Mar 23, 2021 – MSDG Meeting

Abstract: Monoclonal antibodies (mAbs) have become the most common modality for Biopharma therapeutic research programs. Years of research and development are required to identify the best candidate to move forward into clinical trials. Along the way, many analytical assays are used to screen, characterize and quantify these biomolecules. Traditionally, immunoassays such as ELISA (enzyme-linked Immunosorbent assay) have been the preferred analytical method, but more techniques have been stepping up to the challenge. Since the unique critical reagents required for ELISA can take months to generate, analytical techniques that take less method development time can have an “early-adoption” advantage that speeds up critical decision-making. Among them, LC-MS is the most appealing due to the accuracy, sensitivity, and specificity achieved by it.

In this presentation, we will discuss workflows to aid in the development, characterization and quantitation monoclonal antibodies. Shimadzu’s Cell Culture Media analysis provides bioprocess development scientists a 125-component snapshot in a single 17-minute LCMSMS method. Coupled with Protein Metrics Byos software, Shimadzu’s 9030 LCMS-QToF can provide an in-depth assessment of a mAb’s overall composition. Finally, Shimadzu’s nSMOL immunocapture kit for the quantitation of traditional mAbs, biosimilars, and hybrids by LC-MS/MS. Along with the nSMOL kit, the Ultra Fast scanning (30000 u/sec) and extreme sensitivity of the Shimadzu LCMS-8060 system allows for the detection of many CDR peptides from a single mAb or even for multiplexed samples in a single analytical run. The minimal method development time of nSMOL coupled with mass spectrometry can be a game-changer for mAb analysis in a high-throughput laboratory.