A full list of contract cGMP manufacturers/companies (CMO) offering broad range of GMP manufacturing services for biotechnology and pharmaceutical industry including cell line development, cell banking, process development, GMP production, antibody production and purification, regulatory support, validation and product management.
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A-Bio Pharma Pte Ltd - Gemini, Singapore
Company Profile: Project Kick-Off, Cell Line Development, Process Development, Process Transfer to GMP Production, GMP Production, Regulatory Support.
Advanced BioScience
Laboratories, Inc. -
Kensington, Maryland, USA
Company Profile: Contract cGMP BioManufacturing. ABL core resource expertise include Quality, Scientific, cGMP Manufacturing, Regulatory Affairs, Validation and Project Management.
Affinity Life Sciences - Milford, New Hampshire, USA
Company Profile: a cGMP and ISO 13485 compliant company and is dedicated to the specific needs of the biotechnology and pharmaceutical markets. Our cGMP facility can provide custom services including in vitro diagnostic kit production, reagent formulation, vial filling and labeling, kit assembly and labeling, and microplate coating of proteins, nucleic acids, cells, or other target molecules.
http://www.affinitylifesciences.com/
Alchem Laboratories Corporation -
Alachua, Florida, USA
Company Profile:
a contract research organization
specializing in custom synthesis of novel organic compounds and fine
organic chemicals. We also offer cGMP manufacturing of active
pharmaceutical ingredients for pre-clinical and clinical studies.
Alpha Biologics - Babraham, Cambridge, United Kingdom
Company Profile: an independent contract biomanufacturing organisation offering FDA/EMEA cGMP compliant services to the worldwide pharmaceutical and biotechnology industry. Alpha specialises in process development, production and purification of mammalian cell secreted protein drugs, providing the services required to deliver our clients' drugs in full compliance with cGMP guidelines.
http://www.alphabiologics.com/
AmbioPharm, Inc. - North Augusta, South Carolina, USA
Company Profile: Develops and provides contract manufacturing services for peptides and biopharmaceuticals at clinical and commercial scale. AmbioPharm has multiple manufacturing suites to produce peptide APIs on gram to kilogram scale either by solid phase peptide synthesis, solution phase peptide synthesis, or hybrid solid/solution phase synthesis.
BioUETIKON Limited -
Dublin, Ireland
Compass Pharma Services, LLC - Clifton, New Jersey, USA
Compass Pharma Services LLC is a cGMP-compliant contract packaging company located in Clifton, NJ. Compass packages solid dose preparations, liquids and powders into virtually all packaging forms including blister packages, unit dose blisters, pouches, bottles and cans.
Covance - Madison, WI, USA and Harrogate, UK
Covance has over 18 years of experience in providing cGMP analytical support to the pharmaceutical and biotechnology industries. We also offer specialized capabilities, such as experience with all dosage forms and delivery systems, nitrosamine analysis and expertise in the evaluation of protein-based products.
http://www.covance.com/gmppharmanalysis/index.php
Dalton Chemical Laboratories Inc. -
Toronto, Ontario, Canada
Company Profile:
Dalton is a
Glycotope Biotechnology GmbH - Heidelberg, Germany
Company Profile: Biotechnological GMP Production of Proteins - For the production of recombinant proteins, Glycotope Biotechnology has focussed on mammalian and insect cell expression systems. Our core competences are centered on development and production of glycoproteins and antibodies. Glycotope Biotechnology covers the complete process development starting from a research cell line up to the GMP production of recombinant proteins in multi-gram scale as active pharmaceutical ingredients (API).
Ion Labs, Inc. - Clearwater, Florida, USA
Company Profile: Ion Labs can help you develop, formulate, and manufacture quality products. We offer complete laboratory testing, quality testing of all ingredients, and turn-key manufacturing.
Microbix Biosystems Inc. - Toronto,
Ontario, Canada
Company Profile:
Microbix is a biotechnology
company specializing in the development of biologics including
multi-source (generic) biotherapeutic drugs, vaccines and other high
value biologics based on specialized core competencies in cell
culture, virology, protein purification, characterization and
production scale-up, which forms our "technology platform". Use our
experienced staff and established cGMP facility. We have versatile
space, qualified utilities and support equipment and trained staff.
Nextar chempharma solutions -
Ness Ziona, Israel
NutraScience Labs - Farmingdale, New York, USA
Company Profile: Whether you're just starting your supplement company or whether you've been in the business for years, we can help you with all aspects of your vitamin manufacturer needs. Find out how we can maximize your return on investment with our vitamin supplement manufacturer solutions and our storage, packaging, and delivery options. NutraScience Labs offers a full line of vitamin manufacturer services to suit your needs.
https://www.nutrasciencelabs.com/
Pharmatek Laboratories, Inc. - San Diego, California, USA
Company Profile: Specialization in Phase I/II manufacturing provides a unique advantage to clients seeking to manufacture clinical supply material using current Good Manufacturing Practices with necessary regulatory compliance. Pharmatek's focus on early phase development enable us to be flexible and responsive to your manufacturing needs. Clients can depend on on-time delivery of clinical trail materials and trouble-free technical transfer for phase III and commercial scale-up.
Regis Technologies, Inc. - Morton Grove, Illinois, USA
Company Profile: Regis plays a vital role in the pharmaceutical industry by developing commercially viable chemical processes and producing active pharmaceutical ingredients (APIs) for preclinical, clinical, and small to medium scale commercial use under current Good Manufacturing Practices (GMPs)
SCM Pharma Limited - Northumberland, England
Company Profile: Within our cGMP site, we offer you both sterile and non-sterile services that take place in our class (C) 10,000 cleanroom, created to provide flexibility to meet your individual needs. Please browse the links on the left hand side to find out more information about our specialist services.
SynCo Bio Partners B.V. - Amsterdam, The Netherlands
Company Profile: a GMP contract manufacturing organization offering a fully integrated range of services in biopharmaceutical manufacturing and supports companies from the earliest stage in process development, through clinical trials to market supply. With a track record of expertise in the production of recombinant proteins and vaccines, SynCo collaborates with a number of leading Biotech and Pharmaceutical companies worldwide.
Waisman Biomanufacturing - Madison, Wisconsin, USA
Company Profile: A state-of-the-art cleanroom facility that is equipped with experienced staff and specialized equipment that are necessary for cGMP manufacturing of cell therapeutics, gene therapy vectors, and biologics for phase I/II human clinical trials. The primary mission of Waisman Biomanufacturing is to serve researchers and business ventures as they enter early development of novel biological therapies and vaccines and to catalyze the advancement of these products into human clinical trials.
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