GMP facility
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Goodwin Biotechnology - (monoclonal) - GBI is a fully integrated contract manufacturer of diagnostic and clinical biologics. They assist clients in managing risk, expediting product approval, and controlling costs by providing services from cell banking and process development to final vialed product, cost effective manufacturing strategies, analytical testing, and regulatory support.
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Harlan Bioproducts For Science - (monoclonal, polyclonal) - large-scale, in vivo and in vitro monoclonal antibody production under cGMP and research guidelines. Polyclonal production in rabbits, goats/sheep, mice, rats, etc... Other services include peptide synthesis, conjugation, purification, and hybridoma development.
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Henogen - (monoclonal) - a Belgian cGMP contract manufacturing company that offers cell line and process development, cGMP production up to a 300L scale, purification, fill and finish, and phase I and II clinical trial assistance.
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Inno Biologics - (monoclonal) - a cGMP contract manufacturing facility which produces monoclonal antibodies using mammalian cells for pre-clinical, phase I, II and III. Located in Malaysia, they also offer services like gene cloning, protein expression, cell banking, and process development. The facility is designed to meet US FDA and EMEA standards.
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InVivo Biotech - (monoclonal) -contract production of monoclonal antibodies from 10 mg to 100 grams for research or diagnostic use. Beside cultivation in stirred tank bioreactors using proprietary serum-free media InVivo will also generate recombinant mammalian cell lines
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KBI BioPharma - (monoclonal) - GMP compliant human therapeutic and vaccine products with the capabilities for the custom production and purification of monoclonal antibodies for diagnostic use
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Lampire Biological Laboratories - (monoclonal) - in vitro, from research to bulk lots. Other services include hybridoma development, cell line optimization, serum-free production, supernatant concentration and purification
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Laureate Pharma - (monoclonal) - development and cGMP manufacture of monoclonal antibodies for clinical use. They provide a wide range of product development services from process design and development to full-scale cGMP production, purification and aseptic filling, as well as corresponding analytical services and regulatory support.
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Leinco - (monoclonal) - monoclonal antibody development and in vitro production up to kilogram quantities. Low endotoxin in vivo functional formulation and purification is also available.
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Lonza Biologics
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Maine Biotechnology Services - (monoclonal, polyclonal, peptides) - Custom cGMP monoclonal and polyclonal antibody production & development, including in vitro and ascites production methods. Additional services include purification, affinity purification, and conjugation.
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Medicago - (monoclonal) - a ISO 9001 facility capable of monoclonal antibody production and purification under GMP standards
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Medix Biochemica - (monoclonal) - production of monoclonal antibodies from a few hundred milligrams to hundreds of grams for the in-vitro immunodiagnostics industry
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MicroPharm - (polyclonal)
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Miltenyi Bioprocess (industrial service division) - (monoclonal) - cGMP mammalian and hybridoma cell culture manufacturing. They offer cell bank production and storage, process development, cGMP production in up to 200 L scale bioreactors, purification, fill and finish (with optional lyophilization) for clinical trials
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M-Scan - located in the UK, Switzerland, US, and Germany. A GLP/cGMP, FDA inspected contract laboratory with a core competence in antibody protein and carbohydrate chemical analysis according to ICH guidelines. Services range from intact molecular weight determination, MS peptide mapping, extensive glycan characterisation, isoform characterisation up to the de-novo sequencing of antibodies.
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OEM Concepts - (monoclonal) - offers contract ascites production of monoclonal antibodies as well as in-vitro production in bioreactors. They also offer polyclonal antibodies and their related antigens and conjugates, this in addition to their capabilities for large scale purification by a variety of methods.
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ORPEGEN Pharma - (monoclonal) - regulatory compliant (GMP) production of antibodies from custom provided hybridoma or recombinant cells
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PacificGMP - (monoclonal) - provides development and cGMP production services for recombinant antibodies and proteins. They specialize in using disposable technologies and Wave Bioreactors from 10 to 1000 liter batch sizes or on the perfusion scale.
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Polymun Scientific - (monoclonal) - contract development and manufacturing with a focus on mammalian cell technology in protein-free expression and production systems. Optimization of product yield during cell line establishment and by process development. Production of GMP-compliant biopharmaceuticals.
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ProBioGen - (monoclonal) - custom manufacturing of monoclonal antibodies in GMP and non-GMP quality with 11 years of experience and over 300 customer cell lines processed. CHO cell line and process development services are also offered.
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RD-BIOTECH - (monoclonal) - custom developement and multigram production of monoclonal antibodies by ascites or in vitro methods. Generation of stable mammalian cell lines expressing recombinant antibodies for therapeutic uses. In addition, they offer purification, coupling, and ELISA development services.
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Southern Biotechnology Associates - (monoclonal, polyclonal)
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Strategic Diagnostics - (monoclonal, polyclonal) - antibodies are produced using in vivo (ascites) and in vitro (roller bottle) methods under cGMP guidelines
- TGA Sciences - (monoclonal) - offering customized immunoassay development and validation (GLP and cGMP) in addition to in vivo animal studies, immunogenicity testing, and monoclonal antibody production.