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12th European Biosimilars Congress

Geneva, UK

Jane Xiao

Jane Xiao

Axcel BioPartners, USA

Title: Biosimilar assessment: Quantitation of antibody variants and pharmacokinetic studies using peptide mapping LC-MS analysis


Biography: Jane Xiao


Introduction: Peptide mapping has been widely accepted as an identity test for biotherapeutics in the QC lab. Recently, the peptide mapping based-multi attribute method (MAM) by ultrahigh performance liquid chromatography (UPLC) coupled to high resolution mass spectrometry (HRMS) have been employed for the confirmation of sequence, and the identification and quantitation of sequence variants and modifications for biosimilar development directly and simultaneously. In addition the peptide mapping technique combining multiple reaction monitoring (MRM) HRMS is gaining momentum as an alternative tool in the pharmacokinetic studies of large molecules including biosimilars. However, one common challenge for application of the technique is sample preparation due to specific structural complex and/or biological endogenous interference. The purpose of this presentation is to describe the approaches of optimization of sample preparation in peptide mapping for quantitation of antibody variants and for pharmacokinetic studies.

Recent Publications

  1. Marini J C, et al. (2014) White paper: systematic verification of bioanalytical similarity between a biosimilar and a reference biotherapeutics. AAPS Journal 16(6):1149-1158.
  1. Islam R (2014) Bioanalytical challenges of biosimilars. Bioanalysis 6(3):349-356.
  1. Iwamoto N, et al. (2016) Validated LC/MS bioanalysis of Rituximab CDR peptides using nanosurface and molecular-orientation limited (nSMOL) proteolysis. Biol. Pharm. Bull. 39(7):1187-1194.
  1. Baru R (2017) Applications of targeted proteomics and mass spectrometry in Trastuzumab pharmacokinetics assessments. J Syst Biol Proteome Res 1(1):7-9.
  1. Vialaret J, et al. (2018) What sample preparation should be chosen for targeted MS monoclonal antibody quantification in human serum? Bioanalysis 10(10):723-735.

Conclusion: Platform peptide map MAM LC-MS method works for mAbs. Some mAbs are susceptible to oxidation formation at methionine residues. For accurate oxidation measurement, the use of isotope labelled peptide map LC-MS is essential.