The foot-and-mouth research and manufacturing plant is one of first to receive certification to the CWA 15793:2008 standard on Laboratory Biorisk Management
The Merck Animal Health (known as MSD Animal Health outside the US and Canada) foot-and-mouth disease (FMD) research and vaccine manufacturing site in Cologne, Germany has been certified according to the new CWA 15793:2008 standard on Laboratory Biorisk Management.
This standard sets requirements for the control of risks associated with working with biological agents and toxins in laboratories and facilities.
The German Social Accident Insurance Institution for the Raw Materials and Chemical Industry (BG RCI), an industrial institution for statutory accident insurance and prevention, audited the facility in March.
The official documentation was presented to Klaus Kriebitzsch, site director of the Cologne facility, last week (21 June).
“We are extremely proud that our FMD facility here in Cologne is among the first in the world certified according to this biosafety standard that is likely to become a new norm in the international biosafety community,” said Tobias Schlapp, head of Regional Animal Health Bio-Manufacturing at Merck Animal Health.
CWA 15793:2008 has been developed by the European Committee on Standardisation (CEN) following discussions with biosafety and biosecurity experts wolrdwide, including representatives of the European and American Biological Safety Associations (EBSA and ABSA, respectively), the Asia-Pacific Biological Safety Association, the World Health Organisation (WHO) and Det Norske Veritas (DNV).
The Cologne FMD site researches, develops and produces vaccines against FMD. The facilities for antigen production, research and quality control are located in an area that is isolated from the environment (high containment, BSL3).
The site also hosts antigen banks for several countries, which can guarantee the emergency supply of FMD vaccines.