Systematic investigation of orthogonal SPE sample preparation for the LC-MS/MS bioanalysis of a monoclonal antibody after pellet digestion

Bioanalysis

Volumn 5, Issue 19, 2013, Pages 2379-2391

  Yuan, Long ^a   Aubry, Anne Françoise ^a   Arnold, Mark E ^a   Ji, Qin C ^a  

^a BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BMS 986012; MONOCLONAL ANTIBODY; PEPTIDE; UNCLASSIFIED DRUG;

ARTICLE; BLOOD ANALYSIS; CATION EXCHANGE; CONTROLLED STUDY; EXTRACTION; HAPLORHINI; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; NOISE REDUCTION; NONHUMAN; PELLET DIGESTION; PROCESS OPTIMIZATION; SENSITIVITY AND SPECIFICITY; SOLID PHASE EXTRACTION; ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY;

AMINO ACID SEQUENCE; ANIMALS; ANTIBODIES, MONOCLONAL; BLOOD PROTEINS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HAPLORHINI; HUMANS; ISOTOPE LABELING; PEPTIDES; SOLID PHASE EXTRACTION; TANDEM MASS SPECTROMETRY; TRYPSIN;

EID: 84885234503     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.13.224     Document Type: Article

References (25)

1. Deng R, Jin F, Prabhu S, Iyer S. Monoclonal antibodies: what are the pharmacokinetic and pharmacodynamic considerations for drug development? Expert Opin. Drug Metab. Toxicol. 8(2), 141-160 (2012).
2. Ezan E, Bitsch F. Critical comparison of MS and immunoassays for the bioanalysis of therapeutic antibodies. Bioanalysis 1(8), 1375-1388 (2009).
3. Shi T, Su D, Liu T et al. Advancing the sensitivity of selected reaction monitoring-based targeted quantitative proteomics. Proteomics 12(8), 1074-1092 (2012).
4. Yang Z, Hayes M, Fang X, Daley MP, Ettenberg S, Tse FLS. LC-MS/MS approach for quantification of therapeutic proteins in plasma using a protein internal standard and 2D-solid-phase extraction clean-up. Anal. Chem. 79(24), 9294-9301 (2007).
5. 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).
6. Heudi O, Barteau S, Zimmer D et al. Towards absolute quantification of therapeutic monoclonal antibody in serum by LC-MS/MS using isotope-labeled antibody standard and protein cleavage isotope dilution mass spectrometry. Anal. Chem. 80(11), 4200-4207 (2008).
7. 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).
8. Duan X, Abuqayyas L, Dai L, Balthasar JP, Qu J. High-throughput method development for sensitive, accurate, and reproducible quantification of therapeutic monoclonal antibodies in tissues using orthogonal array optimization and nano liquid chromatography/selected reaction monitoring mass spectrometry. Anal. Chem. 84(10), 4373-4382 (2012).
9. Fernández Ocaña 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).
10. Neubert H, Muirhead D, Kabir M, Grace C, Cleton A, Arends R. Sequential protein and peptide immunoaffinity capture for mass spectrometry-based quantification of total human b-nerve growth factor. Anal. Chem. 85(3), 1719-1726 (2012).
11. Wu ST, Ouyang Z, Olah TV, Jemal M. A strategy for liquid chromatography-tandem mass spectrometry based quantitation of pegylated protein drugs in plasma using plasma protein precipitation with water-miscible organic solvents and subsequent trypsin digestion to generate surrogate peptides for detection. Rapid Commun. Mass Spectrom. 25(2), 281-290 (2011).
12. Liu G, Ji QC, Dodge R et al. Liquid chromatography coupled with tandem mass spectrometry for the bioanalysis of proteins in drug development: practical considerations in assay development and validation. J. Chromatogr. A 1284(0), 155-162 (2013).
13. Yang Z, Ke J, Hayes M, Bryant M, Tse FLS. A sensitive and high-throughput LC-MS/MS method for the quantification of pegylated-interferon-alpha2a in human serum using monolithic C18 solid phase extraction for enrichment. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 877(18-19), 1737-1742 (2009).
14. Duan X, Dai L, Chen S-C, Balthasar JP, Qu J. Nano-scale liquid chromatography-mass spectrometry and on-the-fly orthogonal array optimization for quantification of therapeutic monoclonal antibodies and the application in preclinical analysis. J. Chromatogr. A 1251(0), 63-73 (2012).
15. Ewles M, Goodwin L. Bioanalytical approaches to analyzing peptides and proteins by LC-MS/MS. Bioanalysis 3(12), 1379-1397 (2011).
16. Li F, Fast D, Michael S. Absolute quantitation of protein therapeutics in biological matrices by enzymatic digestion and LC-MS. Bioanalysis 3(21), 2459-2480 (2011).
17. van den Broek I, Niessen WMA, van Dongen WD. Bioanalytical LC-MS/MS of protein-based biopharmaceuticals. J. Chromatogr. B 929(0), 161-179 (2013).
18. Addona TA, Abbatiello SE, Schilling B et al. Multi-site assessment of the precision and reproducibility of multiple reaction monitoring-based measurements of proteins in plasma. Nat. Biotechnol. 27(7), 633-641 (2009).
19. 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).
20. Yuan L, Arnold ME, Aubry A-F, Ji QC. Simple and efficient digestion of a monoclonal antibody in serum using pellet digestion: comparison with traditional digestion methods in LC-MS/MS bioanalysis. Bioanalysis 4(24), 2887-2896 (2012).
21. Shen JX, Wang H, Tadros S, Hayes RN. Orthogonal extraction/chromatography and UPLC, two powerful new techniques for bioanalytical quantitation of desloratadine and 3-hydroxydesloratadine at 25 pg/ml. J. Pharm. Biomed. Anal. 40(3), 689-706 (2006).
22. Xue YJ, Akinsanya JB, Liu J, Unger SE. A simplified protein precipitation/mixed-mode cation-exchange solid-phase extraction, followed by high-speed liquid chromatography-mass spectrometry, for the determination of a basic drug in human plasma. Rapid Commun. Mass Spectrom. 20(18), 2660-2668 (2006).
23. Jemal M, Ouyang Z, Xia YQ. Systematic LC-MS/MS bioanalytical method development that incorporates plasma phospholipids risk avoidance, usage of incurred sample and well thought-out chromatography. Biomed. Chromatogr. 24(1), 2-19 (2010).
24. Xia YQ, Jemal M. Phospholipids in liquid chromatography-mass spectrometry bioanalysis: Comparison of three tandem mass spectrometric techniques for monitoring plasma phospholipids, the effect of mobile phase composition on phospholipids elution and the association of phospholipids with matrix effects. Rapid Commun. Mass Spectrom. 23(14), 2125-2138 (2009).
25. 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).