The integration of ligand binding and LC-MS-based assays into bioanalytical strategies for protein analysis

Bioanalysis

Volumn 6, Issue 13, 2014, Pages 1827-1841

  Zhang, Yan J ^a   Olah, Timothy V ^a   Zeng, Jianing ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

REAGENT; LEPTIN; LIGAND; PROTEIN;

AMINO ACID SEQUENCE; BINDING AFFINITY; BLOOD SAMPLING; CELL SURFACE; COMPLEX FORMATION; ENZYME LINKED IMMUNOSORBENT ASSAY; HUMAN; LIGAND BINDING; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; PHARMACODYNAMICS; PROTEIN ANALYSIS; PROTEIN ENGINEERING; PROTEIN FUNCTION; PROTEIN PROCESSING; PROTEIN STRUCTURE; PROTEIN TARGETING; QUANTITATIVE ANALYSIS; RADIOIMMUNOASSAY; REVIEW; SENSITIVITY ANALYSIS; TANDEM MASS SPECTROMETRY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; IMMUNOAFFINITY CHROMATOGRAPHY; IMMUNOPRECIPITATION; ISOLATION AND PURIFICATION;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; ENZYME-LINKED IMMUNOSORBENT ASSAY; IMMUNOCHROMATOGRAPHY; IMMUNOPRECIPITATION; LEPTIN; LIGANDS; PROTEINS; TANDEM MASS SPECTROMETRY;

EID: 84906700062     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.14.128     Document Type: Review

References (54)

1. Wang W, Wang EQ, Balthasar JP. Monoclonal antibody pharmacokinetics and pharmacodynamics. Clin. Pharmacol. Ther. 84(5), 548-558 (2008).
2. Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat. Rev. Cancer 12(4), 278-287 (2012).
3. Yalow RS, Berson SA. Immunoassay of endogenous plasma insulin in man. J. Clin. Invest. 39, 1157-1175 (1960).
4. Van Den Broek I, Niessen WMA, Van Dongen WD. Bioanalytical LC-MS/MS of protein-based biopharmaceuticals. J. Chromatogr. B 929, 161-179 (2013).
5. Ewles M, Goodwin L. Bioanalytical approaches to analyzing peptides and proteins by LC-MS/MS. Bioanalysis 3(12), 1379-1397 (2011).
6. Ezan E, Dubois M, Becher F. Bioanalysis of recombinant proteins and antibodies by mass spectrometry. Analyst 134(5), 825-834 (2009).
7. Handbook of LC-MS Bioanalysis: Best Practices, Experimental Prococols, and Regulations. Li W, Zhang J, Tse, FLS (Eds). John Wiley &Sons, Inc., NJ, USA (2013).
8. Berson SA, Yalow RS, Aurbach GD, Potts JT. Immunoassay of bovine and human parathyroid hormone. Proc. Natl Acad. Sci. USA 49(5), 613-617 (1963).
9. Glick SM, Roth J, Yalow RS, Berson SA. Immunoassay of human growth hormone in plasma. Nature 199, 784-787 (1963).
10. Rhyne PW, Wong OT, Zhang YJ, Weiner RS. Electrochemiluminescence in bioanalysis. Bioanalysis 1(5), 919-935 (2009).
11. Luminex. www.luminexcorp.com
12. Meso Scale Discovery. www.mesoscale.com
13. Biacore, GE Healthcare. www.biacore.com
14. ForteBio, Pall Corporation. www.fortebio.com
15. Alpha Technology, PerkinElmer. www.perkinelmer.com/catalog/category/id/ alphatech
16. Accelerating discovery, drug development and disease detection, Singulex. www.singulex.com/technology.html
17. Chimera biotechnology. http://www.chimera-biotec.com/imperacer
18. Siloambio. http://siloambio.com/optimiser-platform-technology
19. ANP Tech. www.anptinc.com
20. EMEA. Guideline on the Clinical Investigation of The Pharmacokinetics of Therapeutic Proteins. European Medicines Agency, London UK (2007).
21. Ezan E. Pharmacokinetic studies of protein drugs: past, present and future. Adv. Drug Deliv. Rev. 65(8), 1065-1073 (2013).
22. Proc JL, Kuzyk MA, Hardie DB et al. A quantitative study of the effects of chaotropic agents, surfactants, and solvents on the digestion efficiency of human plasma proteins by trypsin. J. Proteome Res. 9(10), 5422-5437 (2010).
23. Dubois M, Fenaille F, Clement G et al. Immunopurification and mass spectrometric quantification of the active form of a chimeric therapeutic antibody in human serum. Anal. Chem. 80(5), 1737-1745 (2008).
24. Lu Q, Zheng X, Mcintosh T et al. Development of different analysis platforms with LC-MS for pharmacokinetic studies of protein drugs. Anal. Chem. 81(21), 8715-8723 (2009).
25. Ackermann BL, Berna MJ. Coupling immunoaffinity techniques with MS for quantitative analysis of lowabundance protein biomarkers. Expert Rev. Proteomics 4(2), 175-186 (2007).
26. Holt LJ, Herring C, Jespers LS, Woolven BP, Tomlinson IM. Domain antibodies: proteins for therapy. Trends Biotechnol. 21(11), 484-490 (2003).
27. Sassoon I, Blanc V. Antibody-drug conjugate (ADC) clinical pipeline: a review. Methods Mol. Biol. 1045, 1-27 (2013).
28. Lipovsek D. Adnectins: engineered target-binding protein therapeutics. Protein Eng. Des. Sel. 24(1-2), 3-9 (2011).
29. Stumpp MT, Amstutz P. DARPins: a true alternative to antibodies. Curr. Opin. Drug Discov. Develop. 10(2), 153-159 (2007).
30. Kawe M, Forrer P, Amstutz P, Pluckthun A. Isolation of intracellular proteinase inhibitors derived from designed ankyrin repeat proteins by genetic screening. J. Biol. Chem. 281(52), 40252-40263 (2006).
31. Klein D, Jacobs S, Sheri M et al. Bispecific Centyrin simultaneously targeting EGFR and c-Met demonstrates improved activity compared to the mixture of single agents. Presented at: AACR 104th Annual Meeting 2013. Washington, DC, USA, 6-10 April 2013.
32. Lee JW, Kelley M, King LE et al. Bioanalytical approaches to quantify total and free therapeutic antibodies and their targets: technical challenges and PK/PD applications over the course of drug development. AAPS J. 13(1), 99-110 (2011).
33. Kuang B, King L, Wang HF. Therapeutic monoclonal antibody concentration monitoring: free or total? Bioanalysis 2(6), 1125-1140 (2010).
34. Yang J, Quarmby V. Free versus total ligand-binding assays: points to consider in biotherapeutic drug development. Bioanalysis 3(11), 1163-1165 (2011).
35. Ahene AB. Application and interpretation of free and total drug measurements in the development of biologics. Bioanalysis 3(11), 1287-1295 (2011).
36. Staack RF, Jordan G, Heinrich J. Mathematical simulations for bioanalytical assay development: the (un-)necessity and (im-)possibility of free drug quantification. Bioanalysis 4(4), 381-395 (2012).
37. Hager T, Spahr C, Xu J, Salimi-Moosavi H, Hall M. Differential enzyme-linked immunosorbent assay and ligand-binding mass spectrometry for analysis of biotransformation of protein therapeutics: application to various FGF21 modalities. Anal. Chem. 85(5), 2731-2738 (2013).
38. Hall MP, Gegg C, Walker K et al. Ligand-binding mass spectrometry to study biotransformation of fusion protein drugs and guide immunoassay development: strategic approach and application to peptibodies targeting the thrombopoietin receptor. AAPS J. 12(4), 576-585 (2010).
39. Fernandez Ocana M, James IT, Kabir M et al. Clinical pharmacokinetic assessment of an anti-MAdCAM monoclonal antibody therapeutic by LC-MS/MS. Anal. Chem. 84(14), 5959-5967 (2012).
40. 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).
41. Hecht R, Li YS, Sun J et al. Rationale-based engineering of a potent long-acting fgf21 analog for the treatment of Type 2 diabetes. PLoS ONE 7(11), e49345 (2012).
42. Cuyckens F, Dillen L, Cools W et al. Identifying metabolite ions of peptide drugs in the presence of an in vivo matrix background. Bioanalysis 4(5), 595-604 (2012).
43. Sinha S, Pipes G, Topp EM, Bondarenko PV, Treuheit MJ, Gadgil HS. Comparison of LC and LC/MS methods for quantifying N-glycosylation in recombinant IgGs. J. Am. Soc. Mass Spectrom. 19(11), 1643-1654 (2008).
44. 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).
45. Li H, Ortiz R, Tran LT et al. Simultaneous analysis of multiple monoclonal antibody biotherapeutics by LC-MS/ MS method in rat plasma following cassette-dosing. AAPS J. 15(2), 337-346 (2013).
46. 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).
47. 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).
48. Wang Y, Heilig JS. Differentiation and quantification of endogenous and recombinant-methionyl human leptin in clinical plasma samples by immunocapture/mass spectrometry. J. Pharm. Biomed. Anal. 70, 440-446 (2012).
49. Wang Y, Qu Y, Bellows CL, Ahn JS, Burkey JL, Taylor SW. Simultaneous quantification of davalintide, a novel amylinmimetic peptide, and its active metabolite in beagle and rat plasma by online SPE and LC-MS/MS. Bioanalysis 4(17), 2141-2152 (2012).
50. 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).
51. Morgan P, Van Der Graaf PH, Arrowsmith J et al. Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival. Drug Discov. Today 17(9-10), 419-424 (2012).
52. Szapacs ME, Urbanski JJ, Kehler JR et al. Absolute quantification of a therapeutic domain antibody using ultraperformance liquid chromatography-mass spectrometry and immunoassay. Bioanalysis 2(9), 1597-1608 (2010).
53. Kaur S. Bioanalysis special focus issue on antibody-drug conjugates. Bioanalysis 5(9), 981-983 (2013).
54. Kaur S, Xu K, Saad OM, Dere RC, Carrasco-Triguero M. Bioanalytical assay strategies for the development of antibody-drug conjugate biotherapeutics. Bioanalysis 5(2), 201-226 (2013)