Practical uses of HRMS for regulated bioanalysis

Your Challenge

Developing sensitive and specific bioanalytical methods for large molecule drugs and biomarkers, even when no critical reagents are available.

Low limits of quantitation as well as a high degree of specificity are necessary for accurate and precise measurement of many antibodies, Ab drug conjugates, oligonucleotides, and protein and peptide biomarkers. An additional layer of complexity can arise when no capture reagents are available, existing capture reagents are not sufficiently specific, or when triple quadrupole mass spectrometry provides insufficient mass resolution or fragmentation.

Your Solution

Leverage IQVIA Laboratories expertise to deliver low pg/mL limits of quantitation for biomarkers and biotherapeutics using high-resolution mass spectrometry (HRMS).

Our expertise with hybrid-immunoassay-LC-MS, as well as critical-reagent free methodologies under both fit-for-purpose and ICH M10 compliant standards, means that you can measure your endpoint faster with a high level of confidence. We have over 15 years-experience leveraging high-resolution mass spectrometry to provide highly sensitive and specific methods for large molecule targets such as antibodies and drug conjugates, oligonucleotides, and protein and peptide biomarkers.

High-resolution mass spectrometry coupled to nano-flow liquid chromatography has been used at IQVIA Laboratories to analyze over 500,000 study samples for challenging targets such as Tumor Necrosis Factor-like ligand 1A (TL1A) and Beta-Nerve Growth Factor (b-NGF).

The expert team at IQVIA Laboratories can apply these techniques to modern biotherapeutic modalities, as well where sensitivity may be limited using immunoassay alone. A hybrid immunoassay, nano-flow liquid chromatography high-resolution mass spectrometry method was developed for a bispecific antibody as the immunoassay platform could not achieve the sensitivity needed for pharmacokinetic characterization. The method developed by IQVIA Laboratories was able to achieve a lower limit of quantitation of 50 pg/mL, 60 times more sensitive than immunoassay alone.

Pharmacokinetic characterization of the bispecific antibody using immunoassay coupled to high-resolution mass spectrometry. The sensitivity via immunoassay alone was insufficient for proper characterization.

Quality control sample statistics from 3 accuracy and precision runs from the bispecific antibody method validation. Calibration curve from one accuracy and precision run shown.

50 pg/mL lower of limit of quantitation for the bispecific antibody acquired by a triple quadrupole mass spectrometer (left) and high-resolution mass spectrometer (right).

Talk to an expert

Leverage our expertise and standard operating procedures to help support your studies including hybrid-immunoassay-LC-MS and critical reagent free methods for antibodies and Ab drug conjugates, oligonucleotides, and protein and peptide biomarkers.

Reach out to us today.