Bioanalytical method development is the critical step in the biopharmaceutical pipeline as it bridges the transition to pre-clinical and clinical phases. Ligand-binding assay (LBA) has been the common technique for biologics, however, LC-MS is emerging as an alternative to reduce time and cost needed for method development and to gain increased selectivity and efficiency. To further simplify and streamline the LCMS workflow for antibody bioanalysis, Shimadzu developed an innovative nanotechnologybased nSMOLâ„¢ Antibody Bioanalysis platform for the selective proteolysis of the Fab region of antibody drugs. This increases the detection sensitivity of surrogate peptides in CDR regions, which can be accurately quantified via MRM measurements using a triple quadrupole high performance liquid chromatograph mass spectrometer.

Accelerating the pre-clinical/clinical phase