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.
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.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
