GMP Certification Extended for Cobra Biologics

Feb 11, 2014

Cobra Biologics, an international CMO of biologics andpharmaceuticals, reported that its GMP Compliance Certification has been extended to include QC testing and release of customers’ registered products for in-market supply.

Following an inspection at the company’s center of excellence for mammalian antibody and recombinant protein production in Södertälje, Sweden, the the Läkemedelsverket (Medical Products Agency) has considered that the facility complies with the principles and guidelines of GMP in the Commission Directive 2003/94/EC for Human Medicinal, and Investigational Medicinal, Products.

This improved certification for biological medicinal products includes 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 the QC testing of registered products.

Source: Cobra Biologics