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

Bioanalysis

Volumn 5, Issue 11, 2013, Pages 1363-1376

  Furlong, Michael T ^a   Zhao, Song ^b   Mylott, William ^b   Jenkins, Rand ^b   Gao, Mian ^a   Hegde, Vendana ^a   Tamura, James ^a   Tymiak, Adrienne ^a   Jemal, Mohammed ^c  

^a BRISTOL MYERS SQUIBB   (United States)

^b Pharmaceutical Product Development   (United States)

^c Protein Science and Structure ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ASPARAGINE; IMMUNOGLOBULIN G1; IMMUNOGLOBULIN G4; IMMUNOGLOBULIN HEAVY CHAIN; IMMUNOGLOBULIN KAPPA CHAIN; IMMUNOGLOBULIN LIGHT CHAIN; MONOCLONAL ANTIBODY;

ACCURACY; AMINO ACID SEQUENCE; ANIMAL EXPERIMENT; ARTICLE; CALIBRATION; DEAMINATION; DRUG BLOOD LEVEL; DRUG DETERMINATION; DUAL UNIVERSAL PEPTIDE ASSAY; HAPLORHINI; ISOTOPE LABELING; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; NONHUMAN; SENSITIVITY AND SPECIFICITY;

EID: 84878836623     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.55     Document Type: Article

References (20)

1. Beck A, Wagner-Rousset E, Bussat M-C et al. Trends in glycosylation, glycoanalysis and glycoengineering of therapeutic antibodies and Fc-fusion proteins. Curr. Pharm. Biotechnol. 9(6), 482-501 (2008
2. Strohl WR. Therapeutic monoclonal antibodies: Past, present, and future. In: Therapeutic Monoclonal Antibodies: From Bench to Clinic. John Wiley, Hoboken, NJ, USA, 3-50 (2009
3. Beck A, Wurch T, Bailly C, Corvaia N. Strategies and challenges for the next generation of therapeutic antibodies. Nat. Rev. Immunol. 10(5), 345-352 (2010
4. Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat. Rev. Drug Discov. 9(10), 767-774 (2010
5. Halquist MS, Thomas Karnes H. Quantitative liquid chromatography tandem mass spectrometry analysis of macromolecules using signature peptides in biological fluids. Biomed. Chromatogr. 25(1-2), 47-58 (2011
6. Ezan E, Bitsch F. Critical comparison of MS and immunoassays for the bioanalysis of therapeutic antibodies. Bioanalysis 1(8), 1375-1388 (2009
7. Furlong MT, Ouyang Z, Wu S et al. A universal surrogate peptide to enable LC-MS/MS bioanalysis of a diversity of human monoclonal antibody and human Fc-fusion protein drug candidates in pre-clinical animal studies. Biomed. Chromatogr. 26(8), 1024-1032 (2012
8. Ouyang Z, Furlong MT, Wu S et al. Pellet digestion: A simple and efficient sample preparation technique for LC-MS/MS quantification of large therapeutic proteins in plasma. Bioanalysis 4(1), 17-28 (2012
9. Bronsema KJ, Bischoff R, van de Merbel NC. Internal standards in the quantitative determination of protein biopharmaceuticals using liquid chromatography coupled to mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 893-894, 1-14 (2012
10. Pritchard C, Quaglia M, Ashcroft AE, O'Connor G. Considering the advantages and pitfalls of the use of isotopically labeled protein standards for accurate protein quantification. Bioanalysis 3(24), 2797-2802 (2011
11. Jemal M. Universal Surrogate Peptide Concept and Other Recent Insights in Therapeutic Protein Quantitative Bioanalysis by LC-MS/MS. Delaware Valley Drug Metabolism Discussion Group, DE, USA (2012
12. Li H, Ortiz R, Tran L et al. General LC-MS/MS method approach to quantify therapeutic monoclonal antibodies using a common whole antibody internal standard with application to preclinical studies. Anal. Chem. 84(3), 1267-1273 (2012
13. Viswanathan CT, Bansal S, Booth B et al. Quantitative bioanalytical methods validation and implementation: Best practices for chromatographic and ligand binding assays. Pharm. Res. 24(10), 1962-1973 (2007
14. Fast DM, Kelley M, Viswanathan CT et al. Workshop report and follow-up -AAPS Workshop on current topics in GLP bioanalysis: Assay reproducibility for incurred samples -implications of Crystal City recommendations. AAPS J. 11(2), 238-241 (2009
15. Geiger T, Clarke S. Deamidation, isomerization, and racemization at asparaginyl and aspartyl residues in peptides. Succinimide-linked reactions that contribute to protein degradation. J. Biol. Chem. 262(2), 785-794 (1987
16. Patel K, Borchardt RT. Chemical pathways of peptide degradation. II. Kinetics of deamidation of an asparaginyl residue in a model hexapeptide. Pharm. Res. 7(7), 703-711 (1990
17. Yan B, Steen S, Hambly D et al. Succinimide formation at Asn 55 in the complementarity determining region of a recombinant monoclonal antibody IgG1 heavy chain. J. Pharm. Sci. 98(10), 3509-3521 (2009
18. Yang H, Zubarev RA. Mass spectrometric analysis of asparagine deamidation and aspartate isomerization in polypeptides. Electrophoresis 31(11), 1764-1772 (2010
19. Ren D, Pipes GD, Liu D et al. An improved trypsin digestion method minimizes digestion-induced modifications on proteins. Anal. Biochem. 392(1), 12-21 (2009
20. Jemal M, Xia YQ. Bioanalytical method validation design for the simultaneous quantitation of analytes that may undergo interconversion during analysis. J. Pharm. Biomed. Anal. 22(5), 813-827 (2000