An exploratory universal LC-MS/MS assay for bioanalysis of hinge region-stabilized human IgG4 mAbs in clinical studies

Bioanalysis

Volumn 6, Issue 13, 2014, Pages 1747-1758

  Furlong, Michael T ^a,b   Titsch, Craig ^a   Xu, Weifeng ^a   Jiang, Hao ^a   Jemal, Mohammed ^b   Zeng, Jianing ^a  

^a BRISTOL MYERS SQUIBB   (United States)

^b Molecular and Bioanalytical Pharmacology Amicus Therapeutics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMINO ACID; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY IGG4; PEPTIDE; UNCLASSIFIED DRUG; IMMUNOGLOBULIN G; IMMUNOGLOBULIN HEAVY CHAIN; TRYPSIN;

AMINO ACID SUBSTITUTION; ARTICLE; BINDING AFFINITY; CLINICAL STUDY; DRUG DETERMINATION; DRUG RESEARCH; DRUG STABILITY; HAPLORHINI; HINGE REGION; HUMAN; LIGAND BINDING; LIQUID CHROMATOGRAPHY; MEASUREMENT ACCURACY; NONHUMAN; SENSITIVITY ANALYSIS; TANDEM MASS SPECTROMETRY; VALIDATION PROCESS; AMINO ACID SEQUENCE; BLOOD; CALIBRATION; CHEMISTRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; METABOLISM; MOLECULAR GENETICS; PROTEIN TERTIARY STRUCTURE; STANDARDS;

AMINO ACID SEQUENCE; AMINO ACID SUBSTITUTION; ANTIBODIES, MONOCLONAL; CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HUMANS; IMMUNOGLOBULIN G; IMMUNOGLOBULIN HEAVY CHAINS; MOLECULAR SEQUENCE DATA; PEPTIDES; PROTEIN STRUCTURE, TERTIARY; TANDEM MASS SPECTROMETRY; TRYPSIN;

EID: 84906670900     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.14.64     Document Type: Article

References (22)

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. An Z (Ed.). John Wiley &Sons, Inc., 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. Furlong MT, Zhao S, Mylott W et al. Dual universal peptide approach to bioanalysis of human monoclonal antibody protein drug candidates in animal studies. Bioanalysis 5(11), 1363-1376 (2013).
10. Immunogenetics Information System www.imgt.org
11. ExPASy. Bioinformatics Resource Portal. www.expasy.org
12. Kabat E, Wu TT, Reid-Miller M, Perry HM, Gottesman KS. Sequences of Proteins of Immunological Interest. United States Department of Health and Human Services, Washington DC, USA (1987).
13. Jiang H, Zeng J, Titsch C et al. Fully validated LC-MS/MS assay for the simultaneous quantitation of coadministered therapeutic antibodies in cynomolgus monkey serum. Anal. Chem. 85(20), 9859-9867 (2013).
14. King DJ, Adair JR, Angal S et al. Expression, purification and characterization of a mouse-human chimeric antibody and chimeric Fab fragment. Biochem. J. 281(2), 317-323 (1992).
15. Deng L, Wylie D, Tsao Yung S et al. Detection and quantification of the human IgG4 half-molecule, HL, from unpurified cell-culture supernatants. Biotechnol. Appl. Biochem. 40(Pt 3), 261-269 (2004).
16. Labrijn AF, Buijsse AO, van den Bremer ETJ et al. Therapeutic IgG4 antibodies engage in Fab-arm exchange with endogenous human IgG4 in vivo. Nat. Biotechnol. 27(8), 767-771 (2009).
17. Stubenrauch K, Wessels U, Regula JT, Kettenberger H, Schleypen J, Kohnert U. Impact of molecular processing in the hinge region of therapeutic IgG4 antibodies on disposition profiles in cynomolgus monkeys. Drug Metab. Dispos. 38(1), 84-91 (2010).
18. Angal S, King DJ, Bodmer MW et al. A single amino acid substitution abolishes the heterogeneity of chimeric mouse/ human (IgG4) antibody. Mol. Immunol. 30(1), 105-108 (1993).
19. 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).
20. White JT, Golob M, Sailstad J. Understanding and mitigating impact of immunogenicity on pharmacokinetic assays. Bioanalysis 3(16), 1799-1803 (2011).
21. Kelley M, Ahene AB, Gorovits B et al. Theoretical considerations and practical approaches to address the effect of anti-drug antibody (ada) on quantification of biotherapeutics in circulation. AAPS J. 15(3), 646-658 (2013).
22. Wang SJ, Wu ST, Gokemeijer J et al. Attribution of the discrepancy between ELISA and LC-MS/MS assay results of a PEGylated scaffold protein in post-dose monkey plasma samples due to the presence of anti-drug antibodies. Anal. Bioanal. Chem. 402(3), 1229-1239 (2012).