Danish contract manufacturing organization (CMO) was visited by the regulatory agency in May this year, following a facility upgrade, and yesterday announced it had received renewal of its good manufacturing production license for clinical and commercial manufacturing.
The site in Copenhagen “was previously approved for GMP production of materials going into clinical trials and for commercial scale by the EMA,” Chief Scientific Officer Mads Laustsen told Outsourcing-Pharma.com.
“However we have now upgraded in order to be fully US Food and Drug Administration (FDA) compliant by changing the manufacturing layout into a full unidirectional flow layout,” he continued, adding this would service a number of customers - American and European - who were approaching commercial production.
The recent upgrade increases segregation of unit operations which the company says improves flow of materials and personnel, resulting in a layout that maintains a fully unidirectional return corridor and exit airlocks.
According to Laustsen, the site houses two mammalian bioreactors - 1,000L and 2,000L - and a 2,000L microbial bioreactors, on top of 100L and 500L mammalian bioreactors for smaller batches.
US Expansion
The company has also been expanding on the other side of the pond, with the opening of its second US operations site in Berkeley, California, just last month.
The 31,000 square foot facility includes 3000L and 500L stainless steel production bioreactors for clinical biological manufacturing.