Compliance certification now includes Quality Control testing
Contract manufacturing organisation 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 mammalian antibody and recombinant protein production plant in Södertälje, Sweden, the Läkemedelsverket (Medical Products Agency) said 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 said Quality Control testing of registered products is an 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 has really put in every effort to secure the additional certification,' he said.