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Insight

Bottom-Up Quantitative Measurement of a Candidate Antibody Therapeutic in Human Plasma by LC-MS/MS using Formic Acid Digestion
Home / Insights / Bottom-Up Quantitative Measurement of a Candidate Antibody Therapeutic in Human Plasma by LC-MS/MS using Formic Acid Digestion

Presented at the 2016 American Society for Mass Spectroscopy Sanibel Conference, this presentation highlights how IQVIA Laboratories developed a liquid chromatography with tandem mass spectrometry (LC-MS/MS) assay for quantification of a candidate antibody therapeutic in human plasma. Using formic acid digestion, the IQVIA Laboratories team obtained good assay statistics, including inter-individual selectivity and accuracy.

IQVIA Laboratories is one of the few bioanalytical laboratories successfully employing immunoprecipitation techniques and multi-dimensional LC for the quantitation of biotherapeutics, peptides, proteins, and biomarkers. Our team has the experience and knowledge in 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.

Download the presentation to learn more about LC-MS/MS method development at IQVIA Laboratories.

Authors:
Jack Henion, Ph.D., Vice President, R&D
Barry Jones, Ph.D., Associate Director, LCMS Biologics and Biomarkers