Cobra Biologics has announced 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 recognized 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.”