메뉴 건너뛰기




Volumn 109, Issue , 2015, Pages 52-61

High resolution separation of recombinant monoclonal antibodies by size-exclusion ultra-high performance liquid chromatography (SE-UHPLC)

Author keywords

High pressure; Monoclonal antibodies; SE UHPLC; SEC; Theoretical plates

Indexed keywords

ABCIXIMAB; IMMUNOGLOBULIN F(AB) FRAGMENT; MONOCLONAL ANTIBODY; RECOMBINANT PROTEIN;

EID: 84924270605     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2015.02.032     Document Type: Article
Times cited : (41)

References (25)
  • 1
    • 84892590856 scopus 로고    scopus 로고
    • Antibodies to watch in 2014
    • Reichert J.M. Antibodies to watch in 2014. mAbs 2014, 6:5-14.
    • (2014) mAbs , vol.6 , pp. 5-14
    • Reichert, J.M.1
  • 4
    • 78650543555 scopus 로고    scopus 로고
    • Impact of product-related factors on immunogenocity of biotherapeutics
    • Singh S.K. Impact of product-related factors on immunogenocity of biotherapeutics. J. Pharm. Sci. 2011, 100:354-387.
    • (2011) J. Pharm. Sci. , vol.100 , pp. 354-387
    • Singh, S.K.1
  • 5
    • 84862212634 scopus 로고    scopus 로고
    • Quality attributes of recombinant therapeutic proteins: an assessment of impact on safety and efficacy as part of a quality by design development approach
    • Eon-Duval A., Broly H., Gleixner R. Quality attributes of recombinant therapeutic proteins: an assessment of impact on safety and efficacy as part of a quality by design development approach. Biotechnol. Prog. 2012, 28:608-622.
    • (2012) Biotechnol. Prog. , vol.28 , pp. 608-622
    • Eon-Duval, A.1    Broly, H.2    Gleixner, R.3
  • 6
    • 84870952537 scopus 로고    scopus 로고
    • Size-exclusion chromatography for the analysis of protein biotherapeutics and their aggregates
    • Hong P., Koza S., Bouvier E.S.P. Size-exclusion chromatography for the analysis of protein biotherapeutics and their aggregates. J. Liq. Chromatogr. Relat. Technol. 2012, 35:2923-2950.
    • (2012) J. Liq. Chromatogr. Relat. Technol. , vol.35 , pp. 2923-2950
    • Hong, P.1    Koza, S.2    Bouvier, E.S.P.3
  • 7
    • 84908606572 scopus 로고    scopus 로고
    • Theory and practice of size exclusion chromatography for the analysis of protein aggregates
    • Fekete S., Beck A., Veuthey J.-L., Guillarme D. Theory and practice of size exclusion chromatography for the analysis of protein aggregates. J. Pharm. Biomed. Anal. 2014, 101:161-173.
    • (2014) J. Pharm. Biomed. Anal. , vol.101 , pp. 161-173
    • Fekete, S.1    Beck, A.2    Veuthey, J.-L.3    Guillarme, D.4
  • 8
    • 8344224534 scopus 로고    scopus 로고
    • Characterizing Biological Products and Assessing Comparability following manufacturing changes
    • Chirino A.J., Mire-Sluis A. Characterizing Biological Products and Assessing Comparability following manufacturing changes. Nat. Biotechnol. 2004, 22:1383-1391.
    • (2004) Nat. Biotechnol. , vol.22 , pp. 1383-1391
    • Chirino, A.J.1    Mire-Sluis, A.2
  • 9
    • 77951267552 scopus 로고    scopus 로고
    • Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: essential need to use orthogonal methods to assure the quality of therapeutic protein products
    • Carpenter J.F., Randolph T.W., Jiskoot W., Crommelin D.J.A., Middaugh C.R., Winter G. Potential inaccurate quantitation and sizing of protein aggregates by size exclusion chromatography: essential need to use orthogonal methods to assure the quality of therapeutic protein products. J. Pharm. Sci. 2010, 99:2200-2208.
    • (2010) J. Pharm. Sci. , vol.99 , pp. 2200-2208
    • Carpenter, J.F.1    Randolph, T.W.2    Jiskoot, W.3    Crommelin, D.J.A.4    Middaugh, C.R.5    Winter, G.6
  • 10
    • 77949807386 scopus 로고    scopus 로고
    • The critical role of mobile phase composition in size exclusion chromatography of protein pharmaceuticals
    • Arakawa T., Ejima D., Li T., Philo J.S. The critical role of mobile phase composition in size exclusion chromatography of protein pharmaceuticals. J. Pharm. Sci. 2010, 99:1674-1692.
    • (2010) J. Pharm. Sci. , vol.99 , pp. 1674-1692
    • Arakawa, T.1    Ejima, D.2    Li, T.3    Philo, J.S.4
  • 11
    • 84860259177 scopus 로고    scopus 로고
    • Quantitative impurity analysis of monoclonal antibody size heterogeneity by CE-LIF: example of development and validation through a quality-by-design framework
    • Michels D.A., Parker M., Salas-Solano O. Quantitative impurity analysis of monoclonal antibody size heterogeneity by CE-LIF: example of development and validation through a quality-by-design framework. Electrophoresis 2012, 33:815-826.
    • (2012) Electrophoresis , vol.33 , pp. 815-826
    • Michels, D.A.1    Parker, M.2    Salas-Solano, O.3
  • 12
    • 84867199315 scopus 로고    scopus 로고
    • On-line coupling of size exclusion chromatography with mixed-mode liquid chromatography for comprehensive profiling of biopharmaceutical drug product
    • He Y., Friese O.V., Schlittler M.R., Wang Q., Yang X., Bass L.A., Jones M.T. On-line coupling of size exclusion chromatography with mixed-mode liquid chromatography for comprehensive profiling of biopharmaceutical drug product. J. Chromatogr. A 2012, 1262:122-129.
    • (2012) J. Chromatogr. A , vol.1262 , pp. 122-129
    • He, Y.1    Friese, O.V.2    Schlittler, M.R.3    Wang, Q.4    Yang, X.5    Bass, L.A.6    Jones, M.T.7
  • 13
    • 34250662668 scopus 로고    scopus 로고
    • Determination of tryptophan oxidation of monoclonal antibody by reversed phase high performance liquid chromatography
    • Yang J., Wang S., Liu J., Raghani A. Determination of tryptophan oxidation of monoclonal antibody by reversed phase high performance liquid chromatography. J. Chromatogr. A 2007, 1156:174-182.
    • (2007) J. Chromatogr. A , vol.1156 , pp. 174-182
    • Yang, J.1    Wang, S.2    Liu, J.3    Raghani, A.4
  • 14
    • 84872267390 scopus 로고    scopus 로고
    • Facile method of quantification for oxidized tryptophan degradants of monoclonal antibody by mixed mode ultra performance liquid chromatography
    • Wong C., Strachan-Mills C., Burman S. Facile method of quantification for oxidized tryptophan degradants of monoclonal antibody by mixed mode ultra performance liquid chromatography. J. Chromatogr. A 2012, 1270:153-161.
    • (2012) J. Chromatogr. A , vol.1270 , pp. 153-161
    • Wong, C.1    Strachan-Mills, C.2    Burman, S.3
  • 15
    • 84875275370 scopus 로고    scopus 로고
    • Critical evaluation of fast size exclusion chromatographic separations of protein aggregates, applying sub-2μm particles
    • Fekete S., Ganzler K., Guillarme D. Critical evaluation of fast size exclusion chromatographic separations of protein aggregates, applying sub-2μm particles. J. Pharm. Biomed. Anal. 2013, 78-79:141-149.
    • (2013) J. Pharm. Biomed. Anal. , pp. 141-149
    • Fekete, S.1    Ganzler, K.2    Guillarme, D.3
  • 16
    • 81855164598 scopus 로고    scopus 로고
    • A sub-two minutes method for monoclonal antibody-aggregate quantification using parallel interlaced size exclusion high performance liquid chromatography
    • Diederich P., Hansen S.K., Oelmeier S.A., Stolzenberger B., Hubbuch J. A sub-two minutes method for monoclonal antibody-aggregate quantification using parallel interlaced size exclusion high performance liquid chromatography. J. Chromatogr. A 2011, 1218:9010-9018.
    • (2011) J. Chromatogr. A , vol.1218 , pp. 9010-9018
    • Diederich, P.1    Hansen, S.K.2    Oelmeier, S.A.3    Stolzenberger, B.4    Hubbuch, J.5
  • 17
    • 79953237219 scopus 로고    scopus 로고
    • Ultra-High-Pressure LC. (UHPLC) for therapeutic protein characterization
    • Jeong J., Zhang T., Zhang J., Kao Y.H. Ultra-High-Pressure LC. (UHPLC) for therapeutic protein characterization. Am. Pharm. Rev. 2011, 14:44.
    • (2011) Am. Pharm. Rev. , vol.14 , pp. 44
    • Jeong, J.1    Zhang, T.2    Zhang, J.3    Kao, Y.H.4
  • 18
    • 84924249335 scopus 로고    scopus 로고
    • A high throughput ultra performance size exclusion chromatography assay for the analysis of aggregates and fragments of monoclonal antibodies
    • Mou X., Yang X., Li H., Ambrogelly A., Pollard D.J. A high throughput ultra performance size exclusion chromatography assay for the analysis of aggregates and fragments of monoclonal antibodies. Pharm. Bioprocess. 2014, 2:141-156.
    • (2014) Pharm. Bioprocess. , vol.2 , pp. 141-156
    • Mou, X.1    Yang, X.2    Li, H.3    Ambrogelly, A.4    Pollard, D.J.5
  • 19
    • 80054970831 scopus 로고    scopus 로고
    • On-line characterization of monoclonal antibody variants by liquid chromatography-mass spectrometry operating in a two-dimensional format
    • Alvarez M., Tremintin G., Wang J., Eng M., Kao Y.-H., Jeong J., Ling V.T., Borisov O.V. On-line characterization of monoclonal antibody variants by liquid chromatography-mass spectrometry operating in a two-dimensional format. Anal. Biochem. 2011, 419:17-25.
    • (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    Ling, V.T.7    Borisov, O.V.8
  • 22
    • 14744289246 scopus 로고    scopus 로고
    • Non-enzymatic hinge region fragmentation of antibodies in solution
    • Cordoba A.J., Shyong B.-J., Breen D., Harris R.J. Non-enzymatic hinge region fragmentation of antibodies in solution. J. Chromatogr. B 2005, 818:115-121.
    • (2005) J. Chromatogr. B , vol.818 , pp. 115-121
    • Cordoba, A.J.1    Shyong, B.-J.2    Breen, D.3    Harris, R.J.4
  • 23
    • 67349280131 scopus 로고    scopus 로고
    • Elevated cleavage of human immunoglobulin gamma molecules containing a lambda light chain mediated by iron and histidine
    • Ouellette D., Alessandri L., Piparia R., Aikhoje A., Chin A., Radziejewski C., Correia I. Elevated cleavage of human immunoglobulin gamma molecules containing a lambda light chain mediated by iron and histidine. Anal. Biochem. 2009, 389:107-117.
    • (2009) Anal. Biochem. , vol.389 , pp. 107-117
    • Ouellette, D.1    Alessandri, L.2    Piparia, R.3    Aikhoje, A.4    Chin, A.5    Radziejewski, C.6    Correia, I.7
  • 24
    • 34250182367 scopus 로고    scopus 로고
    • Beta-elimination and peptide bond hydrolysis: two distinct mechanisms of human IgG1 hinge fragmentation upon storage
    • Cohen S.L., Price C., Vlasak J. Beta-elimination and peptide bond hydrolysis: two distinct mechanisms of human IgG1 hinge fragmentation upon storage. J. Am. Chem. Soc. 2007, 129:6976-6977.
    • (2007) J. Am. Chem. Soc. , vol.129 , pp. 6976-6977
    • Cohen, S.L.1    Price, C.2    Vlasak, J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.