Featured Services & Capabilities
Covance BioPharmaceutical CMC Solutions offers comprehensive and integrated CMC development services for both small and large molecules. Our small molecule capabilities are offered in Harrogate, UK and Greenfield, Indiana, US. Our small molecule capabilities are offered in Porcheville, France, Alnwick and Harrogate, UK.
Covance large-molecule BioPharmaceutical CMC Solutions include protein chemistry, bioassay studies, immunocharacterization, biosafety testing, viral clearance, stability and release, and molecular biology.
We successfully support the development of more than 250 biomolecules each year, including monoclonal antibodies, recombinant proteins, cytokines, hormones, vaccines, gene therapy products and biosimilars. Our industry leading protein chemistry and bioassay expertise enables us to develop and optimize methods for clients and perform all essential testing to release a biologic product.
Covance small-molecule BioPharmaceutical CMC Solutions include API development, characterization and supply, preformulation studies including polymorph and salt screening, formulation development, CMC regulatory documentation services and analytical development, including method development and stability and release testing.
In addition, we provide unique specialty capabilities, including physical properties characterization, inhalation drug product testing, extractables and leachables evaluation, impurity analysis, and GMP analysis of radiolabeled clinical trial material (CTM) for human AME studies, and QP release in Europe.
Covance BioPharmaceutical CMC Solutions are built on global GMP quality systems, industry-leading scientific expertise, purpose-built facilities, centers of excellence, and decades of excellent client service experience. Our proven experience and expertise has helped biopharmaceutical companies reduce the time to development milestones, improve molecule hit rate and increase the likelihood of regulatory approval on the first pass.