Nitrosamine Impurities Affecting Drug-Drug Interaction Studies – Learn More

Bioanalytical Sciences

Science, compliance, speed for all your bioanalytical needs

Industry-Leading Bioanalytical Services

Our laboratories focus on science, compliance and speed to deliver high-quality data. Our state-of-the-art automated facilities in Zürich, Switzerland and Lincoln, Nebraska USA, are among the most respected laboratories in the industry. We apply our 40+ years of experience to exceed your bioanalytical expectations from method development and validation through rapid sample analysis supporting discovery through late stage clinical studies. Our 100+ scientists, armed with the latest bioanalytical technologies, are committed to solving your challenges with scientific excellence. We perform, on average, over a 100 method validations per year in small and large molecules as well as immunogenicity. Through continuous improvement in quality and compliance processes and systems, and investment in the latest automation technologies, Celerion has the global capacity to analyze more than 600,000 samples per year, providing industry-leading turnaround time.

Specialty Experience and Innovations

Flow cytometry capabilities are most valuable when performed in immediate proximity to where clinical conduct studies are performed. We offer sponsors the advantage of co-locating our Lincoln bioanalytical laboratory with one of our phase I clinics. Flow cytometry has many powerful and versatile features for investigating many aspects of cell biology during drug discovery and development. Our experience with flow cytometry capabilities include sorting of cells and enumeration of rare cellular subsets and analysis of these subsets relative to the distribution of phenotypic and functional subsets. We can perform this analysis in various matrices including: whole blood, primary cells, fresh or frozen PBMC (peripheral blood mononuclear cells), cell lines, and tumor-infiltrating lymphocytes (TILs).

Additionally, with more than 30 years’ experience in immunoassay testing, our work with a wide variety of products, including therapeutic proteins (pegylated or nonpegylated), peptides and antibodies, is unparalleled. We provide full GLP-certified immunoassay capabilities, using ELISA, RIA, Electrochemiluminescence (ECLA), AlphaLisa, Western blot, and other technologies.

The biomarker capabilities at Celerion are also facilitated by LC-MS/MS and immuno-analytical techniques, and have produced excellent results for a range of methods focused on pain management, diabetes and inflammation. Our immuno-analytical methods are validated to CLIA/CAP or GLP guidelines, depending on whether pharmacodynamic or pharmacokinetic data is required to achieve your study goals. Our innovative scientists have also developed unique methods for peptides, nucleotides and a range of oligomeric analytes. Our drug, metabolite and biomarker analysis allows you to determine appropriate dose ranges and associated therapeutic effects for your new drug products.

  • Celerion has 500+ off the shelf assays to support small and large molecule bioanalysis, the most comprehensive list of assays in the industry.
  • More than 50 scientists with more than 10 years of average experience and armed with state-of-the-art technologies are committed to solving your problems with scientific excellence
  • Diversity of experience in small and large molecule bioanalysis including peptides, oligonucleotides and cell therapy etc.
  • Our global SOPs and a harmonized electronic laboratory notebook system enable easy assay transfer between our bioanalytical laboratories and ensure consistent study documentation and highly-regulated quality standards.
  • Celerion has globally implemented FDA and EMA guidelines. Our Zurich facility is GLP- certified throughout the OECD (Organization for Economic Co-operation and Development).

Flow Cytometry to Support Drug Development Studies

Unlocking Value of Flow Cytometry During Drug Development: Establishment Of Whole Blood Sample Stability For Extended Analysis

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Celerion Bioanalytical Assay List

Including all assays developed and validated and those under development.

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