Covance Expands UK Facility, Receives MHRA License for Cell Banking

Covance Inc. (Princeton, NJ) has completed an additional 8,000-sq. ft. to its biotechnology services facility in Harrogate, UK. The expanded facility includes new Class 10,000 laboratories and equipment for biopotency, molecular biology, and protein chemistry services.

The expansion enables the company to offer new services, such as cGMP DNA sequencing, and viral clearance, PCR-based mycoplasma, and sterility testing. The company also has tripled the capacity of its molecular biology, safety testing, and bioassay service lines, and introduced a purpose-designed mycoplasma testing facility separation from the main operational areas.

The Harrogate site also recently received a current good manufacturing practice (cGMP) manufacturing license from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for the manufacture of master cell banks and working cell banks. Following a recent change in policy, the MHRA now requires a cGMP license for cell banking because it considers this activity to be the starting point of the manufacturing process. As part of the license, a Qualified Person now formally releases the manufactured cell bank as part of the review and verification processes.