Accelerating the pre-clinical/clinical phase

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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 nSMOL™ 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.

nSMOL workflow

 
 
 
 
 
 

 

nSMOL Antibody BA Kit

Simplifying workflows and enhancing sensitivity

 
  nSMOL + LCMS LBA
Ab for collection/detection Not needed 6++ months to develop
Cross reactivity test Not needed Mandatory and tricky
Pre-validation 1-3 days 2-3 weeks
Full validation 3-4 w 3-4 w
Sample prep 3-5 h 2-4 h
Data features Highly selective and reliable,
wide dynamic range, easy to
multiplex, independent of
antibodies		 Highly dependent on quality of
detection Ab.

Development of LCMS bioanalysis in combination with nSMOL proteolysis is much faster, and can dramatically accelerate the total R&D period of biologics by alleviating the bottlenecks that typically occur when entering the preclinical and clinical phase.

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