Bioanalytical Services

For over 30 years, Celerion has delivered timely and robust bioanalytical data from the analysis of small and large molecules from every phase of drug development.

Studies have required the analysis of drugs, metabolites and biomarkers in a broad range of biological fluids and tissues from numerous species. Celerion has supported research and regulated toxicokinetic studies, as well as clinical pharmacokinetic and pharmacodynamic protocols, including ascending dose, drug-drug interaction, food effect, and market image bioequivalence study designs.

Celerion’s bioanalytical expertise includes support of special population studies in pediatric, elderly, ethnic, renal and hepatic insufficiency patients and post-menopausal women. The company excels at supporting long duration phase II and III studies, particularly multi-site patient and population pharmacokinetic studies.

Celerion uses state of the art LC-MS/MS, immunoanalytical and immunogenicity instrumentation supported by Watson LIMS and Labnotes electronic laboratory notebook data and documentation systems that have been carefully tested to North American and European systems validation criteria.

The biomarker capabilities at Celerion are also facilitated by LC-MS/MS and immunoanalytical techniques. Recent efforts have produced excellent results for a range of methods focused on pain management, diabetes and inflammation. Immunoanalytical methods are validated to CLIA/CAP or GLP guidelines, depending on whether pharmacodynamic or pharmacokinetic data is required to achieve study goals. Key methods have been developed for peptides, nucleotides and a range of oligomeric analytes. Support of drug, metabolite and biomarker analysis allows Celerion’s clients to determine appropriate dose ranges and associated therapeutic effects for new drug products in many therapeutic classes.

Celerion constantly strives to deliver customized, reliable and efficient bioanalytical services that keep clients’ projects on track during all phases of development. Celerion’s attention to regulatory guidelines in European (e.g. Swissmedic, EMA), North American (e.g. FDA, HealthCanada), South American (e.g. ANVISA) and Asian (e.g. MHLW) geographies supports filing of reliable bioanalytical data with any global regulatory agency.

Celerion is focused on meeting timelines at a price appropriate to the client’s drug development budget.