Tuesday, 11 February 2014: Cobra Biologics, a leading international contract manufacturing organisation (CMO) of biologics and pharmaceuticals, is pleased to announce that its GMP Compliance Certification has been extended to include Quality Control (QC) testing and release of customers’ registered products for in-market supply.
Following an inspection at the company’s centre of excellence for mammalian antibody and recombinant protein production in Södertälje, Sweden, the Läkemedelsverket (Medical Products Agency) has considered that the facility complies with the principles and guidelines of Good Manufacturing Practice laid down in Commission Directive 2003/94/EC for Human Medicinal, and Investigational Medicinal, Products.
This enhanced certification for biological medicinal products encompasses the manufacturing of active substances by culture of mammalian cells, the storage of both mammalian and microbial cell banks, the release testing of protein for clinical trials, and now the quality control testing of registered products.
Peter Coleman, CEO Cobra Biologics, remarked: “Quality Control testing of registered products is a very important step for Cobra in becoming a recognised commercial supplier of antibodies and recombinant proteins. The future of the company is dependent on us securing commercial product manufacturing and the team have really put in every effort to secure the additional certification.”
For more information about Cobra Biologics, please contact Peter Coleman, CEO, on +44 (0)1782 714181 or email peter.coleman@cobrabio.com
For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0)207 861 3019 or email: t.jervis@defacto.com.
About Cobra Biologics
Cobra Biologics is a leading international contract manufacturing organisation (CMO) of biologics and pharmaceuticals for clinical and commercial supply. Cobra has three GMP approved facilities, each with expertise tailored to serving our customers around the world. We offer a broad range of integrated and stand-alone contract services, stretching from cell line and process development through to fill and finish for the supply of products for clinical trials and the commercial market. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop medicines for the benefit of patients. Cobra supplies manufacturing solutions to the pharmaceutical industry covering antibodies, recombinant proteins, viruses, phage, DNA, whole cell vaccines and therapeutics as well as biologics and small molecule API lyophilisation and fill finish.
For more information please visit our new website: www.cobrabio.com.
For media enquiries, please contact Tristan Jervis on +44 (0) 207 203 6740 or e-mail: t.jervis@defacto.com.
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