Dual universal peptide approach to bioanalysis of human monoclonal antibody protein drug candidates in animal studies

作者：Furlong Michael T^*; Zhao Song; Mylott William; Jenkins Rand; Gao Mian; Hegde Vendana; Tamura James; Tymiak Adrienne; Jemal Mohammed

来源：Bioanalysis, 2013, 5(11): 1363-1376.

DOI：10.4155/BIO.13.55

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. Conclusion: Improvements reported herein to the universal peptide assay will enable more reliable quantification of human monoclonal antibody protein drug candidates in animal studies.

• 出版日期2013-6