Bioanalytical workflow for novel scaffold protein-drug conjugates: quantitation of total Centyrin protein, conjugated Centyrin and free payload for Centyrin-drug conjugate in plasma and tissue samples using liquid chromatography-tandem mass spectrometry

Bioanalysis. 2018 Oct 1;10(20):1651-1665. doi: 10.4155/bio-2018-0201. Epub 2018 Oct 29.

Abstract

Aim: Alternative scaffold proteins have emerged as novel platforms for development of therapeutic applications. One such application is in protein-drug conjugates (PDCs), which are analogous to antibody-drug conjugates.

Methodology: Liquid chromatography-mass spectrometry methods for quantitation of total protein, conjugate and free payload for a PDC based on Centyrin scaffold were developed. Tryptic peptides generated from a region of the Centyrin that does not contain a conjugation site, and another that has the conjugation site with the linker-payload attached were used as surrogates of the total and conjugated Centyrin, respectively.

Conclusion: The methods were successfully applied to analysis of samples from mice to quantify the plasma and tissue concentrations. This same workflow can potentially be applied to other PDCs and site-specific antibody-drug conjugates.

Keywords: ADC; CDC; Centyrin; Centyrin–drug conjugate; LC–MS; PDC; alternative scaffold; antibody–drug conjugate; bioanalysis; conjugation; protein–drug conjugate; quantitation.

MeSH terms

  • Animals
  • Chromatography, Liquid / methods
  • Humans
  • Mice
  • Mice, Inbred BALB C
  • Peptides / blood
  • Peptides / chemistry*
  • Peptides / pharmacokinetics*
  • Pharmaceutical Preparations / blood
  • Pharmaceutical Preparations / chemistry*
  • Pharmacokinetics
  • Protein Domains
  • Tandem Mass Spectrometry / methods
  • Tenascin / blood
  • Tenascin / chemistry*
  • Tenascin / pharmacokinetics*
  • Workflow

Substances

  • Peptides
  • Pharmaceutical Preparations
  • TNC protein, human
  • Tenascin