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Insight

Challenges in Method Development and Validation of LC-MS Biomarker Assays
Home / Insights / Challenges in Method Development and Validation of LC-MS Biomarker Assays

Download this presentation to learn more about challenges in method development and validation of LCMS biomarker assays, including endogenous presence of the analytes in the biological matrix as well as the disparity between the reference material used to create spiked calibrators and the endogenous form of the target biomarker. 

We are one of the few bioanalytical laboratories successfully employing immunoprecipitation techniques and multi-dimensional LC for the quantitation of biotherapeutics, peptides, proteins, and biomarkers. The IQVIA Laboratories team has the experience and knowledge in biomarker assay development and validation of small and mid-size peptides to proteins, fusion proteins and monoclonal antibodies. The development of these assays is followed by method validation and sample analysis consistent with global regulatory requirements and governed by SOPs.

Author:
Barry Jones, Ph.D, Associate Director, LCMS Biologics and Biomarkers