Quantitative Measurement of a Candidate Antibody Therapeutic in Human Plasma

Demonstration that a 2% formic acid digestion can produce a selective signature peptide for antibody quantification using nano-LC/MS/MS

Presented at the 2016 American Society for Mass Spectroscopy Sanibel Conference, this presentation highlights the Q2 Solutions team’s efforts in providing a tailored method for a challenging biotherapeutic drug compound.  The Q2 Solutions team was tasked with developing 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 Q2 Solutions team was able to obtain good assay statistics, including inter-individual selectivity and accuracy.

Q2 Solutions 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.

Lian Shan, Robert M. Sturm, Raymond F. Biondolillo, John E. Buckholz, Barry R. Jones, John R. Perkins, Ryan Faucette and Daniel J. Sexton

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