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Monoclonal Antibodies
There are many complex issues to consider in the development, testing and manufacture of monoclonal antibodies by biotechnology and pharmaceutical companies. The versatility of monoclonal antibodies as therapeutics, diagnostics and as reagents in drug discovery research poses numerous challenges to their developers. Such products must be well characterized, with all raw materials and cell banks extensively tested for adventitious agents. Process validation (especially for viral clearance) is also of paramount importance.

Covance Biotechnology Services offers protein- and immunochemistry services to characterize hybridomas and to assess the specificity, potency and isotype of the monoclonal antibodies they secrete. Our immunochemists are experts possessing many years of experience in testing and characterizing such biotherapeutics.

The Department of Histology at Covance Harrogate carries out tissue cross-reactivity studies on monoclonal antibodies. The facility is fully accredited on the UK MCA Regulatory Compliance Program and works extensively with regulatory authorities worldwide.

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