Cobra Biologics Extends GMP Certification
In December 2013, business growth necessitated CMO Cobra Biologics install a new Thermo Scientific 1000L HyClone Single-Use Bioreactor (SUB) at the company’s centre of excellence for mammalian antibody and recombinant protein production. In announcing the expansion, the company cited a ten-fold increase in antibody business over the prior two years, growth in contract manufacturing services, and its continued commitment to single-use disposable technologies.
Cobra started its expansion in 2011 with the acquisition with the building of an aseptic manufacturing facility designed to provide fill and finish services for pre-filled syringes, vials and freeze drying/lyophilisation. At the time, company CEO Peter Coleman noted the move marked a continuation of its strategy for sustained growth. “Demand is such that we have the confidence to invest for the future and we see this as just a stepping stone in the expansion of our capabilities at all three Cobra facilities,” he said.
That same Centre of Excellence has now extended its GMP Compliance Certification to include Quality Control (QC) testing and release of customers’ registered products for in-market supply. This announcement follows an inspection by the Läkemedelsverket (Medical Products Agency), which concluded 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 now encompasses:
- manufacturing of active substances by culture of mammalian cells
- storage of both mammalian and microbial cell banks
- release testing of protein for clinical trials
- quality control testing of registered products.
“Quality Control testing of registered products is a very important step for Cobra in becoming a recognised commercial supplier of antibodies and recombinant proteins,” notes Coleman. “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.”