As a contract manufacturing organization (CMO), Cobra supports the global life sciences industry in the fill and finish of small molecules and biologics. A fully comprehensive pharmaceuticals and biologics service offering is also provided for monoclonal antibodies (mAbs), recombinant proteins, DNA, viruses, phage and cell line derived products. Multi-functional and experienced project teams nurture customers' products through to clinical and commercial manufacture at our three GMP-approved facilities in Sweden and the UK.
A track record of over 16 years producing biologics and pharmaceuticals for use in pre-clinical to Phase III clinical trials and commercial supply has given our team a unique knowledge base as both a manufacturer and service provider for the global life sciences market. We offer a broad range of integrated and stand-alone development services, stretching from cell line development to the supply of investigational medicinal products for clinical trials and commercial market supply.
Every programme complies with cGMP standards worldwide and is conceived with an unmatched quality derived from the know-how of Cobra's highly qualified, flexible and dedicated people. We take pride in manufacturing excellence, delivering what we promise and helping our customers to develop drugs for the benefit of patients.
Cobra has three GMP approved facilities; in Sweden our fill finish and microbial-based protein production facility in Matfors, and our mammalian production facility in Södertälje, and in the UK our microbial and virus production facility located in Keele. Our sites offer a comprehensive service to support your project from conception to fill finish.
Our state-of-the-art, flexible fill finish facility, acquired by Cobra from UniTech Pharma at the end of 2011, expands our service offering to include the production of sterile drug products and freeze drying/lyophilisation. Small molecules can be filled in either single-use syringes or injected vials at a rate of up to 4,000 units an hour, meeting rigorous sterility requirements in accordance with aseptic manufacturing procedures.
With a steadfast track record and commercial contracts with companies including an emerging leader in specialty pharmaceuticals, Cobra has experience in the supply of parenteral products for both clinical trials and commercial, in-market supply.
With batch sizes from 1-100L, Cobra can manufacture for clinical through to commercial scale supply, with parenteral products filled in single-use syringes (0.5-10ml) or injected vials (2-100ml), with the capabilities for terminal sterilisation by autoclave, if required.
All batch records are fully traceable under QA observation with QP review and issue of cGMP Certificate of Compliance, and regulatory documents are reviewed as required to support product release to clinic. Primary labelling of drug product vials for human clinical centres, secondary packaging and labelling of vials for dispatch to clinical centres, and tertiary and transport labelling and packaging can also be arranged according to regulatory requirements.
To complement our comprehensive service offering, Cobra provides customers with the opportunity to take advantage of a selection of stand-alone services including cell line development, cell banking, stability testing, protein characterisation, bioassays, analytical services, and sterile drug product fill and finish.
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