Pre-clinical / clinical phase
Shimadzu Pre-clinical / clinical phase
Bioanalytical method development is a crucial phase in the biopharmaceutical pipeline, facilitating the transition to preclinical and clinical stages. While ligand-binding assays (LBAs) have been the standard technique for biologics, liquid chromatography-mass spectrometry (LC-MS) is gaining traction as a more efficient and cost-effective alternative. To enhance the LC-MS workflow for antibody bioanalysis, Shimadzu has introduced the innovative nSMOL™ Antibody Bioanalysis platform. This nanotechnology-based solution enables selective proteolysis of the Fab region of antibody drugs, significantly improving the detection sensitivity of surrogate peptides in complementarity-determining regions (CDRs). These peptides can be accurately quantified using multiple reaction monitoring (MRM) with a triple quadrupole high-performance liquid chromatography-mass spectrometer, streamlining the bioanalytical process.