메뉴 건너뛰기




Volumn 408, Issue , 2014, Pages 1-12

Recommendations for the characterization of immunogenicity response to multiple domain biotherapeutics

Author keywords

Anti drug antibody; Immunogenicity response characterization; Multi domain biotherapeutic

Indexed keywords

ALPHA2B INTERFERON; CARRIER PROTEIN; CERTOLIZUMAB PEGOL; DRUG ANTIBODY; EPITOPE; HAPTEN; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT; IMMUNOGLOBULIN G; INTERFERON BETA SERINE; MACROGOL; MONOCLONAL ANTIBODY; NEUTRALIZING ANTIBODY; PEGINTERFERON BETA1A; POLYCLONAL ANTIBODY; RECOMBINANT PROTEIN;

EID: 84903552494     PISSN: 00221759     EISSN: 18727905     Source Type: Journal    
DOI: 10.1016/j.jim.2014.05.010     Document Type: Review
Times cited : (59)

References (58)
  • 1
    • 77957260557 scopus 로고    scopus 로고
    • The occurrence, induction, specificity and potential effect of antibodies against poly(ethylen glycol)
    • Birkhauser Verlag, Switzerland
    • Armstrong J.K. The occurrence, induction, specificity and potential effect of antibodies against poly(ethylen glycol). PEGylated Protein Drugs: Basic Science and Clinical Applications 2009, 147. Birkhauser Verlag, Switzerland.
    • (2009) PEGylated Protein Drugs: Basic Science and Clinical Applications , pp. 147
    • Armstrong, J.K.1
  • 6
    • 0345404156 scopus 로고    scopus 로고
    • Induction of cross-reactive antibodies against a self protein by immunization with a modified self protein containing a foreign T helper epitope
    • Dalum I., Jensen M.R., Gregorius K., Thomasen C.M., Elsner H.I., Mouritsen S. Induction of cross-reactive antibodies against a self protein by immunization with a modified self protein containing a foreign T helper epitope. Mol. Immunol. 1997, 34:1113.
    • (1997) Mol. Immunol. , vol.34 , pp. 1113
    • Dalum, I.1    Jensen, M.R.2    Gregorius, K.3    Thomasen, C.M.4    Elsner, H.I.5    Mouritsen, S.6
  • 7
    • 84876267546 scopus 로고    scopus 로고
    • Certolizumab pegol: a review of its use in the management of rheumatoid arthritis
    • Deeks E.D. Certolizumab pegol: a review of its use in the management of rheumatoid arthritis. Drugs 2013, 73:75.
    • (2013) Drugs , vol.73 , pp. 75
    • Deeks, E.D.1
  • 9
    • 84872326846 scopus 로고    scopus 로고
    • Phase 1 study of trebananib (AMG 386), an angiogenesis targeting angiopoietin-1/2 antagonist, in Japanese patients with advanced solid tumors
    • Doi T., Ohtsu A., Fuse N., Yoshino T., Tahara M., Shibayama K., Takubo T., Weinreich D.M. Phase 1 study of trebananib (AMG 386), an angiogenesis targeting angiopoietin-1/2 antagonist, in Japanese patients with advanced solid tumors. Cancer Chemother. Pharmacol. 2013, 71:227.
    • (2013) Cancer Chemother. Pharmacol. , vol.71 , pp. 227
    • Doi, T.1    Ohtsu, A.2    Fuse, N.3    Yoshino, T.4    Tahara, M.5    Shibayama, K.6    Takubo, T.7    Weinreich, D.M.8
  • 11
    • 84903519856 scopus 로고    scopus 로고
    • FDA Guidance for industry immunogenicity assessment for therapeutic protein products
    • FDA Guidance for industry immunogenicity assessment for therapeutic protein products. Draft Guidance 2013.
    • (2013) Draft Guidance
  • 12
    • 78650795075 scopus 로고    scopus 로고
    • Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics
    • Finco D., Baltrukonis D., Clements-Egan A., Delaria K., Gunn G.R., Lowe J., Maia M., Wong T. Comparison of competitive ligand-binding assay and bioassay formats for the measurement of neutralizing antibodies to protein therapeutics. J. Pharm. Biomed. Anal. 2011, 54:351.
    • (2011) J. Pharm. Biomed. Anal. , vol.54 , pp. 351
    • Finco, D.1    Baltrukonis, D.2    Clements-Egan, A.3    Delaria, K.4    Gunn, G.R.5    Lowe, J.6    Maia, M.7    Wong, T.8
  • 13
    • 84873353521 scopus 로고    scopus 로고
    • Bispecific antibodies and trispecific immunocytokines for targeting the immune system against cancer: preparing for the future
    • Fournier P., Schirrmacher V. Bispecific antibodies and trispecific immunocytokines for targeting the immune system against cancer: preparing for the future. BioDrugs 2013, 27:35.
    • (2013) BioDrugs , vol.27 , pp. 35
    • Fournier, P.1    Schirrmacher, V.2
  • 14
    • 33746995205 scopus 로고    scopus 로고
    • Control of hyperuricemia in subjects with refractory gout, and induction of antibody against poly(ethylene glycol) (PEG), in a phase I trial of subcutaneous PEGylated urate oxidase
    • Ganson N.J., Kelly S.J., Scarlett E., Sundy J.S., Hershfield M.S. Control of hyperuricemia in subjects with refractory gout, and induction of antibody against poly(ethylene glycol) (PEG), in a phase I trial of subcutaneous PEGylated urate oxidase. Arthritis Res. Ther. 2006, 8:R12.
    • (2006) Arthritis Res. Ther. , vol.8
    • Ganson, N.J.1    Kelly, S.J.2    Scarlett, E.3    Sundy, J.S.4    Hershfield, M.S.5
  • 15
    • 84867760417 scopus 로고    scopus 로고
    • Antibodies against polyethylene glycol in healthy subjects and in patients treated with PEG-conjugated agents
    • Garay R.P., El-Gewely R., Armstrong J.K., Garratty G., Richette P. Antibodies against polyethylene glycol in healthy subjects and in patients treated with PEG-conjugated agents. Expert Opin. Drug Deliv. 2012, 9:1319.
    • (2012) Expert Opin. Drug Deliv. , vol.9 , pp. 1319
    • Garay, R.P.1    El-Gewely, R.2    Armstrong, J.K.3    Garratty, G.4    Richette, P.5
  • 16
    • 0032731690 scopus 로고    scopus 로고
    • Etanercept: therapeutic use in patients with rheumatoid arthritis
    • Garrison L., McDonnell N.D. Etanercept: therapeutic use in patients with rheumatoid arthritis. Ann. Rheum. Dis. 1999, 58(Suppl. 1):I65.
    • (1999) Ann. Rheum. Dis. , vol.58 , Issue.SUPPL. 1
    • Garrison, L.1    McDonnell, N.D.2
  • 19
    • 17844380498 scopus 로고    scopus 로고
    • Pegylation: a novel process for modifying pharmacokinetics
    • Harris J.M., Martin N.E., Modi M. Pegylation: a novel process for modifying pharmacokinetics. Clin. Pharmacokinet. 2001, 40:539.
    • (2001) Clin. Pharmacokinet. , vol.40 , pp. 539
    • Harris, J.M.1    Martin, N.E.2    Modi, M.3
  • 24
    • 0345567056 scopus 로고
    • Reaginic antibody formation in the mouse. II. Enhancement and suppression of anti-hapten antibody formation by priming with carrier
    • Ishizaka K., Okudaira H. Reaginic antibody formation in the mouse. II. Enhancement and suppression of anti-hapten antibody formation by priming with carrier. J. Immunol. 1973, 110:1067.
    • (1973) J. Immunol. , vol.110 , pp. 1067
    • Ishizaka, K.1    Okudaira, H.2
  • 25
    • 84864006019 scopus 로고    scopus 로고
    • Romiplostim for the treatment of primary immune thrombocytopenia
    • Janssens A. Romiplostim for the treatment of primary immune thrombocytopenia. Expert. Rev. Hematol. 2012, 5:133.
    • (2012) Expert. Rev. Hematol. , vol.5 , pp. 133
    • Janssens, A.1
  • 28
    • 0022541334 scopus 로고
    • Factors influencing the immunogenicity of the haptenic drug chlorhexidine in mice. II. The role of the carrier and adjuvants in the induction of IgE and IgG anti-hapten responses
    • Layton G.T., Stanworth D.R., Amos H.E. Factors influencing the immunogenicity of the haptenic drug chlorhexidine in mice. II. The role of the carrier and adjuvants in the induction of IgE and IgG anti-hapten responses. Immunology 1986, 59:459.
    • (1986) Immunology , vol.59 , pp. 459
    • Layton, G.T.1    Stanworth, D.R.2    Amos, H.E.3
  • 29
    • 0031865878 scopus 로고    scopus 로고
    • Use of reinduced experimental autoimmune encephalomyelitis to evaluate the importance of epitope spread
    • Lindsey J.W. Use of reinduced experimental autoimmune encephalomyelitis to evaluate the importance of epitope spread. Int. Immunol. 1998, 10:743.
    • (1998) Int. Immunol. , vol.10 , pp. 743
    • Lindsey, J.W.1
  • 30
    • 77951596808 scopus 로고    scopus 로고
    • Catumaxomab: clinical development and future directions
    • Linke R., Klein A., Seimetz D. Catumaxomab: clinical development and future directions. MAbs 2010, 2:129.
    • (2010) MAbs , vol.2 , pp. 129
    • Linke, R.1    Klein, A.2    Seimetz, D.3
  • 32
    • 35548990621 scopus 로고    scopus 로고
    • Abatacept: a novel treatment for rheumatoid arthritis
    • Lundquist L.M. Abatacept: a novel treatment for rheumatoid arthritis. Expert. Opin. Pharmacother. 2007, 8:2371.
    • (2007) Expert. Opin. Pharmacother. , vol.8 , pp. 2371
    • Lundquist, L.M.1
  • 34
    • 0033562815 scopus 로고    scopus 로고
    • Abrogation of the hematological and biological activities of the interleukin-3/granulocyte-macrophage colony-stimulating factor fusion protein PIXY321 by neutralizing anti-PIXY321 antibodies in cancer patients receiving high-dose carboplatin
    • Miller L.L., Korn E.L., Stevens D.S., Janik J.E., Gause B.L., Kopp W.C., Holmlund J.T., Curti B.D., Sznol M., Smith J.W., Urba W.J., Donegan S.E., Watson T.M., Longo D.L. Abrogation of the hematological and biological activities of the interleukin-3/granulocyte-macrophage colony-stimulating factor fusion protein PIXY321 by neutralizing anti-PIXY321 antibodies in cancer patients receiving high-dose carboplatin. Blood 1999, 93:3250.
    • (1999) Blood , vol.93 , pp. 3250
    • Miller, L.L.1    Korn, E.L.2    Stevens, D.S.3    Janik, J.E.4    Gause, B.L.5    Kopp, W.C.6    Holmlund, J.T.7    Curti, B.D.8    Sznol, M.9    Smith, J.W.10    Urba, W.J.11    Donegan, S.E.12    Watson, T.M.13    Longo, D.L.14
  • 36
    • 0001967883 scopus 로고
    • The carrier effect in the secondary response to hapten-protein conjugates. II. Cellular cooperation
    • Mitchison N. The carrier effect in the secondary response to hapten-protein conjugates. II. Cellular cooperation. Eur. J. Immunol. 1971, 1:18.
    • (1971) Eur. J. Immunol. , vol.1 , pp. 18
    • Mitchison, N.1
  • 37
    • 0041303578 scopus 로고    scopus 로고
    • Immunogenicity of biological therapeutics: a hierarchy of concerns
    • Rosenberg A.S. Immunogenicity of biological therapeutics: a hierarchy of concerns. Dev. Biol. 2003, 112:15.
    • (2003) Dev. Biol. , vol.112 , pp. 15
    • Rosenberg, A.S.1
  • 38
    • 84865349352 scopus 로고    scopus 로고
    • Managing uncertainty: a perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins
    • Rosenberg A.S., Verthelyi D., Cherney B.W. Managing uncertainty: a perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins. J. Pharm. Sci. 2012, 101:3560.
    • (2012) J. Pharm. Sci. , vol.101 , pp. 3560
    • Rosenberg, A.S.1    Verthelyi, D.2    Cherney, B.W.3
  • 40
    • 84878831095 scopus 로고    scopus 로고
    • The immunogenicity of polyethylene glycol: facts and fiction
    • Schellekens H., Hennink W.E., Brinks V. The immunogenicity of polyethylene glycol: facts and fiction. Pharm. Res. 2013, 30:1729.
    • (2013) Pharm. Res. , vol.30 , pp. 1729
    • Schellekens, H.1    Hennink, W.E.2    Brinks, V.3
  • 41
    • 84874656491 scopus 로고    scopus 로고
    • Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis
    • Schouwenburg P.A., Rispens T., Wolbink G.J. Immunogenicity of anti-TNF biologic therapies for rheumatoid arthritis. Nat. Rev. Rheumatol. 2013, 9:164.
    • (2013) Nat. Rev. Rheumatol. , vol.9 , pp. 164
    • Schouwenburg, P.A.1    Rispens, T.2    Wolbink, G.J.3
  • 42
    • 0031791942 scopus 로고    scopus 로고
    • Deaggregated homologous immunoglobulin-peptide conjugates induce peptide-specific T cell nonresponsiveness in vivo
    • Seddon B., Mason D. Deaggregated homologous immunoglobulin-peptide conjugates induce peptide-specific T cell nonresponsiveness in vivo. Eur. J. Immunol. 1998, 28:4313.
    • (1998) Eur. J. Immunol. , vol.28 , pp. 4313
    • Seddon, B.1    Mason, D.2
  • 43
    • 84863688504 scopus 로고    scopus 로고
    • The discovery and development of brentuximab vedotin for use in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma
    • Senter P.D., Sievers E.L. The discovery and development of brentuximab vedotin for use in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma. Nat. Biotechnol. 2012, 30:631.
    • (2012) Nat. Biotechnol. , vol.30 , pp. 631
    • Senter, P.D.1    Sievers, E.L.2
  • 44
    • 33744950980 scopus 로고    scopus 로고
    • Scientific and regulatory considerations on the immunogenicity of biologics
    • Shankar G., Shores E., Wagner C., Mire-Sluis A. Scientific and regulatory considerations on the immunogenicity of biologics. Trends Biotechnol. 2006, 24:274.
    • (2006) Trends Biotechnol. , vol.24 , pp. 274
    • Shankar, G.1    Shores, E.2    Wagner, C.3    Mire-Sluis, A.4
  • 45
    • 34249684926 scopus 로고    scopus 로고
    • A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
    • Shankar G., Pendley C., Stein K. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat. Biotechnol. 2007, 25:555.
    • (2007) Nat. Biotechnol. , vol.25 , pp. 555
    • Shankar, G.1    Pendley, C.2    Stein, K.3
  • 47
    • 79957532382 scopus 로고    scopus 로고
    • Summary of confirmation cut point discussions
    • Smith H.W., Moxness M., Marsden R. Summary of confirmation cut point discussions. AAPS J. 2011, 13:227.
    • (2011) AAPS J. , vol.13 , pp. 227
    • Smith, H.W.1    Moxness, M.2    Marsden, R.3
  • 49
    • 47249143734 scopus 로고    scopus 로고
    • Bi20 (fBTA05), a novel trifunctional bispecific antibody (anti-CD20×anti-CD3), mediates efficient killing of B-cell lymphoma cells even with very low CD20 expression levels
    • Stanglmaier M., Faltin M., Ruf P., Bodenhausen A., Schroder P., Lindhofer H. Bi20 (fBTA05), a novel trifunctional bispecific antibody (anti-CD20×anti-CD3), mediates efficient killing of B-cell lymphoma cells even with very low CD20 expression levels. Int. J. Cancer 2008, 123:1181.
    • (2008) Int. J. Cancer , vol.123 , pp. 1181
    • Stanglmaier, M.1    Faltin, M.2    Ruf, P.3    Bodenhausen, A.4    Schroder, P.5    Lindhofer, H.6
  • 50
    • 84855340009 scopus 로고    scopus 로고
    • Activated T cells from umbilical cord blood armed with anti-CD3×anti-CD20 bispecific antibody mediate specific cytotoxicity against CD20+ targets with minimal allogeneic reactivity: a strategy for providing antitumor effects after cord blood transplants
    • Thakur A., Sorenson C., Norkina O., Schalk D., Ratanatharathorn V., Lum L.G. Activated T cells from umbilical cord blood armed with anti-CD3×anti-CD20 bispecific antibody mediate specific cytotoxicity against CD20+ targets with minimal allogeneic reactivity: a strategy for providing antitumor effects after cord blood transplants. Transfusion 2012, 52:63.
    • (2012) Transfusion , vol.52 , pp. 63
    • Thakur, A.1    Sorenson, C.2    Norkina, O.3    Schalk, D.4    Ratanatharathorn, V.5    Lum, L.G.6
  • 51
    • 0030899404 scopus 로고    scopus 로고
    • Diversity and plasticity of self recognition during the development of multiple sclerosis
    • Tuohy V.K., Yu M., Weinstock-Guttman B., Kinkel R.P. Diversity and plasticity of self recognition during the development of multiple sclerosis. J. Clin. Invest. 1997, 99:1682.
    • (1997) J. Clin. Invest. , vol.99 , pp. 1682
    • Tuohy, V.K.1    Yu, M.2    Weinstock-Guttman, B.3    Kinkel, R.P.4
  • 52
    • 0034650422 scopus 로고    scopus 로고
    • Pathologic role and temporal appearance of newly emerging autoepitopes in relapsing experimental autoimmune encephalomyelitis
    • Vanderlugt C.L., Neville K.L., Nikcevich K.M., Eagar T.N., Bluestone J.A., Miller S.D. Pathologic role and temporal appearance of newly emerging autoepitopes in relapsing experimental autoimmune encephalomyelitis. J. Immunol. 2000, 164:670.
    • (2000) J. Immunol. , vol.164 , pp. 670
    • Vanderlugt, C.L.1    Neville, K.L.2    Nikcevich, K.M.3    Eagar, T.N.4    Bluestone, J.A.5    Miller, S.D.6
  • 53
    • 0020638271 scopus 로고
    • The use of haptenated immunoglobulins to induce B cell tolerance in vitro. The roles of hapten density and the Fc portion of the immunoglobulin carrier
    • Waldschmidt T.J., Borel Y., Vitetta E.S. The use of haptenated immunoglobulins to induce B cell tolerance in vitro. The roles of hapten density and the Fc portion of the immunoglobulin carrier. J. Immunol. 1983, 131:2204.
    • (1983) J. Immunol. , vol.131 , pp. 2204
    • Waldschmidt, T.J.1    Borel, Y.2    Vitetta, E.S.3
  • 54
    • 34248589255 scopus 로고    scopus 로고
    • Anti-PEG IgM elicited by injection of liposomes is involved in the enhanced blood clearance of a subsequent dose of PEGylated liposomes
    • Wang X., Ishida T., Kiwada H. Anti-PEG IgM elicited by injection of liposomes is involved in the enhanced blood clearance of a subsequent dose of PEGylated liposomes. J. Control. Release 2007, 119:236.
    • (2007) J. Control. Release , vol.119 , pp. 236
    • Wang, X.1    Ishida, T.2    Kiwada, H.3
  • 56
    • 0029975898 scopus 로고    scopus 로고
    • A predictable sequential determinant spreading cascade invariably accompanies progression of experimental autoimmune encephalomyelitis: a basis for peptide-specific therapy after onset of clinical disease
    • Yu M., Johnson J.M., Tuohy V.K. A predictable sequential determinant spreading cascade invariably accompanies progression of experimental autoimmune encephalomyelitis: a basis for peptide-specific therapy after onset of clinical disease. J. Exp. Med. 1996, 183:1777.
    • (1996) J. Exp. Med. , vol.183 , pp. 1777
    • Yu, M.1    Johnson, J.M.2    Tuohy, V.K.3
  • 57
    • 0029995883 scopus 로고    scopus 로고
    • Epitope-specific tolerance induction with an engineered immunoglobulin
    • Zambidis E.T., Scott D.W. Epitope-specific tolerance induction with an engineered immunoglobulin. Proc. Natl. Acad. Sci. U. S. A. 1996, 93:5019.
    • (1996) Proc. Natl. Acad. Sci. U. S. A. , vol.93 , pp. 5019
    • Zambidis, E.T.1    Scott, D.W.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.