Key Strategies for Large Molecule Bioanalysis
No matter how complex, our team has the scientific expertise to analyze large molecules using the latest technologies and to ensure delivery of quality results on time. Celerion has over 30 years’ experience in large molecule bioanalysis including method development, validation and sample analysis for all immunoanalytical technologies. You can rely on our experience and capabilities—we developed and validated our first two human anti-human antibody methods at the inception of immunogenicity testing in the mid-1990s.
Large molecule work is performed at both our facilities in Zürich, Switzerland and Lincoln, Nebraska. The team, consisting of over 80 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 immuno-analytical technologies.
We use immunoanalytical techniques such as ELISA, RIA, AlphaLISA and Electrochemiluminescence (ECLA) which are critical for the analysis of large protein molecules and antibody drugs, including biosimilars. In addition, Celerion’s Bioanalytical Sciences also offers state-of-the-art technologies such as Flow Cytometry, qPCR and ELISpot assays in a highly regulated environment to support preclinical and clinical studies.
We have 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. Our team’s experience with a wide variety of products, including therapeutic proteins (pegylated or nonpegylated), peptides, antibodies, and nucleic acid is unparalleled. Full GLP-certified immunoassay capabilities, using ELISA, RIA, AlphaLISA, ECLA, Western blot, and other technologies, is provided.
What’s more, our large molecule expertise includes development and validation of multi-tier immunogenicity assays such as screening, confirmatory, cell-based and non-cell-based neutralizing antibody assays on multiple platforms and matrices. Our wide variety of technology platforms allows us to choose the right technology for your molecule.
We have the capabilities to develop protein quantitation assays using mass spectrometry including off-the-shelf assays for the quantitation of humanized monoclonal antibodies in preclinical samples without waiting for immunoassay reagents. We also provide optimized workflow with immunoaffinity sample clean-up, optimized trypsin digestion, and LC-MS/MS detection.
Innovative Bioanalytical Tools for Validating in a Regulatory Compliant Manner.
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