title: Dual universal peptide approach to bioanalysis of human monoclonal antibody protein drug candidates in animal studies.
abstract: BACKGROUND
  There is a need for general and reliable LC-MS assays capable of supporting the bioanalysis of a variety of human monoclonal antibody-based therapeutic drug candidates in animal PK/TK studies.
  
  
  RESULTS
  We present herein improvements in our previously reported universal peptide approach to the bioanalysis of human monoclonal antibody protein drug candidates in animal studies. These improvements include incorporation of a second, light chain-based universal peptide into the assay, thus introducing the concept of a dual universal peptide assay; and incorporation of a universal stable isotope-labeled monoclonal antibody into the assay.
  
  
  CONCLUSIONS
  Improvements reported herein to the universal peptide assay will enable more reliable quantification of human monoclonal antibody protein drug candidates in animal studies.
authors.affiliation: Bristol-Myers Squibb, Analytical & Bioanalytical Development, Princeton, NJ 08543, USA. michael.furlong@bms.com
authors.forename: Michael T
authors.initials: MT
authors.lastname: Furlong
authors.forename: Song
authors.initials: S
authors.lastname: Zhao
authors.forename: William
authors.initials: W
authors.lastname: Mylott
authors.forename: Rand
authors.initials: R
authors.lastname: Jenkins
authors.forename: Mian
authors.initials: M
authors.lastname: Gao
authors.forename: Vendana
authors.initials: V
authors.lastname: Hegde
authors.forename: James
authors.initials: J
authors.lastname: Tamura
authors.forename: Adrienne
authors.initials: A
authors.lastname: Tymiak
authors.forename: Mohammed
authors.initials: M
authors.lastname: Jemal
mesh_terms: D000595:Amino Acid Sequence; D000818:Animals; D000911:Antibodies, Monoclonal / Q000032:analysis / Q000493:pharmacokinetics*; D002853:Chromatography, Liquid / Q000379:methods*; D000882:Haplorhini; D006801:Humans; D007553:Isotope Labeling; D008969:Molecular Sequence Data; D010455:Peptides / Q000032:analysis*; D053719:Tandem Mass Spectrometry / Q000379:methods*
chemical_list: D000911:Antibodies, Monoclonal; D010455:Peptides