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Volumn 14, Issue 3, 2012, Pages 530-541

A platform for characterizing therapeutic monoclonal antibody breakdown products by 2D chromatography and top-down mass spectrometry

Author keywords

2D chromatography; liquid chromatography mass spectrometry (LC MS); tandem mass spectrometry (MS MS); therapeutic monoclonal antibodies

Indexed keywords

IMMUNOGLOBULIN F(AB) FRAGMENT; IMMUNOGLOBULIN HEAVY CHAIN; IMMUNOGLOBULIN LIGHT CHAIN; MONOCLONAL ANTIBODY;

EID: 84862759792     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9361-6     Document Type: Article
Times cited : (37)

References (29)
  • 1
    • 80051941878 scopus 로고    scopus 로고
    • Therapeutic monoclonal antibodies
    • 21720199 10.2302/kjm.60.37 1:CAS:528:DC%2BC3MXht1Wms7nJ
    • T Yamada 2011 Therapeutic monoclonal antibodies Keio J Med 60 37 46 21720199 10.2302/kjm.60.37 1:CAS:528:DC%2BC3MXht1Wms7nJ
    • (2011) Keio J Med , vol.60 , pp. 37-46
    • Yamada, T.1
  • 2
    • 33644619972 scopus 로고    scopus 로고
    • Heterogeneity of recombinant antibodies: Linking structure to function
    • 1:CAS:528:DC%2BD28XntVOgsw%3D%3D
    • RJ Harris 2005 Heterogeneity of recombinant antibodies: linking structure to function Dev Biol (Basel) 122 117 127 1:CAS:528:DC%2BD28XntVOgsw%3D%3D
    • (2005) Dev Biol (Basel) , vol.122 , pp. 117-127
    • Harris, R.J.1
  • 4
    • 70649100426 scopus 로고    scopus 로고
    • Identification of codon-specific serine to asparagine mistranslation in recombinant monoclonal antibodies by high-resolution mass spectrometry
    • 19852494 10.1021/ac901541h 1:CAS:528:DC%2BD1MXhtlSlsLzN
    • XC Yu OV Borisov M Alvarez DA Michels YJ Wang V Ling 2009 Identification of codon-specific serine to asparagine mistranslation in recombinant monoclonal antibodies by high-resolution mass spectrometry Anal Chem 81 9282 9290 19852494 10.1021/ac901541h 1:CAS:528:DC%2BD1MXhtlSlsLzN
    • (2009) Anal Chem , vol.81 , pp. 9282-9290
    • Yu, X.C.1    Borisov, O.V.2    Alvarez, M.3    Michels, D.A.4    Wang, Y.J.5    Ling, V.6
  • 5
    • 8344224534 scopus 로고    scopus 로고
    • Characterizing biological products and assessing comparability following manufacturing changes
    • 10.1038/nbt1030 1:CAS:528:DC%2BD2cXptlSlsL8%3D
    • AJ Chirino A Mire-Sluis 2004 Characterizing biological products and assessing comparability following manufacturing changes Nat Biotech 22 1383 1391 10.1038/nbt1030 1:CAS:528:DC%2BD2cXptlSlsL8%3D
    • (2004) Nat Biotech , vol.22 , pp. 1383-1391
    • Chirino, A.J.1    Mire-Sluis, A.2
  • 8
    • 0025753494 scopus 로고
    • Quantitation of DNA and protein impurities in biopharmaceuticals
    • 1858980 10.1021/ac00009a003 1:CAS:528:DyaK3MXhslWgur4%3D
    • J Briggs PR Panfili 1991 Quantitation of DNA and protein impurities in biopharmaceuticals Anal Chem 63 850 859 1858980 10.1021/ac00009a003 1:CAS:528:DyaK3MXhslWgur4%3D
    • (1991) Anal Chem , vol.63 , pp. 850-859
    • Briggs, J.1    Panfili, P.R.2
  • 9
    • 28444439937 scopus 로고    scopus 로고
    • A quantitative slot blot assay for host cell protein impurities in recombinant proteins expressed in E. coli
    • 16137696 10.1016/j.jim.2005.07.021 1:CAS:528:DC%2BD2MXhtlSjt7zE
    • D Zhu AJ Saul AP Miles 2005 A quantitative slot blot assay for host cell protein impurities in recombinant proteins expressed in E. coli J Immunol Methods 306 40 50 16137696 10.1016/j.jim.2005.07.021 1:CAS:528: DC%2BD2MXhtlSjt7zE
    • (2005) J Immunol Methods , vol.306 , pp. 40-50
    • Zhu, D.1    Saul, A.J.2    Miles, A.P.3
  • 10
    • 0042202405 scopus 로고    scopus 로고
    • Analysis for residual host cell proteins and DNA in process streams of a recombinant protein product expressed in Escherichia coli cells
    • 12907264 10.1016/S0731-7085(03)00157-2 1:CAS:528:DC%2BD3sXlvFygs70%3D
    • AS Rathore SE Sobacke TJ Kocot DR Morgan RL Dufield NM Mozier 2003 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 1199 1211 12907264 10.1016/S0731-7085(03)00157-2 1:CAS:528: DC%2BD3sXlvFygs70%3D
    • (2003) J Pharm Biomed Anal , vol.32 , pp. 1199-1211
    • Rathore, A.S.1    Sobacke, S.E.2    Kocot, T.J.3    Morgan, D.R.4    Dufield, R.L.5    Mozier, N.M.6
  • 11
    • 33644744918 scopus 로고    scopus 로고
    • Assays for controlling host-cell impurities in biopharmaceuticals
    • 1:CAS:528:DC%2BD2MXit1yisLY%3D
    • T Wolter A Richter 2005 Assays for controlling host-cell impurities in biopharmaceuticals BioProcess Int 3 40 46 1:CAS:528:DC%2BD2MXit1yisLY%3D
    • (2005) BioProcess Int , vol.3 , pp. 40-46
    • Wolter, T.1    Richter, A.2
  • 12
    • 77951277134 scopus 로고    scopus 로고
    • On developing a process for conducting extractable Leachable assessment of components used for storage of biopharmaceuticals
    • 20039383 10.1002/jps.22012 1:CAS:528:DC%2BC3cXjt1agsbc%3D
    • AA Wakankar YJ Wang E Canova-Davis S Ma D Schmalzing J Grieco, et al. 2010 On developing a process for conducting extractable Leachable assessment of components used for storage of biopharmaceuticals J Pharm Sci 99 2209 2218 20039383 10.1002/jps.22012 1:CAS:528:DC%2BC3cXjt1agsbc%3D
    • (2010) J Pharm Sci , vol.99 , pp. 2209-2218
    • Wakankar, A.A.1    Wang, Y.J.2    Canova-Davis, E.3    Ma, S.4    Schmalzing, D.5    Grieco, J.6
  • 13
    • 33747771382 scopus 로고    scopus 로고
    • Chromatographic and electrophoretic characterization of protein variants
    • 16872917 10.1016/j.jchromb.2006.05.044 1:CAS:528:DC%2BD28XovVSjsr0%3D
    • K Ahrer A Jungbauer 2006 Chromatographic and electrophoretic characterization of protein variants J Chromatogr B Analyt Technol Biomed Life Sci 841 110 122 16872917 10.1016/j.jchromb.2006.05.044 1:CAS:528: DC%2BD28XovVSjsr0%3D
    • (2006) J Chromatogr B Analyt Technol Biomed Life Sci , vol.841 , pp. 110-122
    • Ahrer, K.1    Jungbauer, A.2
  • 14
    • 80054970831 scopus 로고    scopus 로고
    • On-line characterization of monoclonal antibody variants by liquid chromatography mass spectrometry operating in a two-dimensional format
    • 21867674 10.1016/j.ab.2011.07.033 1:CAS:528:DC%2BC3MXht1agt73O
    • M Alvarez G Tremintin J Wang M Eng YH Kao J Jeong, et al. 2011 On-line characterization of monoclonal antibody variants by liquid chromatography mass spectrometry operating in a two-dimensional format Anal Biochem 419 17 25 21867674 10.1016/j.ab.2011.07.033 1:CAS:528:DC%2BC3MXht1agt73O
    • (2011) Anal Biochem , vol.419 , pp. 17-25
    • Alvarez, M.1    Tremintin, G.2    Wang, J.3    Eng, M.4    Kao, Y.H.5    Jeong, J.6
  • 15
    • 77957333488 scopus 로고    scopus 로고
    • Mass spectrometric analysis of intact human monoclonal antibody aggregates fractionated by size-exclusion chromatography
    • 20680668 10.1007/s11095-010-0224-5
    • B Kukrer V Filipe E van Duijn P Kasper R Vreeken A Heck, et al. 2010 Mass spectrometric analysis of intact human monoclonal antibody aggregates fractionated by size-exclusion chromatography Pharm Res 27 2197 2204 20680668 10.1007/s11095-010-0224-5
    • (2010) Pharm Res , vol.27 , pp. 2197-2204
    • Kukrer, B.1    Filipe, V.2    Van Duijn, E.3    Kasper, P.4    Vreeken, R.5    Heck, A.6
  • 16
    • 3042761213 scopus 로고    scopus 로고
    • Structure-immunogenicity relationships of therapeutic proteins
    • 15212151 10.1023/B:PHAM.0000029275.41323.a6 1:CAS:528: DC%2BD2cXktlykurY%3D
    • S Hermeling D Crommelin H Schellekens W Jiskoot 2004 Structure- immunogenicity relationships of therapeutic proteins Pharm Res 21 897 903 15212151 10.1023/B:PHAM.0000029275.41323.a6 1:CAS:528:DC%2BD2cXktlykurY%3D
    • (2004) Pharm Res , vol.21 , pp. 897-903
    • Hermeling, S.1    Crommelin, D.2    Schellekens, H.3    Jiskoot, W.4
  • 18
    • 0024806396 scopus 로고
    • Stability of protein pharmaceuticals
    • 2687836 10.1023/A:1015929109894 1:CAS:528:DyaK3cXkt1aruw%3D%3D
    • MC Manning K Patel RT Borchardt 1989 Stability of protein pharmaceuticals Pharm Res 6 903 918 2687836 10.1023/A:1015929109894 1:CAS:528: DyaK3cXkt1aruw%3D%3D
    • (1989) Pharm Res , vol.6 , pp. 903-918
    • Manning, M.C.1    Patel, K.2    Borchardt, R.T.3
  • 19
    • 68249159733 scopus 로고    scopus 로고
    • A multi-tiered analytical approach for the analysis and quantitation of high-molecular-weight aggregates in a recombinant therapeutic glycoprotein
    • 19430910 10.1208/s12248-009-9108-1 1:CAS:528:DC%2BD1MXhtVWqs7vN
    • H Hughes C Morgan E Brunyak K Barranco E Cohen T Edmunds, et al. 2009 A multi-tiered analytical approach for the analysis and quantitation of high-molecular-weight aggregates in a recombinant therapeutic glycoprotein AAPS J 11 335 341 19430910 10.1208/s12248-009-9108-1 1:CAS:528:DC%2BD1MXhtVWqs7vN
    • (2009) AAPS J , vol.11 , pp. 335-341
    • Hughes, H.1    Morgan, C.2    Brunyak, E.3    Barranco, K.4    Cohen, E.5    Edmunds, T.6
  • 20
    • 33749452453 scopus 로고    scopus 로고
    • A critical review of analytical ultracentrifugation and field flow fractionation methods for measuring protein aggregation
    • 17025276 10.1208/aapsj080367 1:CAS:528:DC%2BD28XhtV2iurnM
    • J Liu J Andya S Shire 2006 A critical review of analytical ultracentrifugation and field flow fractionation methods for measuring protein aggregation AAPS J 8 E580 E589 17025276 10.1208/aapsj080367 1:CAS:528: DC%2BD28XhtV2iurnM
    • (2006) AAPS J , vol.8
    • Liu, J.1    Andya, J.2    Shire, S.3
  • 22
    • 17044393960 scopus 로고    scopus 로고
    • UPLC: An introduction and review
    • 10.1081/JLC-200053046 1:CAS:528:DC%2BD2MXjsF2lsr8%3D
    • ME Swartz 2005 UPLC: an introduction and review J Liq Chromatogr Relat Technol 28 1253 1263 10.1081/JLC-200053046 1:CAS:528:DC%2BD2MXjsF2lsr8%3D
    • (2005) J Liq Chromatogr Relat Technol , vol.28 , pp. 1253-1263
    • Swartz, M.E.1
  • 23
    • 0037442650 scopus 로고    scopus 로고
    • High-throughput protein sequencing
    • 12622379 10.1021/ac0206317 1:CAS:528:DC%2BD3sXksFensQ%3D%3D
    • V Pham J Tropea S Wong J Quach WJ Henzel 2003 High-throughput protein sequencing Anal Chem 75 875 882 12622379 10.1021/ac0206317 1:CAS:528: DC%2BD3sXksFensQ%3D%3D
    • (2003) Anal Chem , vol.75 , pp. 875-882
    • Pham, V.1    Tropea, J.2    Wong, S.3    Quach, J.4    Henzel, W.J.5
  • 24
    • 0034133274 scopus 로고    scopus 로고
    • Electron capture dissociation for structural characterization of multiply charged protein cations
    • 10695143 10.1021/ac990811p 1:CAS:528:DC%2BD3cXmsFeg
    • RA Zubarev DM Horn EK Fridriksson NL Kelleher NA Kruger MA Lewis, et al. 2000 Electron capture dissociation for structural characterization of multiply charged protein cations Anal Chem 72 563 573 10695143 10.1021/ac990811p 1:CAS:528:DC%2BD3cXmsFeg
    • (2000) Anal Chem , vol.72 , pp. 563-573
    • Zubarev, R.A.1    Horn, D.M.2    Fridriksson, E.K.3    Kelleher, N.L.4    Kruger, N.A.5    Lewis, M.A.6
  • 25
    • 34249022000 scopus 로고    scopus 로고
    • Implementation of electron-transfer dissociation on a hybrid linear ion trap-orbitrap mass spectrometer
    • 17441688 10.1021/ac070020k 1:CAS:528:DC%2BD2sXkt1Oru7c%3D
    • GC McAlister D Phanstiel DM Good WT Berggren JJ Coon 2007 Implementation of electron-transfer dissociation on a hybrid linear ion trap-orbitrap mass spectrometer Anal Chem 79 3525 3534 17441688 10.1021/ac070020k 1:CAS:528:DC%2BD2sXkt1Oru7c%3D
    • (2007) Anal Chem , vol.79 , pp. 3525-3534
    • McAlister, G.C.1    Phanstiel, D.2    Good, D.M.3    Berggren, W.T.4    Coon, J.J.5
  • 26
    • 0036315870 scopus 로고    scopus 로고
    • Top down protein characterization via tandem mass spectrometry
    • 12124999 10.1002/jms.346 1:CAS:528:DC%2BD38XlvFKmsbg%3D
    • GE Reid SA McLuckey 2002 Top down protein characterization via tandem mass spectrometry J Mass Spectrom 37 663 675 12124999 10.1002/jms.346 1:CAS:528:DC%2BD38XlvFKmsbg%3D
    • (2002) J Mass Spectrom , vol.37 , pp. 663-675
    • Reid, G.E.1    McLuckey, S.A.2
  • 27
    • 23444455214 scopus 로고    scopus 로고
    • Chip-based nanoelectrospray mass spectrometry for protein characterization
    • 15966841 10.1586/14789450.1.4.449 1:CAS:528:DC%2BD2cXhtVyqtr3I
    • S Zhang CK Van Pelt 2004 Chip-based nanoelectrospray mass spectrometry for protein characterization Expert Rev Proteomics 1 449 468 15966841 10.1586/14789450.1.4.449 1:CAS:528:DC%2BD2cXhtVyqtr3I
    • (2004) Expert Rev Proteomics , vol.1 , pp. 449-468
    • Zhang, S.1    Van Pelt, C.K.2
  • 28
    • 84867564254 scopus 로고    scopus 로고
    • Characterization of a fully automated nanoelectrospray system with mass spectrometric detection for proteomic analyses
    • 19498969
    • C Van Pelt S Zhang J Henion 2002 Characterization of a fully automated nanoelectrospray system with mass spectrometric detection for proteomic analyses J Biomol Tech 13 72 84 19498969
    • (2002) J Biomol Tech , vol.13 , pp. 72-84
    • Van Pelt, C.1    Zhang, S.2    Henion, J.3
  • 29
    • 34547595546 scopus 로고    scopus 로고
    • ProSight PTM 2.0: Improved protein identification and characterization for top down mass spectrometry
    • 10.1093/nar/gkm371
    • L Zamdborg RD LeDuc KJ Glowacz YB Kim V Viswanathan IT Spaulding, et al. 2007 ProSight PTM 2.0: improved protein identification and characterization for top down mass spectrometry Nucleic Acids Res 35 W706 W701 10.1093/nar/gkm371
    • (2007) Nucleic Acids Res , vol.35
    • Zamdborg, L.1    Leduc, R.D.2    Glowacz, K.J.3    Kim, Y.B.4    Viswanathan, V.5    Spaulding, I.T.6


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