메뉴 건너뛰기




Volumn 105, Issue 2, 2016, Pages 417-430

Immunogenicity of Therapeutic Protein Aggregates

Author keywords

immune response; physicochemical properties; protein aggregation; proteins; regulatory science

Indexed keywords

DRUG ANTIBODY; HUMAN GROWTH HORMONE; HUMAN IMMUNOGLOBULIN; MONOCLONAL ANTIBODY; PROTEIN AGGREGATE; RECOMBINANT ERYTHROPOIETIN; CYTOKINE;

EID: 84964494989     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1016/j.xphs.2015.11.002     Document Type: Review
Times cited : (408)

References (105)
  • 1
    • 0141567459 scopus 로고    scopus 로고
    • Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation
    • E.Y. Chi, S. Krishnan, T.W. Randolph, and J.F. Carpenter Physical stability of proteins in aqueous solution: mechanism and driving forces in nonnative protein aggregation Pharm Res 20 9 2003 1325 1336
    • (2003) Pharm Res , vol.20 , Issue.9 , pp. 1325-1336
    • Chi, E.Y.1    Krishnan, S.2    Randolph, T.W.3    Carpenter, J.F.4
  • 2
    • 36749040335 scopus 로고    scopus 로고
    • Non-native protein aggregation kinetics
    • C.J. Roberts Non-native protein aggregation kinetics Biotechnol Bioeng 98 5 2007 927 938
    • (2007) Biotechnol Bioeng , vol.98 , Issue.5 , pp. 927-938
    • Roberts, C.J.1
  • 3
    • 68949085124 scopus 로고    scopus 로고
    • Protein aggregation: Pathways, induction factors and analysis
    • H.C. Mahler, W. Friess, U. Grauschopf, and S. Kiese Protein aggregation: pathways, induction factors and analysis J Pharm Sci 98 9 2009 2909 2934
    • (2009) J Pharm Sci , vol.98 , Issue.9 , pp. 2909-2934
    • Mahler, H.C.1    Friess, W.2    Grauschopf, U.3    Kiese, S.4
  • 4
    • 84921730324 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Accessed January 4, 2016
    • U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. Guidance for industry: immunogenicity assessment for therapeutic protein products. 2014. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm338856.pdf. Accessed January 4, 2016.
    • (2014) Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products
  • 5
    • 33748041958 scopus 로고    scopus 로고
    • Effects of protein aggregates: An immunologic perspective
    • A.S. Rosenberg Effects of protein aggregates: an immunologic perspective AAPS J 8 3 2006 E501 E507
    • (2006) AAPS J , vol.8 , Issue.3 , pp. E501-E507
    • Rosenberg, A.S.1
  • 6
    • 0031158980 scopus 로고    scopus 로고
    • Correlation of tolerogenicity of a viral antigen with its immunogenicity
    • M.F. Bachmann, T. Fehr, G. Freer, H. Hengartner, and R.M. Zinkernagel Correlation of tolerogenicity of a viral antigen with its immunogenicity J Immunol 158 11 1997 5106 5111
    • (1997) J Immunol , vol.158 , Issue.11 , pp. 5106-5111
    • Bachmann, M.F.1    Fehr, T.2    Freer, G.3    Hengartner, H.4    Zinkernagel, R.M.5
  • 7
    • 0020546049 scopus 로고
    • Studies on the immunogenicity and tolerogenicity of T-independent antigens
    • R.Z. Dintzis, M.H. Middleton, and H.M. Dintzis Studies on the immunogenicity and tolerogenicity of T-independent antigens J Immunol 131 5 1983 2196 2203
    • (1983) J Immunol , vol.131 , Issue.5 , pp. 2196-2203
    • Dintzis, R.Z.1    Middleton, M.H.2    Dintzis, H.M.3
  • 8
    • 77957365624 scopus 로고    scopus 로고
    • Aggregation and immunogenicity of therapeutic proteins
    • W. Wang, C. Roberts, John Wiley & Sons, Inc Hoboken, NJ
    • V. Filipe, A. Hawe, H. Schellekens, and W. Jiskoot Aggregation and immunogenicity of therapeutic proteins W. Wang, C. Roberts, Aggregation of Therapeutic Proteins 2010 John Wiley & Sons, Inc Hoboken, NJ
    • (2010) Aggregation of Therapeutic Proteins
    • Filipe, V.1    Hawe, A.2    Schellekens, H.3    Jiskoot, W.4
  • 9
    • 84861337214 scopus 로고    scopus 로고
    • Immunogenicity of protein aggregates-concerns and realities
    • W. Wang, S.K. Singh, N. Li, M.R. Toler, K.R. King, and S. Nema Immunogenicity of protein aggregates-concerns and realities Int J Pharm 431 1-2 2012 1 11
    • (2012) Int J Pharm , vol.431 , Issue.1-2 , pp. 1-11
    • Wang, W.1    Singh, S.K.2    Li, N.3    Toler, M.R.4    King, K.R.5    Nema, S.6
  • 10
    • 84897869100 scopus 로고    scopus 로고
    • Immunogenicity of therapeutic proteins: Influence of aggregation
    • K.D. Ratanji, J.P. Derrick, R.J. Dearman, and I. Kimber Immunogenicity of therapeutic proteins: influence of aggregation J Immunotoxicol 11 2 2014 99 109
    • (2014) J Immunotoxicol , vol.11 , Issue.2 , pp. 99-109
    • Ratanji, K.D.1    Derrick, J.P.2    Dearman, R.J.3    Kimber, I.4
  • 12
    • 69249215475 scopus 로고    scopus 로고
    • A critical review of analytical methods for subvisible and visible particles
    • L.O. Narhi, Y. Jiang, S. Cao, K. Benedek, and D. Shnek A critical review of analytical methods for subvisible and visible particles Curr Pharm Biotechnol 10 4 2009 373 381
    • (2009) Curr Pharm Biotechnol , vol.10 , Issue.4 , pp. 373-381
    • Narhi, L.O.1    Jiang, Y.2    Cao, S.3    Benedek, K.4    Shnek, D.5
  • 13
    • 69249206868 scopus 로고    scopus 로고
    • A critical review of methods for size characterization of non-particulate protein aggregates
    • J.S. Philo A critical review of methods for size characterization of non-particulate protein aggregates Curr Pharm Biotechnol 10 4 2009 359 372
    • (2009) Curr Pharm Biotechnol , vol.10 , Issue.4 , pp. 359-372
    • Philo, J.S.1
  • 14
    • 84865378494 scopus 로고    scopus 로고
    • Protein particles: What we know and what we do not know
    • D.C. Ripple, and M.N. Dimitrova Protein particles: what we know and what we do not know J Pharm Sci 101 10 2012 3568 3579
    • (2012) J Pharm Sci , vol.101 , Issue.10 , pp. 3568-3579
    • Ripple, D.C.1    Dimitrova, M.N.2
  • 15
    • 84855894631 scopus 로고    scopus 로고
    • Particles in therapeutic protein formulations, Part 1: Overview of analytical methods
    • S. Zölls, R. Tantipolphan, M. Wiggenhorn, and et al. Particles in therapeutic protein formulations, Part 1: overview of analytical methods J Pharm Sci 101 3 2012 914 935
    • (2012) J Pharm Sci , vol.101 , Issue.3 , pp. 914-935
    • Zölls, S.1    Tantipolphan, R.2    Wiggenhorn, M.3
  • 16
    • 37349069999 scopus 로고    scopus 로고
    • Toll-like receptors 2 and 4 mediate Abeta(1-42) activation of the innate immune response in a human monocytic cell line
    • M.L. Udan, D. Ajit, N.R. Crouse, and M.R. Nichols Toll-like receptors 2 and 4 mediate Abeta(1-42) activation of the innate immune response in a human monocytic cell line J Neurochem 104 2 2008 524 533
    • (2008) J Neurochem , vol.104 , Issue.2 , pp. 524-533
    • Udan, M.L.1    Ajit, D.2    Crouse, N.R.3    Nichols, M.R.4
  • 17
    • 84864103186 scopus 로고    scopus 로고
    • Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses
    • M.K. Joubert, M. Hokom, C. Eakin, and et al. Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses J Biol Chem 287 30 2012 25266 25279
    • (2012) J Biol Chem , vol.287 , Issue.30 , pp. 25266-25279
    • Joubert, M.K.1    Hokom, M.2    Eakin, C.3
  • 18
    • 77953669816 scopus 로고    scopus 로고
    • Dimers and multimers of monoclonal IgG1 exhibit higher in vitro binding affinities to Fcgamma receptors
    • Y. Luo, Z. Lu, S.W. Raso, C. Entrican, and B. Tangarone Dimers and multimers of monoclonal IgG1 exhibit higher in vitro binding affinities to Fcgamma receptors MAbs 1 5 2009 491 504
    • (2009) MAbs , vol.1 , Issue.5 , pp. 491-504
    • Luo, Y.1    Lu, Z.2    Raso, S.W.3    Entrican, C.4    Tangarone, B.5
  • 19
    • 0019503503 scopus 로고
    • Increased Fc receptor activity in monocytes from patients with rheumatoid arthritis: A study of monocyte binding and catabolism of soluble aggregates of IgG in vitro
    • S. Katayama, D. Chia, H. Nasu, and D.W. Knutson Increased Fc receptor activity in monocytes from patients with rheumatoid arthritis: a study of monocyte binding and catabolism of soluble aggregates of IgG in vitro J Immunol 127 2 1981 643 647
    • (1981) J Immunol , vol.127 , Issue.2 , pp. 643-647
    • Katayama, S.1    Chia, D.2    Nasu, H.3    Knutson, D.W.4
  • 20
    • 0027468145 scopus 로고
    • The biochemistry and cell biology of antigen processing and presentation
    • R.N. Germain, and D.H. Margulies The biochemistry and cell biology of antigen processing and presentation Annu Rev Immunol 11 1993 403 450
    • (1993) Annu Rev Immunol , vol.11 , pp. 403-450
    • Germain, R.N.1    Margulies, D.H.2
  • 21
    • 84879647283 scopus 로고    scopus 로고
    • How B cells capture, process and present antigens: A crucial role for cell polarity
    • M.I. Yuseff, P. Pierobon, A. Reversat, and A.M. Lennon-Duménil How B cells capture, process and present antigens: a crucial role for cell polarity Nat Rev Immunol 13 7 2013 475 486
    • (2013) Nat Rev Immunol , vol.13 , Issue.7 , pp. 475-486
    • Yuseff, M.I.1    Pierobon, P.2    Reversat, A.3    Lennon-Duménil, A.M.4
  • 22
    • 84898642873 scopus 로고    scopus 로고
    • Aggregation of human recombinant monoclonal antibodies influences the capacity of dendritic cells to stimulate adaptive T-cell responses in vitro
    • V. Rombach-Riegraf, A.C. Karle, B. Wolf, and et al. Aggregation of human recombinant monoclonal antibodies influences the capacity of dendritic cells to stimulate adaptive T-cell responses in vitro PLoS One 9 1 2014 e86322
    • (2014) PLoS One , vol.9 , Issue.1 , pp. e86322
    • Rombach-Riegraf, V.1    Karle, A.C.2    Wolf, B.3
  • 23
    • 84925507517 scopus 로고    scopus 로고
    • Small amounts of sub-visible aggregates enhance the immunogenic potential of monoclonal antibody therapeutics
    • M. Ahmadi, C.J. Bryson, E.A. Cloake, and et al. Small amounts of sub-visible aggregates enhance the immunogenic potential of monoclonal antibody therapeutics Pharm Res 32 4 2015 1383 1394
    • (2015) Pharm Res , vol.32 , Issue.4 , pp. 1383-1394
    • Ahmadi, M.1    Bryson, C.J.2    Cloake, E.A.3
  • 24
    • 0042689324 scopus 로고
    • Molecular determinants of immunogenicity: The immunon model of immune response
    • H.M. Dintzis, R.Z. Dintzis, and B. Vogelstein Molecular determinants of immunogenicity: the immunon model of immune response Proc Natl Acad Sci U S A 73 10 1976 3671 3675
    • (1976) Proc Natl Acad Sci U S A , vol.73 , Issue.10 , pp. 3671-3675
    • Dintzis, H.M.1    Dintzis, R.Z.2    Vogelstein, B.3
  • 26
    • 0029608873 scopus 로고
    • T helper cell-independent neutralizing B cell response against vesicular stomatitis virus: Role of antigen patterns in B cell induction?
    • M.F. Bachmann, H. Hengartner, and R.M. Zinkernagel T helper cell-independent neutralizing B cell response against vesicular stomatitis virus: role of antigen patterns in B cell induction? Eur J Immunol 25 12 1995 3445 3451
    • (1995) Eur J Immunol , vol.25 , Issue.12 , pp. 3445-3451
    • Bachmann, M.F.1    Hengartner, H.2    Zinkernagel, R.M.3
  • 27
    • 0030965840 scopus 로고    scopus 로고
    • Role of repetitive antigen patterns for induction of antibodies against antibodies
    • T. Fehr, M.F. Bachmann, E. Bucher, and et al. Role of repetitive antigen patterns for induction of antibodies against antibodies J Exp Med 185 10 1997 1785 1792
    • (1997) J Exp Med , vol.185 , Issue.10 , pp. 1785-1792
    • Fehr, T.1    Bachmann, M.F.2    Bucher, E.3
  • 28
    • 0033822039 scopus 로고    scopus 로고
    • B-cell activation by T-cell-independent type 2 antigens as an integral part of the humoral immune response to pathogenic microorganisms
    • Q. Vos, A. Lees, Z.Q. Wu, C.M. Snapper, and J.J. Mond B-cell activation by T-cell-independent type 2 antigens as an integral part of the humoral immune response to pathogenic microorganisms Immunol Rev 176 2000 154 170
    • (2000) Immunol Rev , vol.176 , pp. 154-170
    • Vos, Q.1    Lees, A.2    Wu, Z.Q.3    Snapper, C.M.4    Mond, J.J.5
  • 29
    • 77955465885 scopus 로고    scopus 로고
    • Aggregated recombinant human interferon Beta induces antibodies but no memory in immune-tolerant transgenic mice
    • M.M. van Beers, M. Sauerborn, F. Gilli, V. Brinks, H. Schellekens, and W. Jiskoot Aggregated recombinant human interferon Beta induces antibodies but no memory in immune-tolerant transgenic mice Pharm Res 27 9 2010 1812 1824
    • (2010) Pharm Res , vol.27 , Issue.9 , pp. 1812-1824
    • Van Beers, M.M.1    Sauerborn, M.2    Gilli, F.3    Brinks, V.4    Schellekens, H.5    Jiskoot, W.6
  • 30
    • 84876434714 scopus 로고    scopus 로고
    • Antibody response against Betaferon® in immune tolerant mice: Involvement of marginal zone B-cells and CD4+ T-cells and apparent lack of immunological memory
    • M. Sauerborn, M.M. van Beers, W. Jiskoot, and et al. Antibody response against Betaferon® in immune tolerant mice: involvement of marginal zone B-cells and CD4+ T-cells and apparent lack of immunological memory J Clin Immunol 33 1 2013 255 263
    • (2013) J Clin Immunol , vol.33 , Issue.1 , pp. 255-263
    • Sauerborn, M.1    Van Beers, M.M.2    Jiskoot, W.3
  • 31
    • 84922875534 scopus 로고    scopus 로고
    • Development of ADA against recombinant human interferon beta in immune tolerant mice requires rapid recruitment of CD4(+) T cells, induces formation of germinal centers but lacks susceptibility for (most) adjuvants
    • G. Kijanka, M. Sauerborn, L. Boon, H. Schellekens, and V. Brinks Development of ADA against recombinant human interferon beta in immune tolerant mice requires rapid recruitment of CD4(+) T cells, induces formation of germinal centers but lacks susceptibility for (most) adjuvants J Pharm Sci 104 2 2015 396 406
    • (2015) J Pharm Sci , vol.104 , Issue.2 , pp. 396-406
    • Kijanka, G.1    Sauerborn, M.2    Boon, L.3    Schellekens, H.4    Brinks, V.5
  • 32
    • 84890525954 scopus 로고    scopus 로고
    • Recombinant murine growth hormone particles are more immunogenic with intravenous than subcutaneous administration
    • M. Christie, R.M. Torres, R.M. Kedl, T.W. Randolph, and J.F. Carpenter Recombinant murine growth hormone particles are more immunogenic with intravenous than subcutaneous administration J Pharm Sci 103 1 2014 128 139
    • (2014) J Pharm Sci , vol.103 , Issue.1 , pp. 128-139
    • Christie, M.1    Torres, R.M.2    Kedl, R.M.3    Randolph, T.W.4    Carpenter, J.F.5
  • 33
  • 34
    • 84869838281 scopus 로고    scopus 로고
    • Immunogenicity of different stressed IgG monoclonal antibody formulations in immune tolerant transgenic mice
    • V. Filipe, W. Jiskoot, A.H. Basmeleh, A. Halim, H. Schellekens, and V. Brinks Immunogenicity of different stressed IgG monoclonal antibody formulations in immune tolerant transgenic mice MAbs 4 6 2012 740 752
    • (2012) MAbs , vol.4 , Issue.6 , pp. 740-752
    • Filipe, V.1    Jiskoot, W.2    Basmeleh, A.H.3    Halim, A.4    Schellekens, H.5    Brinks, V.6
  • 35
    • 84883811790 scopus 로고    scopus 로고
    • Development of a human antibody tolerant mouse model to assess the immunogenicity risk due to aggregated biotherapeutics
    • V. Bi, V. Jawa, M.K. Joubert, and et al. Development of a human antibody tolerant mouse model to assess the immunogenicity risk due to aggregated biotherapeutics J Pharm Sci 102 10 2013 3545 3555
    • (2013) J Pharm Sci , vol.102 , Issue.10 , pp. 3545-3555
    • Bi, V.1    Jawa, V.2    Joubert, M.K.3
  • 36
    • 84930177962 scopus 로고    scopus 로고
    • The immunogenicity of antibody aggregates in a novel transgenic mouse model
    • J. Bessa, S. Boeckle, H. Beck, and et al. The immunogenicity of antibody aggregates in a novel transgenic mouse model J Pharm Res 32 7 2015 2344 2359
    • (2015) J Pharm Res , vol.32 , Issue.7 , pp. 2344-2359
    • Bessa, J.1    Boeckle, S.2    Beck, H.3
  • 37
    • 84890560538 scopus 로고    scopus 로고
    • Antibody responses in mice to particles formed from adsorption of a murine monoclonal antibody onto glass microparticles
    • M. Shomali, A. Freitag, J. Engert, and et al. Antibody responses in mice to particles formed from adsorption of a murine monoclonal antibody onto glass microparticles J Pharm Sci 103 1 2014 78 89
    • (2014) J Pharm Sci , vol.103 , Issue.1 , pp. 78-89
    • Shomali, M.1    Freitag, A.2    Engert, J.3
  • 38
    • 84926367775 scopus 로고    scopus 로고
    • Investigation of the immunogenicity of different types of aggregates of a murine monoclonal antibody in mice
    • A.J. Freitag, M. Shomali, S. Michalakis, and et al. Investigation of the immunogenicity of different types of aggregates of a murine monoclonal antibody in mice Pharm Res 32 2 2015 430 444
    • (2015) Pharm Res , vol.32 , Issue.2 , pp. 430-444
    • Freitag, A.J.1    Shomali, M.2    Michalakis, S.3
  • 39
    • 84926307589 scopus 로고    scopus 로고
    • Dose levels in particulate-containing formulations impact anti-drug antibody responses to murine monoclonal antibody in mice
    • M. Shomali, S. Tanriverdi, A.J. Freitag, and et al. Dose levels in particulate-containing formulations impact anti-drug antibody responses to murine monoclonal antibody in mice J Pharm Sci 104 5 2015 1610 1621
    • (2015) J Pharm Sci , vol.104 , Issue.5 , pp. 1610-1621
    • Shomali, M.1    Tanriverdi, S.2    Freitag, A.J.3
  • 40
    • 0014427447 scopus 로고
    • Antibody production to aggregated human gamma-G-globulin in acquired hypogammaglobulinemia
    • C.S. Henney, and E.F. Ellis Antibody production to aggregated human gamma-G-globulin in acquired hypogammaglobulinemia N Engl J Med 278 21 1968 1144 1146
    • (1968) N Engl J Med , vol.278 , Issue.21 , pp. 1144-1146
    • Henney, C.S.1    Ellis, E.F.2
  • 41
    • 0000826599 scopus 로고
    • Intravenous administration of human gamma-globulin
    • S. Barandun, P. Kistler, F. Jeunet, and H. Isliker Intravenous administration of human gamma-globulin Vox Sang 7 1962 157 174
    • (1962) Vox Sang , vol.7 , pp. 157-174
    • Barandun, S.1    Kistler, P.2    Jeunet, F.3    Isliker, H.4
  • 42
    • 0018974918 scopus 로고
    • Role of aggregated human growth hormone (hGH) in development of antibodies to hGH
    • W.V. Moore, and P. Leppert Role of aggregated human growth hormone (hGH) in development of antibodies to hGH J Clin Endocrinol Metab 51 4 1980 691 697
    • (1980) J Clin Endocrinol Metab , vol.51 , Issue.4 , pp. 691-697
    • Moore, W.V.1    Leppert, P.2
  • 43
    • 84862644490 scopus 로고    scopus 로고
    • Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity
    • A. Seidl, O. Hainzl, M. Richter, and et al. Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity Pharm Res 29 6 2012 1454 1467
    • (2012) Pharm Res , vol.29 , Issue.6 , pp. 1454-1467
    • Seidl, A.1    Hainzl, O.2    Richter, M.3
  • 44
    • 0030754581 scopus 로고    scopus 로고
    • Clinical investigation of the immunogenicity of interferon-alpha 2a
    • J.C. Ryff Clinical investigation of the immunogenicity of interferon-alpha 2a J Interferon Cytokine Res 17 suppl 1 1997 S29 S33
    • (1997) J Interferon Cytokine Res , vol.17 , pp. S29-S33
    • Ryff, J.C.1
  • 45
    • 0030740864 scopus 로고    scopus 로고
    • Interferon immunogenicity: Preclinical evaluation of interferon-alpha 2a
    • A.V. Palleroni, A. Aglione, M. Labow, and et al. Interferon immunogenicity: preclinical evaluation of interferon-alpha 2a J Interferon Cytokine Res 17 suppl 1 1997 S23 S27
    • (1997) J Interferon Cytokine Res , vol.17 , pp. S23-S27
    • Palleroni, A.V.1    Aglione, A.2    Labow, M.3
  • 46
  • 47
    • 84878149778 scopus 로고    scopus 로고
    • Characterization and quantitation of aggregates and particles in interferon-β products: Potential links between product quality attributes and immunogenicity
    • J.G. Barnard, K. Babcock, and J.F. Carpenter Characterization and quantitation of aggregates and particles in interferon-β products: potential links between product quality attributes and immunogenicity J Pharm Sci 102 3 2013 915 928
    • (2013) J Pharm Sci , vol.102 , Issue.3 , pp. 915-928
    • Barnard, J.G.1    Babcock, K.2    Carpenter, J.F.3
  • 48
    • 84874865609 scopus 로고    scopus 로고
    • Role of hsp90 in systemic lupus erythematosus and its clinical relevance
    • H.D. Shukla, and P.M. Pitha Role of hsp90 in systemic lupus erythematosus and its clinical relevance Autoimmune Dis 2012 2012 728605
    • (2012) Autoimmune Dis , vol.2012 , pp. 728605
    • Shukla, H.D.1    Pitha, P.M.2
  • 49
    • 0037075272 scopus 로고    scopus 로고
    • Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin
    • N. Casadevall, J. Nataf, B. Viron, and et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin N Engl J Med 346 7 2002 469 475
    • (2002) N Engl J Med , vol.346 , Issue.7 , pp. 469-475
    • Casadevall, N.1    Nataf, J.2    Viron, B.3
  • 50
  • 51
    • 0014443608 scopus 로고
    • Adverse reactions following administration of human gamma globulin
    • E.F. Ellis, and C.S. Henney Adverse reactions following administration of human gamma globulin J Allergy 43 1 1969 45 54
    • (1969) J Allergy , vol.43 , Issue.1 , pp. 45-54
    • Ellis, E.F.1    Henney, C.S.2
  • 52
    • 84869431305 scopus 로고    scopus 로고
    • Intravenous immune globulin in autoimmune and inflammatory diseases
    • E.W. Gelfand Intravenous immune globulin in autoimmune and inflammatory diseases N Engl J Med 367 21 2012 2015 2025
    • (2012) N Engl J Med , vol.367 , Issue.21 , pp. 2015-2025
    • Gelfand, E.W.1
  • 53
    • 70449537540 scopus 로고
    • Studies of aggregated gamma-globulin. I. Sedimentation, electrophoretic and anticomplementary properties
    • C.L. Christian Studies of aggregated gamma-globulin. I. Sedimentation, electrophoretic and anticomplementary properties J Immunol 84 1960 112 116
    • (1960) J Immunol , vol.84 , pp. 112-116
    • Christian, C.L.1
  • 54
    • 70449551922 scopus 로고
    • Studies of aggregated gamma-globulin. II. Effect in vivo
    • C.L. Christian Studies of aggregated gamma-globulin. II. Effect in vivo J Immunol 84 1960 117 121
    • (1960) J Immunol , vol.84 , pp. 117-121
    • Christian, C.L.1
  • 55
    • 0014830428 scopus 로고
    • Immunologic responses of graft recipients to antilymphocyte globulin: Effect of prior treatment with aggregate-free gamma globulin
    • M.E. Weksler, G. Bull, G.H. Schwartz, K.H. Stenzel, and A.L. Rubin Immunologic responses of graft recipients to antilymphocyte globulin: effect of prior treatment with aggregate-free gamma globulin J Clin Invest 49 8 1970 1589 1595
    • (1970) J Clin Invest , vol.49 , Issue.8 , pp. 1589-1595
    • Weksler, M.E.1    Bull, G.2    Schwartz, G.H.3    Stenzel, K.H.4    Rubin, A.L.5
  • 56
    • 0015991075 scopus 로고
    • Restoration of growth by human growth hormone (Roos) in hypopituitary dwarfs immunized by other human growth hormone preparations: Clinical and immunological studies
    • L.E. Underwood, S.J. Voina, and J.J. Van Wyk Restoration of growth by human growth hormone (Roos) in hypopituitary dwarfs immunized by other human growth hormone preparations: clinical and immunological studies J Clin Endocrinol Metab 38 2 1974 288 297
    • (1974) J Clin Endocrinol Metab , vol.38 , Issue.2 , pp. 288-297
    • Underwood, L.E.1    Voina, S.J.2    Van Wyk, J.J.3
  • 57
    • 36049007201 scopus 로고    scopus 로고
    • Recombinant EPO production - Points the nephrologist should know
    • W. Jelkmann Recombinant EPO production - points the nephrologist should know Nephrol Dial Transplant 22 10 2007 2749 2753
    • (2007) Nephrol Dial Transplant , vol.22 , Issue.10 , pp. 2749-2753
    • Jelkmann, W.1
  • 58
    • 19044381985 scopus 로고    scopus 로고
    • Antibody-mediated pure red cell aplasia (PRCA): Epidemiology, immunogenicity and risks
    • I.C. Macdougall Antibody-mediated pure red cell aplasia (PRCA): epidemiology, immunogenicity and risks Nephrol Dial Transplant 20 suppl 4 2005 iv9 iv15
    • (2005) Nephrol Dial Transplant , vol.20 , pp. iv9-iv15
    • MacDougall, I.C.1
  • 59
    • 29944432284 scopus 로고    scopus 로고
    • Intravenous immunoglobulin: Adverse effects and safe administration
    • H. Orbach, U. Katz, Y. Sherer, and Y. Shoenfeld Intravenous immunoglobulin: adverse effects and safe administration Clin Rev Allergy Immunol 29 3 2005 173 184
    • (2005) Clin Rev Allergy Immunol , vol.29 , Issue.3 , pp. 173-184
    • Orbach, H.1    Katz, U.2    Sherer, Y.3    Shoenfeld, Y.4
  • 60
    • 77957367160 scopus 로고    scopus 로고
    • On the role of aggregates in the immunogenicity of recombinant human interferon beta in patients with multiple sclerosis
    • M.M. van Beers, W. Jiskoot, and H. Schellekens On the role of aggregates in the immunogenicity of recombinant human interferon beta in patients with multiple sclerosis J Interferon Cytokine Res 30 10 2010 767 775
    • (2010) J Interferon Cytokine Res , vol.30 , Issue.10 , pp. 767-775
    • Van Beers, M.M.1    Jiskoot, W.2    Schellekens, H.3
  • 61
    • 23444462074 scopus 로고
    • Interferon alfa-2a as compared with conventional chemotherapy for the treatment of chronic myeloid leukemia
    • TICSGoCM Interferon alfa-2a as compared with conventional chemotherapy for the treatment of chronic myeloid leukemia N Engl J Med 330 12 1994 820 825
    • (1994) N Engl J Med , vol.330 , Issue.12 , pp. 820-825
  • 62
    • 0030803840 scopus 로고    scopus 로고
    • Interferon immunogenicity: Technical evaluation of interferon-alpha 2a
    • E. Hochuli Interferon immunogenicity: technical evaluation of interferon-alpha 2a J Interferon Cytokine Res 17 suppl 1 1997 S15 S21
    • (1997) J Interferon Cytokine Res , vol.17 , pp. S15-S21
    • Hochuli, E.1
  • 63
    • 79960128166 scopus 로고    scopus 로고
    • Classification and characterization of therapeutic antibody aggregates
    • M.K. Joubert, Q. Luo, Y. Nashed-Samuel, J. Wypych, and L.O. Narhi Classification and characterization of therapeutic antibody aggregates J Biol Chem 286 28 2011 25118 25133
    • (2011) J Biol Chem , vol.286 , Issue.28 , pp. 25118-25133
    • Joubert, M.K.1    Luo, Q.2    Nashed-Samuel, Y.3    Wypych, J.4    Narhi, L.O.5
  • 64
    • 0030856842 scopus 로고    scopus 로고
    • Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-alpha) in normal and transgenic mice
    • A. Braun, L. Kwee, M.A. Labow, and J. Alsenz Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-alpha) in normal and transgenic mice Pharm Res 14 10 1997 1472 1478
    • (1997) Pharm Res , vol.14 , Issue.10 , pp. 1472-1478
    • Braun, A.1    Kwee, L.2    Labow, M.A.3    Alsenz, J.4
  • 65
    • 29244462955 scopus 로고    scopus 로고
    • Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b
    • S. Hermeling, L. Aranha, J.M. Damen, and et al. Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b Pharm Res 22 12 2005 1997 2006
    • (2005) Pharm Res , vol.22 , Issue.12 , pp. 1997-2006
    • Hermeling, S.1    Aranha, L.2    Damen, J.M.3
  • 66
    • 33646546740 scopus 로고    scopus 로고
    • Antibody response to aggregated human interferon alpha2b in wild-type and transgenic immune tolerant mice depends on type and level of aggregation
    • S. Hermeling, H. Schellekens, C. Maas, M.F. Gebbink, D.J. Crommelin, and W. Jiskoot Antibody response to aggregated human interferon alpha2b in wild-type and transgenic immune tolerant mice depends on type and level of aggregation J Pharm Sci 95 5 2006 1084 1096
    • (2006) J Pharm Sci , vol.95 , Issue.5 , pp. 1084-1096
    • Hermeling, S.1    Schellekens, H.2    Maas, C.3    Gebbink, M.F.4    Crommelin, D.J.5    Jiskoot, W.6
  • 67
    • 68949135230 scopus 로고    scopus 로고
    • Immunogenicity of aggregates of recombinant human growth hormone in mouse models
    • A.H. Fradkin, J.F. Carpenter, and T.W. Randolph Immunogenicity of aggregates of recombinant human growth hormone in mouse models J Pharm Sci 98 9 2009 3247 3264
    • (2009) J Pharm Sci , vol.98 , Issue.9 , pp. 3247-3264
    • Fradkin, A.H.1    Carpenter, J.F.2    Randolph, T.W.3
  • 68
    • 32644434554 scopus 로고    scopus 로고
    • Influence of aggregation on immunogenicity of recombinant human Factor VIII in hemophilia A mice
    • V.S. Purohit, C.R. Middaugh, and S.V. Balasubramanian Influence of aggregation on immunogenicity of recombinant human Factor VIII in hemophilia A mice J Pharm Sci 95 2 2006 358 371
    • (2006) J Pharm Sci , vol.95 , Issue.2 , pp. 358-371
    • Purohit, V.S.1    Middaugh, C.R.2    Balasubramanian, S.V.3
  • 69
    • 84859758529 scopus 로고    scopus 로고
    • Native-like aggregates of factor VIII are immunogenic in von Willebrand factor deficient and hemophilia a mice
    • D.S. Pisal, M.P. Kosloski, C.R. Middaugh, R.B. Bankert, and S.V. Balu-Iyer Native-like aggregates of factor VIII are immunogenic in von Willebrand factor deficient and hemophilia a mice J Pharm Sci 101 6 2012 2055 2065
    • (2012) J Pharm Sci , vol.101 , Issue.6 , pp. 2055-2065
    • Pisal, D.S.1    Kosloski, M.P.2    Middaugh, C.R.3    Bankert, R.B.4    Balu-Iyer, S.V.5
  • 70
    • 84897979786 scopus 로고    scopus 로고
    • Development of a transgenic mouse model to study the immunogenicity of recombinant human insulin
    • R. Torosantucci, V. Brinks, G. Kijanka, and et al. Development of a transgenic mouse model to study the immunogenicity of recombinant human insulin J Pharm Sci 103 5 2014 1367 1374
    • (2014) J Pharm Sci , vol.103 , Issue.5 , pp. 1367-1374
    • Torosantucci, R.1    Brinks, V.2    Kijanka, G.3
  • 71
    • 0242553054 scopus 로고
    • Sensitization to denatured autologous gamma globulin
    • R.T. McCluskey, F. Miller, and B. Benacerraf Sensitization to denatured autologous gamma globulin J Exp Med 115 1 1962 253 273
    • (1962) J Exp Med , vol.115 , Issue.1 , pp. 253-273
    • McCluskey, R.T.1    Miller, F.2    Benacerraf, B.3
  • 72
    • 78651193582 scopus 로고
    • The antigenicity of aggregated and aggregate-free human gamma-globulin for rabbits
    • C.E. Biro, and G. Garcia The antigenicity of aggregated and aggregate-free human gamma-globulin for rabbits Immunology 8 1965 411 419
    • (1965) Immunology , vol.8 , pp. 411-419
    • Biro, C.E.1    Garcia, G.2
  • 73
    • 0000017701 scopus 로고
    • Specific inhibition of antibody production. I. Protein-over loading paralysis
    • D.W. Dresser Specific inhibition of antibody production. I. Protein-over loading paralysis Immunology 5 1962 161 168
    • (1962) Immunology , vol.5 , pp. 161-168
    • Dresser, D.W.1
  • 74
    • 0642282753 scopus 로고
    • Tolerance to a protein antigen in adult mice and the effect of nonspecific factors
    • H.N. Claman Tolerance to a protein antigen in adult mice and the effect of nonspecific factors J Immunol 91 1963 833 839
    • (1963) J Immunol , vol.91 , pp. 833-839
    • Claman, H.N.1
  • 75
    • 0013990167 scopus 로고
    • The role of soluble aggregates in the primary immune response of mice to human gamma globulin
    • C.N. Gamble The role of soluble aggregates in the primary immune response of mice to human gamma globulin Int Arch Allergy Appl Immunol 30 5 1966 446 455
    • (1966) Int Arch Allergy Appl Immunol , vol.30 , Issue.5 , pp. 446-455
    • Gamble, C.N.1
  • 76
    • 0014251022 scopus 로고
    • Immunogenic potency of human gamma-globulin in mice
    • A. Sassen, E.H. Perkins, and R.A. Brown Immunogenic potency of human gamma-globulin in mice Immunology 14 2 1968 247 256
    • (1968) Immunology , vol.14 , Issue.2 , pp. 247-256
    • Sassen, A.1    Perkins, E.H.2    Brown, R.A.3
  • 77
    • 80053289158 scopus 로고    scopus 로고
    • Glass particles as an adjuvant: A model for adverse immunogenicity of therapeutic proteins
    • A.H. Fradkin, J.F. Carpenter, and T.W. Randolph Glass particles as an adjuvant: a model for adverse immunogenicity of therapeutic proteins J Pharm Sci 100 11 2011 4953 4964
    • (2011) J Pharm Sci , vol.100 , Issue.11 , pp. 4953-4964
    • Fradkin, A.H.1    Carpenter, J.F.2    Randolph, T.W.3
  • 78
    • 79960135244 scopus 로고    scopus 로고
    • Chemical modifications in therapeutic protein aggregates generated under different stress conditions
    • Q. Luo, M.K. Joubert, R. Stevenson, R.R. Ketchem, L.O. Narhi, and J. Wypych Chemical modifications in therapeutic protein aggregates generated under different stress conditions J Biol Chem 286 28 2011 25134 25144
    • (2011) J Biol Chem , vol.286 , Issue.28 , pp. 25134-25144
    • Luo, Q.1    Joubert, M.K.2    Stevenson, R.3    Ketchem, R.R.4    Narhi, L.O.5    Wypych, J.6
  • 79
    • 84903208792 scopus 로고    scopus 로고
    • T-cell-dependent antibody responses in the rat: Forms and sources of keyhole limpet hemocyanin matter
    • H. Lebrec, M.B. Hock, J.S. Sundsmo, and et al. T-cell-dependent antibody responses in the rat: forms and sources of keyhole limpet hemocyanin matter J Immunotoxicol 11 3 2014 213 221
    • (2014) J Immunotoxicol , vol.11 , Issue.3 , pp. 213-221
    • Lebrec, H.1    Hock, M.B.2    Sundsmo, J.S.3
  • 80
    • 84891630467 scopus 로고    scopus 로고
    • In vivo fluorescence imaging of IgG1 aggregates after subcutaneous and intravenous injection in mice
    • V. Filipe, I. Que, J.F. Carpenter, C. Löwik, and W. Jiskoot In vivo fluorescence imaging of IgG1 aggregates after subcutaneous and intravenous injection in mice Pharm Res 31 1 2014 216 227
    • (2014) Pharm Res , vol.31 , Issue.1 , pp. 216-227
    • Filipe, V.1    Que, I.2    Carpenter, J.F.3    Löwik, C.4    Jiskoot, W.5
  • 81
    • 21244436416 scopus 로고    scopus 로고
    • Development of a transgenic mouse model immune tolerant for human interferon Beta
    • S. Hermeling, W. Jiskoot, D. Crommelin, C. Bornaes, and H. Schellekens Development of a transgenic mouse model immune tolerant for human interferon Beta Pharm Res 22 6 2005 847 851
    • (2005) Pharm Res , vol.22 , Issue.6 , pp. 847-851
    • Hermeling, S.1    Jiskoot, W.2    Crommelin, D.3    Bornaes, C.4    Schellekens, H.5
  • 82
    • 80054743161 scopus 로고    scopus 로고
    • Oxidized and aggregated recombinant human interferon beta is immunogenic in human interferon beta transgenic mice
    • M.M. van Beers, M. Sauerborn, F. Gilli, V. Brinks, H. Schellekens, and W. Jiskoot Oxidized and aggregated recombinant human interferon beta is immunogenic in human interferon beta transgenic mice Pharm Res 28 10 2011 2393 2402
    • (2011) Pharm Res , vol.28 , Issue.10 , pp. 2393-2402
    • Van Beers, M.M.1    Sauerborn, M.2    Gilli, F.3    Brinks, V.4    Schellekens, H.5    Jiskoot, W.6
  • 83
    • 82255175808 scopus 로고    scopus 로고
    • Immunogenicity of recombinant human interferon beta interacting with particles of glass, metal, and polystyrene
    • M.M. Van Beers, F. Gilli, H. Schellekens, T.W. Randolph, and W. Jiskoot Immunogenicity of recombinant human interferon beta interacting with particles of glass, metal, and polystyrene J Pharm Sci 101 1 2012 187 199
    • (2012) J Pharm Sci , vol.101 , Issue.1 , pp. 187-199
    • Van Beers, M.M.1    Gilli, F.2    Schellekens, H.3    Randolph, T.W.4    Jiskoot, W.5
  • 84
    • 59449097322 scopus 로고    scopus 로고
    • How we treat a hemophilia A patient with a factor VIII inhibitor
    • C.L. Kempton, and G.C. White How we treat a hemophilia A patient with a factor VIII inhibitor Blood 113 1 2009 11 17
    • (2009) Blood , vol.113 , Issue.1 , pp. 11-17
    • Kempton, C.L.1    White, G.C.2
  • 85
    • 84888022850 scopus 로고    scopus 로고
    • T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation
    • V. Jawa, L.P. Cousens, M. Awwad, E. Wakshull, H. Kropshofer, and A.S. De Groot T-cell dependent immunogenicity of protein therapeutics: preclinical assessment and mitigation Clin Immunol 149 3 2013 534 555
    • (2013) Clin Immunol , vol.149 , Issue.3 , pp. 534-555
    • Jawa, V.1    Cousens, L.P.2    Awwad, M.3    Wakshull, E.4    Kropshofer, H.5    De Groot, A.S.6
  • 86
    • 0019988012 scopus 로고
    • Degradation of soluble immunoglobulin aggregates in vitro by monocytes from normal subjects and from patients with systemic lupus erythematosus
    • M.R. Daha, E.S.L.A. van, H.M. Hazevoet, and A. Kijlstra Degradation of soluble immunoglobulin aggregates in vitro by monocytes from normal subjects and from patients with systemic lupus erythematosus Scand J Immunol 16 2 1982 117 122
    • (1982) Scand J Immunol , vol.16 , Issue.2 , pp. 117-122
    • Daha, M.R.1    Van, E.S.L.A.2    Hazevoet, H.M.3    Kijlstra, A.4
  • 87
    • 0025376439 scopus 로고
    • Aggregated immunoglobulin and Fc fragment of IgG induce IL-6 release from human monocytes
    • Z.D. Ling, H.J. Ziltener, B.T. Webb, and D.S. Matheson Aggregated immunoglobulin and Fc fragment of IgG induce IL-6 release from human monocytes Cell Immunol 129 1 1990 95 103
    • (1990) Cell Immunol , vol.129 , Issue.1 , pp. 95-103
    • Ling, Z.D.1    Ziltener, H.J.2    Webb, B.T.3    Matheson, D.S.4
  • 88
    • 0034651748 scopus 로고    scopus 로고
    • Visualization of beta-amyloid peptide (Abeta) phagocytosis by human mononuclear phagocytes: Dependency on Abeta aggregate size
    • R.B. Weltzien, and J.S. Pachter Visualization of beta-amyloid peptide (Abeta) phagocytosis by human mononuclear phagocytes: dependency on Abeta aggregate size J Neurosci Res 59 4 2000 522 527
    • (2000) J Neurosci Res , vol.59 , Issue.4 , pp. 522-527
    • Weltzien, R.B.1    Pachter, J.S.2
  • 89
    • 84926661231 scopus 로고    scopus 로고
    • Physical characterization and in vitro biological impact of highly aggregated antibodies separated into size-enriched populations by fluorescence-activated cell sorting
    • S. Telikepalli, H.E. Shinogle, P.S. Thapa, and et al. Physical characterization and in vitro biological impact of highly aggregated antibodies separated into size-enriched populations by fluorescence-activated cell sorting J Pharm Sci 104 5 2015 1575 1591
    • (2015) J Pharm Sci , vol.104 , Issue.5 , pp. 1575-1591
    • Telikepalli, S.1    Shinogle, H.E.2    Thapa, P.S.3
  • 90
    • 54849437047 scopus 로고    scopus 로고
    • Prediction of immunogenicity: In silico paradigms, ex vivo and in vivo correlates
    • A.S. De Groot, J. McMurry, and L. Moise Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates Curr Opin Pharmacol 8 5 2008 620 626
    • (2008) Curr Opin Pharmacol , vol.8 , Issue.5 , pp. 620-626
    • De Groot, A.S.1    McMurry, J.2    Moise, L.3
  • 91
    • 80054949314 scopus 로고    scopus 로고
    • Aggregation in protein-based biotherapeutics: Computational studies and tools to identify aggregation-prone regions
    • N.J. Agrawal, S. Kumar, X. Wang, B. Helk, S.K. Singh, and B.L. Trout Aggregation in protein-based biotherapeutics: computational studies and tools to identify aggregation-prone regions J Pharm Sci 100 12 2011 5081 5095
    • (2011) J Pharm Sci , vol.100 , Issue.12 , pp. 5081-5095
    • Agrawal, N.J.1    Kumar, S.2    Wang, X.3    Helk, B.4    Singh, S.K.5    Trout, B.L.6
  • 93
    • 77952471578 scopus 로고    scopus 로고
    • Predictive tools for stabilization of therapeutic proteins
    • V. Voynov, N. Chennamsetty, V. Kayser, B. Helk, and B.L. Trout Predictive tools for stabilization of therapeutic proteins MAbs 1 6 2009 580 582
    • (2009) MAbs , vol.1 , Issue.6 , pp. 580-582
    • Voynov, V.1    Chennamsetty, N.2    Kayser, V.3    Helk, B.4    Trout, B.L.5
  • 95
    • 45749102914 scopus 로고    scopus 로고
    • The Zyggregator method for predicting protein aggregation propensities
    • G.G. Tartaglia, and M. Vendruscolo The Zyggregator method for predicting protein aggregation propensities Chem Soc Rev 37 7 2008 1395 1401
    • (2008) Chem Soc Rev , vol.37 , Issue.7 , pp. 1395-1401
    • Tartaglia, G.G.1    Vendruscolo, M.2
  • 96
    • 36248964819 scopus 로고    scopus 로고
    • The PASTA server for protein aggregation prediction
    • A. Trovato, F. Seno, and S.C. Tosatto The PASTA server for protein aggregation prediction Protein Eng Des Sel 20 10 2007 521 523
    • (2007) Protein Eng des Sel , vol.20 , Issue.10 , pp. 521-523
    • Trovato, A.1    Seno, F.2    Tosatto, S.C.3
  • 97
    • 84904786762 scopus 로고    scopus 로고
    • PASTA 2.0: An improved server for protein aggregation prediction
    • I. Walsh, F. Seno, S.C. Tosatto, and A. Trovato PASTA 2.0: an improved server for protein aggregation prediction Nucleic Acids Res 42 Web Server issue 2014 W301 W307
    • (2014) Nucleic Acids Res , vol.42 , Issue.WEB SERVER ISSUE , pp. W301-W307
    • Walsh, I.1    Seno, F.2    Tosatto, S.C.3    Trovato, A.4
  • 98
    • 5044235541 scopus 로고    scopus 로고
    • Prediction of sequence-dependent and mutational effects on the aggregation of peptides and proteins
    • A.M. Fernandez-Escamilla, F. Rousseau, J. Schymkowitz, and L. Serrano Prediction of sequence-dependent and mutational effects on the aggregation of peptides and proteins Nat Biotechnol 22 10 2004 1302 1306
    • (2004) Nat Biotechnol , vol.22 , Issue.10 , pp. 1302-1306
    • Fernandez-Escamilla, A.M.1    Rousseau, F.2    Schymkowitz, J.3    Serrano, L.4
  • 99
    • 79955610019 scopus 로고    scopus 로고
    • Coupling of aggregation and immunogenicity in biotherapeutics: T- and B-cell immune epitopes may contain aggregation-prone regions
    • S. Kumar, S.K. Singh, X. Wang, B. Rup, and D. Gill Coupling of aggregation and immunogenicity in biotherapeutics: T- and B-cell immune epitopes may contain aggregation-prone regions Pharm Res 28 5 2011 949 961
    • (2011) Pharm Res , vol.28 , Issue.5 , pp. 949-961
    • Kumar, S.1    Singh, S.K.2    Wang, X.3    Rup, B.4    Gill, D.5
  • 100
    • 84862893136 scopus 로고    scopus 로고
    • Relationship between potential aggregation-prone regions and HLA-DR-binding T-cell immune epitopes: Implications for rational design of novel and follow-on therapeutic antibodies
    • S. Kumar, M.A. Mitchell, B. Rup, and S.K. Singh Relationship between potential aggregation-prone regions and HLA-DR-binding T-cell immune epitopes: implications for rational design of novel and follow-on therapeutic antibodies J Pharm Sci 101 8 2012 2686 2701
    • (2012) J Pharm Sci , vol.101 , Issue.8 , pp. 2686-2701
    • Kumar, S.1    Mitchell, M.A.2    Rup, B.3    Singh, S.K.4
  • 101
    • 85016001764 scopus 로고    scopus 로고
    • Industry perspective on the medical risk of visible particles in injectable drug products
    • S. Bukofzer, J. Ayres, A. Chavez, and et al. Industry perspective on the medical risk of visible particles in injectable drug products PDA J Pharm Sci Technol 69 1 2015 123 139
    • (2015) PDA J Pharm Sci Technol , vol.69 , Issue.1 , pp. 123-139
    • Bukofzer, S.1    Ayres, J.2    Chavez, A.3
  • 102
    • 77955100181 scopus 로고    scopus 로고
    • An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics
    • S.K. Singh, N. Afonina, M. Awwad, and et al. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics J Pharm Sci 99 8 2010 3302 3321
    • (2010) J Pharm Sci , vol.99 , Issue.8 , pp. 3302-3321
    • Singh, S.K.1    Afonina, N.2    Awwad, M.3
  • 103
    • 84865353525 scopus 로고    scopus 로고
    • The future of protein particle characterization and understanding its potential to diminish the immunogenicity of biopharmaceuticals: A shared perspective
    • J.S. Bee, T.J. Goletz, and J.A. Ragheb The future of protein particle characterization and understanding its potential to diminish the immunogenicity of biopharmaceuticals: a shared perspective J Pharm Sci 101 10 2012 3580 3585
    • (2012) J Pharm Sci , vol.101 , Issue.10 , pp. 3580-3585
    • Bee, J.S.1    Goletz, T.J.2    Ragheb, J.A.3
  • 105
    • 84922952911 scopus 로고    scopus 로고
    • Calculating the mass of subvisible protein particles with improved accuracy using microflow imaging data
    • C. Kalonia, O.S. Kumru, I. Prajapati, and et al. Calculating the mass of subvisible protein particles with improved accuracy using microflow imaging data J Pharm Sci 104 2 2015 536 547
    • (2015) J Pharm Sci , vol.104 , Issue.2 , pp. 536-547
    • Kalonia, C.1    Kumru, O.S.2    Prajapati, I.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.