Here
is a list of over 60 contract antibody suppliers who will take your
research grade antibody and scale it up for clinical use or for use in
a diagnostic assay, usually under GMP or cGMP guidelines. These
companies specialize in both the development and large scale production
of polyclonal and/or monoclonal antibodies.
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AbD Serotec - (monoclonal) - custom monoclonal antibody production from 10 mgs to 10 grams – ISO 9001 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) - capabilities include the discovery of therapeutic antibodies and the
development and manufacturing of critical reagent ancillary antibodies
and assays required for drug development, e.g. anti-idiotype and PK
study antibodies. High quality well documented production up to
several grams.
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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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Bio X Cell - (monoclonal)
- custom fermentation and purification services for the production of
monoclonal antibodies in hybridoma cells. They use stirred tank
fermenters and wavebag systems. Production ranges from 5 to 500 L.
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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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
- BluePoint Bioscience - contract developer and manufacturer of mouse monoclonal antibodies using in vitro cell culture systems: hybridoma development, production, and cell culture services
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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)
- CMC Biologics
- specializing in the development and production of antibodies
using both mammalian and microbial cell culture technologies. Their
platform technologies (CHEF1 cell line construction, analytical
package, scale-up (from 5L directly to cGMP 750L bioreactor)) allow CMC
to produce clinical material within 7 months.
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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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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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Europa Bioproducts - (monoclonal, polyclonal) - able to produce IgY chicken antibodies from research quantities to industrial scale in a GMP facility.
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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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Florida Biologix
- a non-profit cGMP contract testing and manufacturing
organization that can help you produce, test, bank
and/or fill antibodies for pre-clinical, Phase I, or Phase II
clinical trials.
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Formatech - (monoclonal, polyclonal)
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Fusion Antibodies - offering a full development package from proof of concept through to cGMP scale up
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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.
- Genhelix - (monoclonal)
- A cGMP facility with cellular fermentation, production, and purification capabilities
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Harlan - (monoclonal, polyclonal)
- monoclonal antibody production for use in diagnostic or therapeutic
applications can be performed in their cGMP, FDA-registered facility or
can be performed under non-cGMP conditions to save time and reduce
costs. Polyclonal production in rabbits, goats/sheep, mice, rats,
etc... and other services including peptide synthesis, conjugation,
purification, and hybridoma development are available.
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Novasep - (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.
- Icosagen - (monoclonal)
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ImmunoReagents -(polyclonal)
- large-scale manufacturer of polyclonal antibodies (to human proteins) for use in research and in vitro diagnostics
- 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)
- They offer a wide range of services including the development and
production of monoclonal antibodies (from 1 mg to 1 kg), recombinant
proteins for diagnostic and pre-clinical use, cell line development,
and transient transfection. They also offer the production of
monoclonal antibodies under serum-free conditions which can avoid the
drawbacks of serum based processes.
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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 - expertise at developing and producing antibodies via
mammalian cell culture and microbial fermentation. They offer a
range of services including cell line construction, protein design and
engineering, process development, scale-up and production.
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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
Meridan Life Science - (monoclonal)
- large scale in vivo and in vitro mAb production in a ISO 9001:2008 Certified and EC1774/2002 Approved Facility
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MicroPharm - (polyclonal)
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Miltenyi Bioprocess - (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.
- Operon
- large-scale production and purification (from a few hundred milligrams to dozens of grams) for the in vitro immunodiagnostics industry
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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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P.A.R.I.S - (monoclonal) - in vitro production on the large-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)
- mammalian/vertebrate, higher-producing cell engineering, non-GMP/GMP
manufacturing of antibodies including lead optimization, cell banking,
and process development. They have established various analytical
methods and cell-based assays like ADCC to measure product quality and
provide project management as well as regulatory support.
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Proteodynamics
- a provider of LP compliant analytical services for characterization
and validation of antibodies and other proteins according to ICH
guidelines. Services for primary characterization and batch-to-batch
comparison include analysis of the intact molecule, peptide mapping,
N-terminal, and MS sequencing, analysis of PTM, including full
characterization of glycosylation profiles.
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PX'Therapeutics - (monoclonal)
- PX’Monoclonals is a technology platform dedicated to custom
manufacturing and engineering of high affinity monoclonal
antibodies for therapeutic, diagnostic, and cGMP analytical development
applications
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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.
- Sino Biological
- large scale antibody production and purification services from
hybridoma culture, transient transfection, and stable cell lines up to
a 100 gram scale
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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
- Syd Labs - large scale antibody production and purification for diagnostic or therapeutic applications
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Syngene
- Providers of cGMP and non-GMP production services for proteins and
antibody products for pre-clinical and clinical Phase I and II
materials. Their contract manufacturing services cover cGMP
manufacturing and quality control of biopharmaceutical products based
on microbial and mammalian expression technologies including batch,
fed-batch, and perfusion technologies.
- 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.
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Xcellerex - (monoclonal)
- contract manufacturing services expressing recombinant monoclonal
antibodies, vaccines and proteins for therapeutic use in all phases of
clinical trials. They have both non-cGMP and a cGMP facility that
contains stirred tank bioreactors from 50L up to 2,000L supported by
process development and downstream purification groups.