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Laboratory Profile: Covance Laboratory

Covance Laboratory Services :

*Genetic Toxicology Services: -GLP and screening in vitro genetic toxicology studies. -S.typhimurium, E. coli, TK6, L5178Y, human lymphocytes. -Gene mutation, in vitro cytogenetics. -Other in vitro services: Phototoxicity, LLNA replacements, FETAX (Frog Embryo Teratogenesis Assay Xenopus).

*General Toxicology Services: -Standard/non standard GLP studies. -Species : Rodents, Rabbit, Canine. -Acute to chronic administration through several routes of administration (oral, intravenous, intramuscular, intraperitoneal, subcutaneous, intranasal). Integrated Pathology Services.

*Histology: -Clinical Pathology. -Histopathology evaluation by Certified Veterinary Pathologists. -GLP electronic microscopy.

*Chemistry, Manufacturing & Control solutions for small molecules (PharmCMC): -API process development, process safety, crystallization, route scouting & troubleshooting. -API manufacture and supply for preclinical, phase I and phase II studie. -API characterization and pre-formulation (salt/co-crystal and polymorph screening). -API Analytical method development, validation and release testing. Specifically in the CMC area, Covance is a leader in: analytical chemistry, protein chemistry, cGMP stability and release of API and drug products of all dosage forms, method development and validation, structure elucidation, impurity identification, extractables and leachables, comparator testing, cGMP cell banking, biosafety testing, bioassays, viral clearance studies, PCR screening, manufacturing support.

ZI de Limay Porcheville

Porcheville, 78440 FR