Analysis of Large Molecule Drugs and Biomarkers
Large molecule work is performed at both our facilities in Lincoln, Nebraska and Zürich, Switzerland. Celerion’s facility in Zürich is one of the largest ligand binding laboratories in the world with more than 25 years’ experience in immunogenicity testing. The team, consisting of over 70 scientists, is renowned for their expertise in immunogenicity testing and has extensive experience in immunoassay capabilities, including method development, validation and production sample analysis for all immunoanalytical technologies.
Immunoanalytical techniques such as ELISA, RIA and Electrochemiluminescence (ECLA) are critical for the analysis of large protein molecules and antibody drugs, as well as biosimilars and biomarkers.
Celerion has developed and validated immunoassay and immunogenicity methods for the analysis of pegylated and non-pegylated therapeutic proteins, peptides, antibodies (intact fragments, single chain, fusion-protein and peptides) and oligonucleotides. The team’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, ECLA, Western blot, and other technologies is provided.
Celerion is expanding the services currently offered with further investments in Luminex technology to enable access to a broad variety of biomarker of effect assays. Panel assays are currently offered at the Zurich facility and based on client demand, coupled with the growth of assays validated to magnetic beads, this powerful technology will be available soon in the Lincoln, Nebraska USA facility.
The list of key pharmacodynamic biomarkers is continually updated, with a recent focus on enhancing diabetes biomarker offerings, including methods for ghrelin, adiponectin, GLP-1, glucagon, c-peptide, IGF-1 and IGFBP-3.
Celerion has the capacity and expertise to help clients achieve their large molecule study timelines.