Identification and quantification of host cell protein impurities in biotherapeutics using mass spectrometry

Analytical Biochemistry

Volumn 428, Issue 2, 2012, Pages 150-157

  Schenauer, Matthew R ^a   Flynn, Gregory C ^a   Goetze, Andrew M ^a  

^a AMGEN INC   (United States)

Author keywords

Host cell proteins; Mass spectrometry; Quantification

Indexed keywords

ESCHERICHIA COLI; LIQUID CHROMATOGRAPHY; PEPTIDES;

ENZYME LINKED IMMUNOSORBENT ASSAY; FUTURE APPLICATIONS; HOST CELL PROTEIN; LIMITS OF DETECTION; QUANTIFICATION; QUANTITATIVE ACCURACY; THERAPEUTIC PEPTIDES; TWO-DIMENSIONAL LIQUID CHROMATOGRAPHY;

MASS SPECTROMETRY;

CELL PROTEIN; ESCHERICHIA COLI PROTEIN; FC FUSION PROTEIN; HYBRID PROTEIN; UNCLASSIFIED DRUG;

AMINO ACID SEQUENCE; ARTICLE; DRUG IMPURITY; ESCHERICHIA COLI; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; NONHUMAN; PRIORITY JOURNAL; PROTEIN ANALYSIS; QUANTITATIVE ANALYSIS;

ESCHERICHIA COLI;

EID: 84864406886     PISSN: 00032697     EISSN: 10960309     Source Type: Journal    
DOI: 10.1016/j.ab.2012.05.018     Document Type: Article

References (38)

1. B. Leader, Q.J. Baca, and D.E. Golan Protein therapeutics: a summary and pharmacological classification Nat. Rev. Drug Discov. 7 2008 21 39
2. J.M. Reichert Antibody-based therapeutics to watch in 2011 MAbs 3 2011 76 99
3. K. Maggon Monoclonal antibody "gold rush" Curr. Med. Chem. 14 2007 1978 1987
4. E.W. Leser, and J.A. Asenjo Rational design of purification processes for recombinant proteins J. Chromatogr. 584 1992 43 57
5. A.A. Shukla, and J. Thommes Recent advances in large-scale production of monoclonal antibodies and related proteins Trends Biotechnol. 28 2010 253 261
6. P. Gagnon Polishing methods for monoclonal IgG purification A. Shukla, S. Gadam, M. Etzel, Process Scale Bioseparations for the Biopharmaceutical Industry 2007 Taylor & Francis/CRC Boca Raton, FL 491 505
7. J.R. Bierich Treatment of pituitary dwarfism with biosynthetic growth hormone Acta Paediatr. Scand. Suppl. 325 1986 13 18 (Pubitemid 16029749)
8. X. Wang, A.K. Hunter, and N.M. Mozier Host cell proteins in biologics development: identification, quantitation, and risk assessment Biotechnol. Bioeng. 103 2009 446 458
9. J. Briggs, and P.R. Panfili Quantitation of DNA and protein impurities in biopharmaceuticals Anal. Chem. 63 1991 850 859
10. A.A. Shukla, and P. Hinckley Host cell protein clearance during protein A chromatography: development of an improved column wash step Biotechnol. Prog. 24 2008 1115 1121
11. S.X. Gao, Y. Zhang, K. Stansberry-Perkins, A. Buko, S. Bai, V. Nguyen, and M.L. Brader Fragmentation of a highly purified monoclonal antibody attributed to residual CHO cell protease activity Biotechnol. Bioeng. 108 2011 977 982
12. K. Champion, H. Madden, J. Dougherthy, and E. Shacter Defining your product profile and maintaining control over it: 2. Challenges of monitoring host cell protein impurities BioProcess Int. 3 8 2005 52 57
13. V.R. Anicetti, B.A. Keyt, and W.S. Hancock Purity analysis of protein pharmaceuticals produced by recombinant DNA technology Trends Biotechnol. 7 1989 342 349 (Pubitemid 19284934)
14. A.S. Rathore, S.E. Sobacke, T.J. Kocot, D.R. Morgan, R.L. Dufield, and N.M. Mozier Analysis for residual host cell proteins and DNA in process streams of a recombinant protein product expressed in Escherichia coli cells J. Pharm. Biomed. Anal. 32 2003 1199 1211 (Pubitemid 36930106)
15. US Food and Drug Administration, Notice of pilot program for submission of quality information for biotechnology products in the Office of Biotechnology Products, FDA, docket no. FDA-2008-N-03551, 2008, < http://www.fda.gov/ OHRMS/DOCKETS/98fr/FDA-2008-N-0355-n.pdf >.
16. A.S. Rathore, and H. Winkle Quality by design for biopharmaceuticals Nat. Biotechnol. 27 2009 26 34
17. C.-F. Mandenius, K. Graumann, T.W. Schultz, A. Premstaller, I.M. Olsson, E. Petiot, C. Clemens, and M. Welin Quality-by-design for biotechnology-related pharmaceuticals Biotechnol. J. 4 2009 600 609
18. I.A. Kaltashov, C.E. Bobst, R.R. Abzalimov, G. Wang, B. Baykal, and S. Wang Advances and challenges in analytical characterization of biotechnology products: mass spectrometry-based approaches to study properties and behavior of protein therapeutics Biotechnol. Adv. 30 2012 210 222
19. Z. Zhang, H. Pan, and X. Chen Mass spectrometry for structural characterization of therapeutic antibodies Mass Spectrom. Rev. 28 2009 147 176
20. Y.J. Kim, and M.L. Doyle Structural mass spectrometry in protein therapeutics discovery Anal. Chem. 82 2010 7083 7089
21. R. Aebersold, and M. Mann Mass spectrometry-based proteomics Nature 422 2003 198 207 (Pubitemid 36362757)
22. B. Domon, and R. Aebersold Mass spectrometry and protein analysis Science 312 2006 212 217
23. J.R. Yates, C.I. Ruse, and A. Nakorchevsky Proteomics by mass spectrometry: approaches, advances, and applications Annu. Rev. Biomed. Eng. 11 2009 49 79
24. H.J. Issaq, K.C. Chan, G.M. Janini, T.P. Conrads, and T.D. Veenstra Multidimensional separation of peptides for effective proteomic analysis J. Chromatogr. B 817 2005 35 47 (Pubitemid 40178756)
25. A. Motoyama, and J.R. Yates 3rd Multidimensional LC separations in shotgun proteomics Anal. Chem. 80 2008 7187 7193
26. M.P. Washburn, D. Wolters, and J.R. Yates 3rd Large-scale analysis of the yeast proteome by multidimensional protein identification technology Nat. Biotechnol. 19 2001 242 247 (Pubitemid 32220565)
27. R.H. Bateman, R. Carruthers, J.B. Hoyes, C. Jones, J.I. Langridge, A. Millar, and J.P. Vissers A novel precursor ion discovery method on a hybrid quadrupole orthogonal acceleration time-of-flight (Q-TOF) mass spectrometer for studying protein phosphorylation J. Am. Soc. Mass Spectrom. 13 2002 792 803 (Pubitemid 36871613)
28. E: a new approach for generating molecular fragment information for biomarker structure elucidation Rapid Commun. Mass Spectrom. 20 2006 1989 1994 (Pubitemid 44024575)
29. S.J. Geromanos, J.P. Vissers, J.C. Silva, C.A. Dorschel, G.Z. Li, M.V. Gorenstein, R.H. Bateman, and J.I. Langridge The detection, correlation, and comparison of peptide precursor and product ions from data independent LC-MS with data dependent LC-MS/MS Proteomics 9 2009 1683 1695
30. K. Blackburn, F. Mbeunkui, S.K. Mitra, T. Mentzel, and M.B. Goshe Improving protein and proteome coverage through data-independent multiplexed peptide fragmentation J. Proteome Res. 9 2010 3621 3637
31. J.C. Silva, R. Denny, C. Dorschel, M.V. Gorenstein, G.Z. Li, K. Richardson, D. Wall, and S.J. Geromanos Simultaneous qualitative and quantitative analysis of the Escherichia coli proteome: a sweet tale Mol. Cell. Proteomics 5 2006 589 607
32. J.C. Silva, M.V. Gorenstein, G.Z. Li, J.P. Vissers, and S.J. Geromanos Absolute quantification of proteins by LCMSE: a virtue of parallel MS acquisition Mol. Cell. Proteomics 5 2006 144 156 (Pubitemid 43169347)
33. C. Doneanu, A. Xenopoulos, K. Fadgen, J. Murphy, S.J. Skilton, H. Prentice, M. Stapels, and W. Chen Analysis of host-cell proteins in biotherapeutic proteins by comprehensive online two-dimensional liquid chromatography/mass spectrometry MAbs 4 2012 24 44
34. Y.Q. Yu, M. Gilar, P.J. Lee, E.S. Bouvier, and J.C. Gebler Enzyme-friendly, mass spectrometry-compatible surfactant for in-solution enzymatic digestion of proteins Anal. Chem. 75 2003 6023 6028 (Pubitemid 37356487)
35. M. Gilar, P. Olivova, A.E. Daly, and J.C. Gebler Orthogonality of separation in two-dimensional liquid chromatography Anal. Chem. 77 2005 6426 6434 (Pubitemid 41436983)
36. V.R. Anicetti, E.F. Fehskens, B.R. Reed, A.B. Chen, P. Moore, M.D. Geier, and A.J. Jones Immunoassay for the detection of E. coli proteins in recombinant DNA derived human growth hormone J. Immunol. Methods 91 1986 213 224 (Pubitemid 16003965)
37. L.C. Eaton Host cell contaminant protein assay development for recombinant biopharmaceuticals J. Chromatogr. A 705 1995 105 114
38. D.V. Goeddel, D.G. Kleid, F. Bolivar, H.L. Heyneker, D.G. Yansura, R. Crea, T. Hirose, A. Kraszewski, K. Itakura, and A.D. Riggs Expression in Escherichia coli of chemically synthesized genes for human insulin Proc. Natl. Acad. Sci. USA 76 1979 106 110