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Volumn 104, Issue 11, 2015, Pages 3691-3702

The Effect of Small Oligomeric Protein Aggregates on the Immunogenicity of Intravenous and Subcutaneous Administered Antibodies

Author keywords

biotechnology; IgG antibody; immune response; particle size; proteins

Indexed keywords

BISPECIFIC ANTIBODY; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR ALPHA; PROTEIN AGGREGATE;

EID: 84944178854     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.24592     Document Type: Article
Times cited : (38)

References (35)
  • 1
    • 84859758529 scopus 로고    scopus 로고
    • Native-like aggregates of factor VIII are immunogenic in von Willebrand factor deficient and hemophilia a mice
    • Pisal DS, Kosloski MP, Middaugh CR, Bankert RB, Balu-Iyer SV,. 2012. Native-like aggregates of factor VIII are immunogenic in von Willebrand factor deficient and hemophilia a mice. J Pharm Sci 101 (6): 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    Sv, B.-I.5
  • 2
    • 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
    • Hermeling S, Schellekens H, Maas C, Gebbink MF, Crommelin DJ, Jiskoot W,. 2006. 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): 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
  • 3
    • 32644434554 scopus 로고    scopus 로고
    • Influence of aggregation on immunogenicity of recombinant human factor VIII in hemophilia A mice
    • Purohit VS, Middaugh CR, Balasubramanian SV,. 2006. Influence of aggregation on immunogenicity of recombinant human factor VIII in hemophilia A mice. J Pharm Sci 95 (2): 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
  • 4
    • 79955610019 scopus 로고    scopus 로고
    • Coupling of aggregation and immunogenicity in biotherapeutics: T- and B-cell immune epitopes may contain aggregation-prone regions
    • Kumar S, Singh SK, Wang X, Rup B, Gill D,. 2011. Coupling of aggregation and immunogenicity in biotherapeutics: T- and B-cell immune epitopes may contain aggregation-prone regions. Pharm Res 28 (5): 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
  • 5
    • 33748041958 scopus 로고    scopus 로고
    • Effects of protein aggregates: An immunologic perspective
    • Rosenberg AS,. 2006. Effects of protein aggregates: An immunologic perspective. AAPS J 8 (3): E501-E507.
    • (2006) AAPS J , vol.8 , Issue.3 , pp. E501-E507
    • Rosenberg, A.S.1
  • 7
    • 84455208309 scopus 로고    scopus 로고
    • Classification of protein aggregates
    • Narhi LO, Schmit J, Bechtold-Peters K, Sharma D,. 2012. Classification of protein aggregates. J Pharm Sci 101 (2): 493-498.
    • (2012) J Pharm Sci , vol.101 , Issue.2 , pp. 493-498
    • Narhi, L.O.1    Schmit, J.2    Sharma, D.3
  • 8
    • 84922645523 scopus 로고    scopus 로고
    • Guidance for Industry. Accessed July 22
    • Guidance for Industry. Immunogenicity assessment for therapeutic protein products. Accessed July 22, 2013, at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338856.pdf.
    • (2013) Immunogenicity Assessment for Therapeutic Protein Products
  • 9
    • 84887999676 scopus 로고    scopus 로고
    • Immunogenicity of subcutaneously administered therapeutic proteins - A mechanistic perspective
    • Fathallah AM, Bankert RB, Balu-Iyer SV,. 2013. Immunogenicity of subcutaneously administered therapeutic proteins-A mechanistic perspective. AAPS J 15: 897-900.
    • (2013) AAPS J , vol.15 , pp. 897-900
    • Fathallah, A.M.1    Bankert, R.B.2    Sv, B.-I.3
  • 10
    • 1842377506 scopus 로고    scopus 로고
    • Antigen-unspecific B cells and lymphoid dendritic cells both show extensive surface expression of processed antigen-major histocompatibility complex class II complexes after soluble protein exposure in vivo or in vitro
    • Zhong GM, Sousa CRE, Germain RN,. 1997. Antigen-unspecific B cells and lymphoid dendritic cells both show extensive surface expression of processed antigen-major histocompatibility complex class II complexes after soluble protein exposure in vivo or in vitro. J Exp Med 186 (5): 673-682.
    • (1997) J Exp Med , vol.186 , Issue.5 , pp. 673-682
    • Zhong, G.M.1    Sousa, C.R.E.2    Germain, R.N.3
  • 11
    • 0029038921 scopus 로고
    • Dendritic cell loss from nonlymphoid tissues after systemic administration of lipopolysaccharide, tumor necrosis factor, and interleukin 1
    • Roake JA, Rao AS, Morris PJ, Larsen CP, Hankins DF, Austyn JM,. 1995. Dendritic cell loss from nonlymphoid tissues after systemic administration of lipopolysaccharide, tumor necrosis factor, and interleukin 1. J Exp Med 181 (6): 2237-2247.
    • (1995) J Exp Med , vol.181 , Issue.6 , pp. 2237-2247
    • Roake, J.A.1    Rao, A.S.2    Morris, P.J.3    Larsen, C.P.4    Hankins, D.F.5    Austyn, J.M.6
  • 12
    • 0029121159 scopus 로고
    • Epidermal Langerhans cell migration: Signals and mechanisms
    • Cumberbatch M, Fielding I, Kimber I,. 1995. Epidermal Langerhans cell migration: Signals and mechanisms. Adv Exp Med Biol 378: 173-175.
    • (1995) Adv Exp Med Biol , vol.378 , pp. 173-175
    • Cumberbatch, M.1    Fielding, I.2    Kimber, I.3
  • 13
    • 77949812737 scopus 로고    scopus 로고
    • Use of a folding model and in situ spectroscopic techniques for rational formulation development and stability testing of monoclonal antibody therapeutics
    • Rao G, Iyer V, Kosloski MP, Pisal DS, Shin E, Middaugh CR, Balu-Iyer SV,. 2010. Use of a folding model and in situ spectroscopic techniques for rational formulation development and stability testing of monoclonal antibody therapeutics. J Pharm Sci 99 (4): 1697-1706.
    • (2010) J Pharm Sci , vol.99 , Issue.4 , pp. 1697-1706
    • Rao, G.1    Iyer, V.2    Kosloski, M.P.3    Pisal, D.S.4    Shin, E.5    Middaugh, C.R.6    Sv, B.-I.7
  • 14
    • 84944166341 scopus 로고    scopus 로고
    • Protein aggregation pathways, kinetics and thermodynamics
    • Wang W. Roberts C.J. Eds. Hoboken, New Jersey: John Wiley and Sons Inc.
    • Li Y, Roberts CJ,. 2012. Protein aggregation pathways, kinetics and thermodynamics In Aggregation of therapeutic proteins;, Wang W, Roberts CJ, Eds. Hoboken, New Jersey: John Wiley and Sons Inc.
    • (2012) Aggregation of Therapeutic Proteins
    • Li, Y.1    Roberts, C.J.2
  • 15
    • 16844367771 scopus 로고    scopus 로고
    • A risk-based approach to immunogenicity concerns for therapeutic protein products
    • Rosenberg AS, Worobec AS,. 2005. A risk-based approach to immunogenicity concerns for therapeutic protein products. Biopharm Int 18 (1): 32 -36.
    • (2005) Biopharm Int , vol.18 , Issue.1 , pp. 32-36
    • Rosenberg, A.S.1    Worobec, A.S.2
  • 16
    • 0032429160 scopus 로고    scopus 로고
    • A statistically defined endpoint titer determination method for immunoassays
    • Frey A, Di Canzio J, Zurakowski D,. 1998. A statistically defined endpoint titer determination method for immunoassays. J Immunol Methods 221 (1-2): 35-41.
    • (1998) J Immunol Methods , vol.221 , Issue.1-2 , pp. 35-41
    • Frey, A.1    Canzio, J.D.2    Zurakowski, D.3
  • 17
    • 38549102077 scopus 로고    scopus 로고
    • TNF-mediated inflammatory disease
    • Bradley JR,. 2008. TNF-mediated inflammatory disease. J Pathol 214 (2): 149-160.
    • (2008) J Pathol , vol.214 , Issue.2 , pp. 149-160
    • Bradley, J.R.1
  • 19
    • 0031811543 scopus 로고    scopus 로고
    • The tumour necrosis factor family of receptors/ligands in the serum of patients with rheumatoid arthritis
    • Robak T, Gladalska A, Stepien H,. 1998. The tumour necrosis factor family of receptors/ligands in the serum of patients with rheumatoid arthritis. Eur Cytokine Netw 9 (2): 145-154.
    • (1998) Eur Cytokine Netw , vol.9 , Issue.2 , pp. 145-154
    • Robak, T.1    Gladalska, A.2    Stepien, H.3
  • 20
    • 0034305809 scopus 로고    scopus 로고
    • Kinetics of dendritic cell activation: Impact on priming of TH1, TH2 and nonpolarized T cells
    • Langenkamp A, Messi M, Lanzavecchia A, Sallusto F,. 2000. Kinetics of dendritic cell activation: Impact on priming of TH1, TH2 and nonpolarized T cells. Nat Immunol 1 (4): 311-316.
    • (2000) Nat Immunol , vol.1 , Issue.4 , pp. 311-316
    • Langenkamp, A.1    Messi, M.2    Lanzavecchia, A.3    Sallusto, F.4
  • 21
    • 0033012030 scopus 로고    scopus 로고
    • An advanced culture method for generating large quantities of highly pure dendritic cells from mouse bone marrow
    • Lutz MB, Kukutsch N, Ogilvie AL, Rossner S, Koch F, Romani N, Schuler G,. 1999. An advanced culture method for generating large quantities of highly pure dendritic cells from mouse bone marrow. J Immunol Methods 223 (1): 77-92.
    • (1999) J Immunol Methods , vol.223 , Issue.1 , pp. 77-92
    • Lutz, M.B.1    Kukutsch, N.2    Ogilvie, A.L.3    Rossner, S.4    Koch, F.5    Romani, N.6    Schuler, G.7
  • 25
    • 84878155949 scopus 로고    scopus 로고
    • Subcutaneous abatacept for the treatment of rheumatoid arthritis
    • Schiff M,. 2013. Subcutaneous abatacept for the treatment of rheumatoid arthritis. Rheumatology (Oxford) 52 (6): 986-997.
    • (2013) Rheumatology (Oxford) , vol.52 , Issue.6 , pp. 986-997
    • Schiff, M.1
  • 26
    • 48249094543 scopus 로고    scopus 로고
    • Novel vaccines and adjuvant systems: The utility of animal models for predicting immunogenicity in humans
    • Davis HL,. 2008. Novel vaccines and adjuvant systems: The utility of animal models for predicting immunogenicity in humans. Hum Vaccin 4 (3): 246-250.
    • (2008) Hum Vaccin , vol.4 , Issue.3 , pp. 246-250
    • Davis, H.L.1
  • 27
    • 84860335491 scopus 로고    scopus 로고
    • Innate immunity mediates follicular transport of particulate but not soluble protein antigen
    • Link A, Zabel F, Schnetzler Y, Titz A, Brombacher F, Bachmann MF,. 2012. Innate immunity mediates follicular transport of particulate but not soluble protein antigen. J Immunol 188 (8): 3724-3733.
    • (2012) J Immunol , vol.188 , Issue.8 , pp. 3724-3733
    • Link, A.1    Zabel, F.2    Schnetzler, Y.3    Titz, A.4    Brombacher, F.5    Bachmann, M.F.6
  • 28
    • 84869805746 scopus 로고    scopus 로고
    • The origins of viruses
    • Wessner DR,. 2010. The origins of viruses. Nat Educ 3 (9): 37.
    • (2010) Nat Educ , vol.3 , Issue.9 , pp. 37
    • Wessner, D.R.1
  • 30
    • 29244450505 scopus 로고    scopus 로고
    • Partitioning conformational intermediates between competing refolding and aggregation pathways: Insights into transthyretin amyloid disease
    • Wiseman RL, Powers ET, Kelly JW,. 2005. Partitioning conformational intermediates between competing refolding and aggregation pathways: Insights into transthyretin amyloid disease. Biochemistry 44 (50): 16612-16623.
    • (2005) Biochemistry , vol.44 , Issue.50 , pp. 16612-16623
    • Wiseman, R.L.1    Powers, E.T.2    Kelly, J.W.3
  • 31
    • 0242336022 scopus 로고    scopus 로고
    • C-terminal hydrophobic interactions play a critical role in oligomeric assembly of the P22 tailspike trimer
    • Gage MJ, Robinson AS,. 2003. C-terminal hydrophobic interactions play a critical role in oligomeric assembly of the P22 tailspike trimer. Protein Sci 12 (12): 2732-2747.
    • (2003) Protein Sci , vol.12 , Issue.12 , pp. 2732-2747
    • Gage, M.J.1    Robinson, A.S.2
  • 32
    • 0031592933 scopus 로고    scopus 로고
    • Formation of a denatured dimer limits the thermal stability of Arc repressor
    • Robinson CR, Rentzeperis D, Silva JL, Sauer RT,. 1997. Formation of a denatured dimer limits the thermal stability of Arc repressor. J Mol Biol 273 (3): 692-700.
    • (1997) J Mol Biol , vol.273 , Issue.3 , pp. 692-700
    • Robinson, C.R.1    Rentzeperis, D.2    Silva, J.L.3    Sauer, R.T.4
  • 33
    • 84859327683 scopus 로고    scopus 로고
    • The influence of charge distribution on self-association and viscosity behavior of monoclonal antibody solutions
    • Yadav S, Laue TM, Kalonia DS, Singh SN, Shire SJ,. 2012. The influence of charge distribution on self-association and viscosity behavior of monoclonal antibody solutions. Mol Pharm 9 (4): 791-802.
    • (2012) Mol Pharm , vol.9 , Issue.4 , pp. 791-802
    • Yadav, S.1    Laue, T.M.2    Kalonia, D.S.3    Singh, S.N.4    Shire, S.J.5
  • 34
    • 76649099495 scopus 로고    scopus 로고
    • Specific interactions in high concentration antibody solutions resulting in high viscosity
    • Yadav S, Liu J, Shire SJ, Kalonia DS,. 2010. Specific interactions in high concentration antibody solutions resulting in high viscosity. J Pharm Sci 99 (3): 1152-1168.
    • (2010) J Pharm Sci , vol.99 , Issue.3 , pp. 1152-1168
    • Yadav, S.1    Liu, J.2    Shire, S.J.3    Kalonia, D.S.4


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