Expertise in Immunogenicity Assessment


Assessment of bio-therapeutic and vaccine immunogenicity

Experience and Expertise

Celerion has over 30 years’ experience in immunogenicity assessment using various immunoanalytical and cell-based technologies. You can rely on our experience and capabilities—Celerion developed and validated its first two human anti-human antibody methods at the inception of immunogenicity testing in the mid-1990s.

Immunogenicity work is performed at both our facilities in Lincoln, Nebraska and Zürich, Switzerland. The team is renowned for their expertise in multi-tier immunogenicity assays such as screening, confirmatory, cell-based and non-cell-based neutralizing antibody assays on multiple platforms and matrices. Celerion's scientists also have experience and expertise in the development and validation of specialized immunogenicity assays to support vaccine development.

 


Breadth of Technology

ELISA, RIA, AlphaLISA and Electrochemiluminescence (ECLA) are critical for the assessment of immunogenicity. Celerion's Bioanalytical Sciences offers cutting edge technologies such as Flow Cytometry, and ELISpot for the assessment of cellular immunogenicity. Celerion also utilizes cell-based assays with various end point assessment for the measurement of neutralizing antibody assays. Our wide variety of technology platforms allows us to choose the right technology for your molecule.

Celerion has developed and validated immunogenicity methods for the analysis of diverse biotherapeutics such as pegylated and non-pegylated therapeutic proteins, peptides, antibodies (intact fragments, single chain, fusion-protein and peptides), biosimilar antibody drug conjugates and vaccines. The team’s experience with a wide variety of products and technology platforms, is unparalleled.

 


We also have the capabilities to develop anti-drug antibody assays using immunocapture mass spectrometry methods. We provide optimized workflow with immunoaffinity sample clean-up, optimized trypsin digestion, and LC-MS/MS detection. While chromatography methods are new for the detection of anti-drug antibodies (ADAs), it holds promise in measuring ADAs and simultaneously performing isotyping with minimal interference from therapeutic molecules. Celerion scientists are in the forefront of this cutting edge technology. No matter how complex the assay, our team has the scientific expertise to implement appropriate immunogenicity assays using the latest technologies and to ensure delivery of quality results on time.

Discerned Immunogenicity Assessment of a Recombinant Glycoprotein Containing Nonhuman Sialic Acid Neu5Gc Residues

Discover the method established for discerned immunogenicity assessment of a recombinant glycoprotein containing nonhuman sialic acid Neu5Gc residues

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