Page 28 - Shimadzu Journal vol.9 Issue2

Biopharmaceutical

Uncovering the Clinical Significance of

Trough Levels of Antibody Therapeutics

*
Using nSMOL Assay in Cancer Immunotherapy

Noriko Iwamoto , Takashi Shimada 1
1
1 SHIMADZU Bioscience Research Partnership (SBRP), Shimadzu Scientific Instruments
* For Research Use Only. Not for use in diagnostic procedures.

In 1986, the first monoclonal antibody (mAb) was approved by the Previously, we developed the universal method for mAbs quan-
United States Food and Drug Administration (US FDA). Supported tification, nano-surface and molecular-orientation limited (nSMOL)
by rapid advances in antibody engineering, the number of ap- proteolysis, as an analytical platform for LC-MS from biological
proved mAbs reached 100 in April 2021, and more than 900 mAbs samples . Most of the therapeutic mAbs are immunoglobulin Gs
1
are currently in clinical trials. With such a dramatic increase of (IgGs). nSMOL principle is based on Fab-selective proteolysis of
mAbs and their use in various treatments, there is a need for assay IgGs using antibody capturing Protein A beads and trypsin-immo-
technology that can obtain the accurate kinetics and concentration bilized on the surface of nanoparticles (Fig. 1). IgGs captured in
of any mAbs in serum/plasma. 100 nm of Protein A pores are oriented Fab region to the reaction

Fig. 1. Conceptual diagram of the pretreatment method nSMOL Antibody BA kit for antibody quantification using LCMS

Shimadzu Journal vol.9 Issue2 61