Characterization of biopharmaceuticals by NMR spectroscopy

TrAC - Trends in Analytical Chemistry

Volumn 48, Issue , 2013, Pages 96-111

  Wishart, David S ^a,b  

^a UNIVERSITY OF ALBERTA   (Canada)

^b NATIONAL RESEARCH COUNCIL CANADA   (Canada)

Author keywords

Biopharmaceuticals; Biosimilar; Characterization; Formulation; Nuclear magnetic resonance (NMR); Oligonucleotide; Peptide; Polysaccharide; Protein; Quality control

Indexed keywords

NUCLEAR MAGNETIC RESONANCE; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; OLIGONUCLEOTIDES; PEPTIDES; POLYSACCHARIDES; PROTEINS; QUALITY CONTROL;

BIOPHARMACEUTICALS; BIOSIMILAR; BIOTECH DRUGS; EMERGING TRENDS; FORMULATION; NUCLEAR MAGNETIC RESONANCE(NMR); REAL-WORLD; SPECTRAL PROCESSING;

CHARACTERIZATION;

ANTISENSE OLIGONUCLEOTIDE; BIOLOGICAL PRODUCT; BIOPHARMACEUTICAL AGENT; BIOSIMILAR AGENT; EXCIPIENT; PEPTIDE DERIVATIVE; POLYSACCHARIDE; PROTEIN DERIVATIVE; UNCLASSIFIED DRUG; VACCINE;

AUTOMATION; BIOTECHNOLOGY; CIRCULAR DICHROISM; DRUG DESIGN; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG FORMULATION; DRUG QUALITY; DRUG STRUCTURE; HUMAN; INFRARED SPECTROSCOPY; INTERMETHOD COMPARISON; MASS SPECTROMETRY; NONHUMAN; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; SENSITIVITY ANALYSIS; X RAY DIFFRACTION;

EID: 84879462701     PISSN: 01659936     EISSN: 18793142     Source Type: Journal    
DOI: 10.1016/j.trac.2013.03.009     Document Type: Review

References (80)

1. Knox C., Law V., Jewison T., Liu P., Ly S., Frolkis A., Pon A., Banco K., Mak C., Neveu V., Djoumbou Y., Eisner R., Guo A.C., Wishart D.S. Nucleic Acids Res. 2011, 39:D1035.
2. Walsh G. Pharmaceutical Biotechnology: Concepts and Applications 2007, John Wiley & Sons, Chichester, West Sussex, UK.
3. Whitman R. Pharmaceutical Company Outlook to 2014, DMHC2591 2009, Datamonitor, London.
4. Keeler J. Understanding NMR Spectroscopy 2005, John Wiley & Sons, Chichester, West Sussex, UK.
5. Cavanagh J., Fairbrother W.J., Palmer A.G., Skelton N.J., Rance M. Protein NMR Spectroscopy: Principles and Practice 2006, Academic Press, San Diego, CA, USA. Second Edition.
6. Rabi I.I., Zacharias J.R., Millman S., Kusch P. Phys. Rev. 1938, 53:318.
7. Purcell E., Torrey H., Pound R. Phys. Rev. 1946, 69:37.
8. Nagayama K., Wuthrich K., Ernst R.R. Biochem. Biophys. Res. Comm. 1979, 90:305.
9. Berman H.M., Westbrook J., Feng Z., Gilliland G., Bhat T.N., Weissig H., Shindyalov I.N., Bourne P.E. Nucleic Acids Res. 2000, 28:235.
10. Brey W.W., Edison A.S., Nast R.E., Rocca J.R., Saha S., Withers R.S. J. Magn. Reson. 2006, 179:290.
11. Fratila R.M., Velders A.H. Annu. Rev. Anal. Chem. 2011, 4:227.
12. Tugarinov V., Hwang P.M., Kay L.E. Annu. Rev. Biochem. 2004, 73:107.
13. Delaglio F., Grzesiek S., Vuister G.W., Zhu G., Pfeifer J., Bax A. J. Biomol. NMR 1995, 6:277.
14. Kay L.E. J. Magn. Reson. 2005, 173:193.
15. Zang Q., Keire D.A., Buhse L.F., Wood R.D., Mital D.P., Haque S., Srinivasan S., Moore C.M., Nasr M., Al-Hakim A., Trehy M.L., Welsh W.J. Anal. Bioanal. Chem. 2011, 401:939.
16. Bhunia A., Bhattacharjya S., Chatterjee S. Drug Discov. Today 2012, 17:505.
17. Wishart D.S. Trends Anal. Chem. 2008, 27:228.
18. Seeley E.H., Schwamborn K., Caprioli R.M. J. Biol. Chem. 2011, 286:25459.
19. Battacharya A. Nature (London) 2010, 463:605.
20. Lin Y., Schiavo S., Orjala J., Vouros P., Kautz R. Anal. Chem. 2008, 80:8045.
21. Singh S., Handa T., Narayanam M., Sahu A., Junwal M., Shah R.P. J. Pharm. Biomed. Anal. 2012, 69:148.
22. Voehler M.W., Collier G., Young J.K., Stone M.P., Germann M.W. J. Magn. Reson. 2006, 183:102.
23. Hautbergue G.M., Golovanov A.P. J. Magn. Reson. 2008, 191:335.
24. Jansma A., Chuan T., Albrecht R.W., Olson D.L., Peck T.L., Geierstanger B.H. Anal. Chem. 2005, 77:6509.
25. Shapiro M.J., Wareing J.R. Curr. Opin. Chem. Biol. 1998, 2:372.
26. Aguilar J.A., Faulkner S., Nilsson M., Morris G.A. Angew. Chem., Int. Ed. Engl. 2010, 49:3901.
27. Ikura M., Kay L.E., Bax A. Biochemistry 1990, 29:4659.
28. Kupce E., Freeman R. J. Biomol. NMR 2003, 25:349.
29. Atreya H.S. J. Indian Inst. Sci. 2010, 90:87.
30. Schanda P., Brutscher B. J. Magn. Reson 2006, 178:334.
31. Renault M., Cukkemane A., Baldus M. Angew. Chem., Int. Ed. Engl. 2010, 49:8346.
32. Bayet-Robert M., Loiseau D., Rio P., Demidem A., Barthomeuf C., Stepien G., Morvan D. Magn. Reson. Med. 2010, 63:1172.
33. Renault M., Tommassen-van Boxtel R., Bos M.P., Post J.A., Tommassen J., Baldus Proc M. Natl. Acad. Sci. USA 2012, 109:4863.
34. Tycko R. Annu. Rev. Phys. Chem. 2011, 62:279.
35. Kelley W.P., Chen S., Floyd P.D., Hu P., Kapsi S.G., Kord A.S., Sun M., Vogt F.G. Anal. Chem. 2012, 84:4357.
36. Bathen T.F., Sitter B., Sjøbakk T.E., Tessem M.B., Gribbestad I.S. Cancer Res. 2010, 70:6692.
37. Barnes A.B., Paëpe G.D., van der Wel P.C., Hu K.N., Joo C.G., Bajaj V.S., Mak-Jurkauskas M.L., Sirigiri J.R., Herzfeld J., Temkin R.J., Griffin R.G. Appl. Magn. Reson. 2008, 34:237.
38. Molinksi T. Curr. Opin. Biotechnol. 2010, 21:819.
39. Lerche M.H., Meier S., Jensen P.R., Hustvedt S.O., Karlsson M., Duus J.O., Ardenkjaer-Larsen J.H. NMR Biomed. 2011, 24:96.
40. Wishart D. Curr. Pharm. Biotechnol. 2005, 6:105.
41. Lattman E. Proteins 2004, 54:611.
42. Güntert P. Eur. Biophys. J. 2009, 38:129.
43. Guerry P., Herrmann T. Methods Mol. Biol. 2012, 831:429.
44. Moseley H.N., Montelione G.T. Curr. Opin. Struct. Biol. 1999, 9:635.
45. Wishart D.S. Curr. Progress NMR Spectrosc. 2011, 58:62.
46. Barton S., Heng X., Johnson B.A., Summers M.F. J. Biomol. NMR 2013, 55:33.
47. Nilges M., Macias M.J., O'Donoghue S.I., Oschkinat H. J. Mol. Biol. 1997, 269:408.
48. Guntert P., Rev Q. Biophys. 1998, 31:145.
49. Berjanskii M., Zhou J., Liang Y., Lin G., Wishart D.S. J. Biomol. NMR 2012, 53:167.
50. Huang Y.J., Rosato A., Singh G., Montelione G.T. Nucleic Acids Res. 2012, 40:W542.
51. Doreleijers J.F., Sousa da Silva A.W., Krieger E., Nabuurs S.B., Spronk C.A., Stevens T.J., Vranken W.F., Vriend G., Vuister G.W. J. Biomol. NMR 2012, 54:267.
52. Berjanskii M., Tang P., Liang J., Cruz J.A., Zhou J., Zhou Y., Bassett E., MacDonell C., Lu P., Lin G., Wishart D.S. Nucleic Acids Res. 2009, 37:W670.
53. Raman S., Lange O.F., Rossi P., Tyka M., Wang X., Aramini J., Liu G., Ramelot T.A., Eletsky A., Szyperski T., Kennedy M.A., Prestegard J., Montelione G.T., Baker D. Science (Washington, DC) 2010, 327:1014.
54. Berjanskii M.V., Wishart D.S. J. Biomol. NMR 2008, 40:31.
55. Wishart D.S. Drugs R&D 2008, 9:307.
56. Hao J., Astle W., De Iorio M., Ebbels T.M. Bioinformatics 2012, 28:2088.
57. Mercier P., Lewis M.J., Chang D., Baker D., Wishart D.S. J. Biomol. NMR 2011, 49:307.
58. Xia J., Bjorndahl T.C., Tang P., Wishart D.S. BMC Bioinform. 2008, 9:507.
59. Meriage D., Rogers G., Phillips J. PDA J. Pharm. Sci. Technol. 2012, 66:547.
60. Stark J.L., Powers R. Top. Curr. Chem. 2012, 326:1.
61. Tisné C., Guillière F., Dardel F. Biochimie 2005, 87:885.
62. Tsantrizos Y.S. Biopolymers 2004, 76:309.
63. Madine J., Doig A.J., Middleton D.A. J. Am. Chem. Soc. 2008, 130:7873.
64. Wilkinson I.C., Hall C.J., Veverka V., Shi J.Y., Muskett F.W., Stephens P.E., Taylor R.J., Henry A.J., Carr M.D. J. Biol. Chem. 2009, 284:31928.
65. Bondensgaard K., Breinholt J., Madsen D., Omkvist D.H., Kang L., Worsaae A., Becker P., Schiødt C.B., Hjorth S.A. J. Biol. Chem. 2007, 282:23326.
66. Rudd T.R., Yates E.A., Hricovíni M. Curr. Med. Chem. 2009, 16:4750.
67. Guerrini M., Guglieri S., Naggi A., Sasisekharan R., Torri G. Semin. Thromb. Hemost. 2007, 33:478.
68. Daly N.L., Rosengren K.J., Henriques S.T., Craik D.J. Eur. Biophys. J. 2011, 40:359.
69. Lindon J.C., Holmes E., Nicholson J.K. FEBS J. 2007, 274:1140.
70. Serkova N., Litt L., James T.L., Sadée S., Leibfritz D., Benet L.Z., Christians U. J. Pharmacol. Exp. Ther. 1999, 289:800.
71. Klawitter J., Haschke M., Kahle C., Dingmann C., Klawitter J., Leibfritz D., Christians U. Br. J. Clin. Pharmacol. 2010, 70:241.
72. Sauvé S., Gingras G., Aubin Y. Biomol. NMR Assign. 2012, 6:189.
73. Aubin Y., Jones C., Freedberg D.I. Biopharm. Int. Supp. Aug. 2010, 2:1.
74. Vipond C., Mulloy B., Rigsby P., Burkin K., Bolgiano B. Biologicals 2012, 40:353.
75. Beyer T., Diehl B., Randel G., Humpfer E., Schäfer H., Spraul M., Schollmayer C., Holzgrabe U. J. Pharm. Biomed. Anal. 2008, 48:13.
76. Mourier P.A., Guichard O.Y., Herman F., Viskov C. J. Pharm. Biomed. 2011, 54:337.
77. Ohno A., Kawasaki N., Fukuhara K., Okuda H., Yamaguchi T. Chem. Pharm. Bull. (Tokyo) 2009, 57:1396.
78. Skidmore K., Hewitt D., Kao Y.H. Biotechnol. Prog. 2012, 28:1526.
79. Aubin Y., Gingras G., Sauvé S. Anal. Chem. 2008, 80:2623.
80. Berkowitz S.A., Engen J.R., Mazzeo J.R., Jones G.B. Nat. Rev. Drug Discov. 2012, 11:527.