A versatile method for protein-based antigen bioanalysis in non-clinical pharmacokinetics studies of a human monoclonal antibody drug by an immunoaffinity liquid chromatography-tandem mass spectrometry

Journal of Chromatography A

Volumn 1334, Issue , 2014, Pages 64-71

  Onami, Ichio ^a   Ayabe, Miho ^a   Murao, Naoaki ^a   Ishigai, Masaki ^a  

^a CHUGAI PHARMACEUTICAL CO LTD   (Japan)

Author keywords

Immune complex; Immunoaffinity; LC MS MS; Receptor activator of nuclear factor B ligand (RANKL)

Indexed keywords

ENZYME LINKED IMMUNOSORBENT ASSAY; HUMANIZED MONOCLONAL ANTIBODY; IMMUNE COMPLEX; IMMUNOAFFINITY; LC-MS/MS; LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROMETRY (LC MS/MS); LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY; NUCLEAR FACTORS;

ANTIGEN-ANTIBODY REACTIONS; BIOASSAY; INTERFERENCE SUPPRESSION; LIGANDS; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MONOCLONAL ANTIBODIES; PHARMACOKINETICS; PROTEINS;

EPITOPES;

ANTIGEN; DENOSUMAB; EPITOPE; IMMUNOGLOBULIN FC FRAGMENT; MONOCLONAL ANTIBODY; OSTEOCLAST DIFFERENTIATION FACTOR; PEPTIDE;

ACCURACY; ANIMAL EXPERIMENT; ANTIBODY SPECIFICITY; ANTIGEN ANTIBODY COMPLEX; ARTICLE; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG PROTEIN BINDING; DRUG SCREENING; ELISA KIT; ENZYME LINKED IMMUNOSORBENT ASSAY; IMMUNOAFFINITY CHROMATOGRAPHY; LIMIT OF QUANTITATION; LIQUID CHROMATOGRAPHY; MAGNETISM; MASS SPECTROMETER; MOUSE; NONHUMAN; PHARMACOKINETICS; PRIORITY JOURNAL; PROTEIN ANALYSIS; REFERENCE VALUE; SINGLE DRUG DOSE; TANDEM MASS SPECTROMETRY; VALIDATION PROCESS;

IMMUNE COMPLEX; IMMUNOAFFINITY; LC-MS/MS; RECEPTOR ACTIVATOR OF NUCLEAR FACTOR-ΚB LIGAND (RANKL);

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; CHROMATOGRAPHY, LIQUID; ENZYME-LINKED IMMUNOSORBENT ASSAY; HUMANS; IMMUNOCHROMATOGRAPHY; IMMUNOMAGNETIC SEPARATION; MICE; MICE, INBRED C57BL; PEPTIDES; RANK LIGAND; TANDEM MASS SPECTROMETRY;

EID: 84896736435     PISSN: 00219673     EISSN: 18733778     Source Type: Journal    
DOI: 10.1016/j.chroma.2014.01.082     Document Type: Article

References (33)

1. Chan A.C., Carter P.J. Nat. Rev. Immunol. 2010, 10:301.
2. Weiner L.M., Surana R., Wang S. Nat. Rev. Immunol. 2010, 10:317.
3. Roskos L.K., Schneider A., Vainshtein I., Schwickart M., Lee R., Lu H., Faggioni R., Liang M. Bioanalysis 2011, 3:659.
4. Lee J.W., Kelley M., King L.E., Yang J., Salimi-Moosavi H., Tang M.T., Lu J.F., Kamerud J., Ahene A., Myler H., Rogers C. AAPS J. 2011, 13:99.
5. Igawa T., Ishii S., Tachibana T., Maeda A., Higuchi Y., Shimaoka S., Moriyama C., Watanabe T., Takubo R., Doi Y., Wakabayashi T., Hayasaka A., Kadono S., Miyazaki T., Haraya K., Sekimori Y., Kojima T., Nabuchi Y., Aso Y., Kawabe Y., Hattori K. Nat. Biotechnol. 2010, 28:1203.
6. Igawa T., Maeda A., Haraya K., Tachibana T., Iwayanagi Y., Mimoto F., Higuchi Y., Ishii S., Tamba S., Hironiwa N., Nagano K., Wakabayashi T., Tsunoda H., Hattori K. PLoS One 2013, 8:e63236.
7. Chaparro-Riggers J., Liang H., DeVay R.M., Bai L., Sutton J.E., Chen W., Geng T., Lindquist K., Casas M.G., Boustany L.M., Brown C.L., Chabot J., Gomes B., Garzone P., Rossi A., Strop P., Shelton D., Pons J., Rajpal A. J. Biol. Chem. 2012, 287:11090.
8. Kim M.S., Lee S.H., Song M.Y., Yoo T.H., Lee B.K., Kim Y.S. J. Mol. Biol. 2007, 374:1374.
9. Arthur K.K., Gabrielson J.P., Hawkins N., Anafi D., Wypych J., Nagi A., Sullivan J.K., Bondarenko P.V. Biochemistry 2012, 51:795.
10. van den Broek I., Niessen W.M., van Dongen W.D. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 2013, 929:161.
11. McIntosh M., Fitzgibbon M. Nat. Biotechnol. 2009, 27:622.
12. Rifai N., Gillette M.A., Carr S.A. Nat. Biotechnol. 2006, 24:971.
13. Carr S.A., Anderson L. Clin. Chem. 2008, 54:1749.
14. Szapacs M.E., Urbanski J.J., Kehler J.R., Wilson R., Boram S.L., Hottenstein C.S., Citerone D.R. Bioanalysis 2010, 2:1597.
15. Hagman C., Ricke D., Ewert S., Bek S., Falchetto R., Bitsch F. Anal. Chem. 2008, 80:1290.
16. Ji C., Sadagopan N., Zhang Y., Lepsy C. Anal. Chem. 2009, 81:9321.
17. Lu Q., Zheng X., McIntosh T., Davis H., Nemeth J.F., Pendley C., Wu S.L., Hancock W.S. Anal. Chem. 2009, 81:8715.
18. Addona T.A., Abbatiello S.E., Schilling B., Skates S.J., Mani D.R., Bunk D.M., Spiegelman C.H., Zimmerman L.J., Ham A.J., Keshishian H., Hall S.C., Allen S., Blackman R.K., Borchers C.H., Buck C., Cardasis H.L., Cusack M.P., Dodder N.G., Gibson B.W., Held J.M., Hiltke T., Jackson A., Johansen E.B., Kinsinger C.R., Li J., Mesri M., Neubert T.A., Niles R.K., Pulsipher T.C., Ransohoff D., Rodriguez H., Rudnick P.A., Smith D., Tabb D.L., Tegeler T.J., Variyath A.M., Vega-Montoto L.J., Wahlander A., Waldemarson S., Wang M., Whiteaker J.R., Zhao L., Anderson N.L., Fisher S.J., Liebler D.C., Paulovich A.G., Regnier F.E., Tempst P., Carr S.A. Nat. Biotechnol. 2009, 27:633.
19. Barnidge D.R., Goodmanson M.K., Klee G.G., Muddiman D.C. J. Proteome Res. 2004, 3:644.
20. Ocana M.F., Neubert H. Anal. Biochem. 2010, 399:202.
21. Ackermann B.L., Berna M.J. Exp. Rev. Proteom. 2007, 4:175.
22. Torsetnes S.B., Lovbak S.G., Claus C., Lund H., Nordlund M.S., Paus E., Halvorsen T.G., Reubsaet L. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 2013, 929:125.
23. Palandra J., Finelli A., Zhu M., Masferrer J., Neubert H. Anal. Chem. 2013, 85:5522.
24. Becker J.O., Hoofnagle A.N. Bioanalysis 2012, 4:281.
25. Neubert H., Muirhead D., Kabir M., Grace C., Cleton A., Arends R. Anal. Chem. 2013, 85:1719.
26. Wong B.R., Rho J., Arron J., Robinson E., Orlinick J., Chao M., Kalachikov S., Cayani E., Bartlett F.S., Frankel W.N., Lee S.Y., Choi Y. J. Biol. Chem. 1997, 272:25190.
27. Lacey D.L., Timms E., Tan H.L., Kelley M.J., Dunstan C.R., Burgess T., Elliott R., Colombero A., Elliott G., Scully S., Hsu H., Sullivan J., Hawkins N., Davy E., Capparelli C., Eli A., Qian Y.X., Kaufman S., Sarosi I., Shalhoub V., Senaldi G., Guo J., Delaney J., Boyle W.J. Cell 1998, 93:165.
28. Luan X., Lu Q., Jiang Y., Zhang S., Wang Q., Yuan H., Zhao W., Wang J., Wang X. J. Immunol. 2012, 189:245.
29. Kostenuik P.J., Nguyen H.Q., McCabe J., Warmington K.S., Kurahara C., Sun N., Chen C., Li L., Cattley R.C., Van G., Scully S., Elliott R., Grisanti M., Morony S., Tan H.L., Asuncion F., Li X., Ominsky M.S., Stolina M., Dwyer D., Dougall W.C., Hawkins N., Boyle W.J., Simonet W.S., Sullivan J.K. J. Bone Miner. Res. 2009, 24:182.
30. Liu J.M., Zhao H.Y., Ning G., Zhao Y.J., Chen Y., Zhang Z., Sun L.H., Xu M.Y., Chen J.L. Calcif. Tissue Int. 2005, 76:1.
31. Bekker P.J., Holloway D.L., Rasmussen A.S., Murphy R., Martin S.W., Leese P.T., Holmes G.B., Dunstan C.R., DePaoli A.M. J. Bone Miner. Res. 2004, 19:1059.
32. Knutsson M., Schmidt R., Timmerman P. Bioanalysis 2013, 5:2211.
33. Bronsema K.J., Bischoff R., van de Merbel N.C. J. Chromatogr. B Anal. Technol. Biomed. Life Sci. 2012, 893-894:1.