For 40 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, such as pediatric, elderly, ethnic, renal and hepatic insufficiency patients and post-menopausal women. The team 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, which are supported by Watson LIMS and Labnotes electronic laboratory notebook data and documentation systems, tested to European and North American systems validation criteria.
With more than 25 years’ experience in immunogenicity testing, Celerion’s experience with a wide variety of products, including therapeutic proteins (pegylated or nonpegylated), peptides and antibodies, is unparalleled. Full GLP-certified immunoassay capabilities, using ELISA, RIA, electrochemiluminescence (ECLA), Western blot, and other technologies, is provided.
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 clients to determine appropriate dose ranges and associated therapeutic effects for new drug products in many therapeutic classes.
The team’s cross-functional experience in both small and large molecule analysis translates to faster turnaround times developing and validating the right assay to meet clinical and regulatory requirements.
The facilities are GLP certified by Swissmedic and ANVISA, also supported by regulatory bodies throughout the OECD. The OECD Principles of Good Laboratory Practice are accepted by regulatory authorities throughout the European Union, United States of America and Japan. Celerion has implemented the FDA and EMA guidelines for bioanalytical method validation and sample analysis.