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Volumn 25, Issue 3, 2007, Pages 310-317

Immunogenicity of therapeutic proteins. Part 1: Impact of product handling

Author keywords

Biopharmaceutical; Biosimilar; Epoetin; Immunogenicity; Neutralizing antibody; PRCA; Therapeutic protein

Indexed keywords

BIOMATERIALS; IMMUNOLOGY; PHARMACODYNAMICS; QUALITY ASSURANCE;

EID: 33947710801     PISSN: 07349750     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.biotechadv.2007.01.005     Document Type: Review
Times cited : (64)

References (48)
  • 1
    • 9044230923 scopus 로고    scopus 로고
    • Antibodies to interferon (IFN) in hepatitis C patients relapsing while continuing recombinant IFN-alpha2 therapy
    • Antonelli G., Giannelli G., Currenti M., Simeoni E., Del Vecchio S., Maggi F., et al. Antibodies to interferon (IFN) in hepatitis C patients relapsing while continuing recombinant IFN-alpha2 therapy. Clin Exp Immunol 104 (1996) 384-387
    • (1996) Clin Exp Immunol , vol.104 , pp. 384-387
    • Antonelli, G.1    Giannelli, G.2    Currenti, M.3    Simeoni, E.4    Del Vecchio, S.5    Maggi, F.6
  • 2
    • 0032871741 scopus 로고    scopus 로고
    • Development of antibodies to interferon beta in patients: technical and biological aspects
    • Antonelli G., and Dianzani F. Development of antibodies to interferon beta in patients: technical and biological aspects. Eur Cytokine Netw 10 (1999) 413-422
    • (1999) Eur Cytokine Netw , vol.10 , pp. 413-422
    • Antonelli, G.1    Dianzani, F.2
  • 4
    • 19044392727 scopus 로고    scopus 로고
    • The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes
    • Boven K., Stryker S., Knight J., Thomas A., van Regenmortel M., Kemeny D.M., et al. The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. Kidney Int 67 (2005) 2346-2353
    • (2005) Kidney Int , vol.67 , pp. 2346-2353
    • Boven, K.1    Stryker, S.2    Knight, J.3    Thomas, A.4    van Regenmortel, M.5    Kemeny, D.M.6
  • 5
    • 0035029304 scopus 로고    scopus 로고
    • The incidence of inhibitors in hemophilia A and the induction of immune tolerance
    • Briet E., and Peters M. The incidence of inhibitors in hemophilia A and the induction of immune tolerance. Adv Exp Med Biol 489 (2001) 89-97
    • (2001) Adv Exp Med Biol , vol.489 , pp. 89-97
    • Briet, E.1    Peters, M.2
  • 6
    • 0037075272 scopus 로고    scopus 로고
    • Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin
    • Casadevall N., Nataf J., Viron B., Kolta A., Kiladjian J.J., Martin-Dupont P., et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 346 (2002) 469-475
    • (2002) N Engl J Med , vol.346 , pp. 469-475
    • Casadevall, N.1    Nataf, J.2    Viron, B.3    Kolta, A.4    Kiladjian, J.J.5    Martin-Dupont, P.6
  • 8
    • 0027729733 scopus 로고
    • The development of stable protein formulations: a close look at protein aggregation, deamidation, and oxidation
    • Cleland J.L., Powell M.F., and Shire S.J. The development of stable protein formulations: a close look at protein aggregation, deamidation, and oxidation. Crit Rev Ther Drug Carr Syst 10 (1993) 307-377
    • (1993) Crit Rev Ther Drug Carr Syst , vol.10 , pp. 307-377
    • Cleland, J.L.1    Powell, M.F.2    Shire, S.J.3
  • 9
    • 33644952525 scopus 로고    scopus 로고
    • European Medicines Agency, London Available from: http://www.emea.eu.int/pdfs/human/biosimilar/043704en.pdf
    • Committee for Medicinal Products for Human Use. Guideline on similar biological medicinal products (2005), European Medicines Agency, London. http://www.emea.eu.int/pdfs/human/biosimilar/043704en.pdf Available from: http://www.emea.eu.int/pdfs/human/biosimilar/043704en.pdf
    • (2005) Guideline on similar biological medicinal products
    • Committee for Medicinal Products for Human Use1
  • 17
    • 0033949469 scopus 로고    scopus 로고
    • Correlation between factor VIII genotype and inhibitor development in hemophilia A
    • Fakharzadeh S.S., and Kazazian Jr. H.H. Correlation between factor VIII genotype and inhibitor development in hemophilia A. Semin Thromb Hemost 26 (2000) 167-171
    • (2000) Semin Thromb Hemost , vol.26 , pp. 167-171
    • Fakharzadeh, S.S.1    Kazazian Jr., H.H.2
  • 18
    • 0028853791 scopus 로고
    • Clinical significance of antibodies against calcitonin
    • Grauer A., Ziegler R., and Raue F. Clinical significance of antibodies against calcitonin. Exp Clin Endocrinol Diabetes 103 (1995) 345-351
    • (1995) Exp Clin Endocrinol Diabetes , vol.103 , pp. 345-351
    • Grauer, A.1    Ziegler, R.2    Raue, F.3
  • 19
    • 0025977556 scopus 로고
    • Demonstration of insulin transformation products in insulin vials by high-performance liquid chromatography
    • Gregory R., Edwards S., and Yateman N.A. Demonstration of insulin transformation products in insulin vials by high-performance liquid chromatography. Diabetes Care 14 (1991) 42-48
    • (1991) Diabetes Care , vol.14 , pp. 42-48
    • Gregory, R.1    Edwards, S.2    Yateman, N.A.3
  • 20
    • 0042510222 scopus 로고    scopus 로고
    • Epoetins: differences and their relevance to immunogenicity
    • Haselbeck A. Epoetins: differences and their relevance to immunogenicity. Curr Med Res Opin 19 (2003) 430-432
    • (2003) Curr Med Res Opin , vol.19 , pp. 430-432
    • Haselbeck, A.1
  • 21
    • 0030803840 scopus 로고    scopus 로고
    • Interferon immunogenicity: technical evaluation of interferon-alpha 2a
    • Hochuli E. 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 , Issue.SUPPL. 1
    • Hochuli, E.1
  • 23
    • 0032585852 scopus 로고    scopus 로고
    • Immunogenicity of interferon-alpha 2 in therapy: structural and physiological aspects
    • Kontsek P., Liptakova H., and Kontsekova E. Immunogenicity of interferon-alpha 2 in therapy: structural and physiological aspects. Acta Virol 43 (1999) 63-70
    • (1999) Acta Virol , vol.43 , pp. 63-70
    • Kontsek, P.1    Liptakova, H.2    Kontsekova, E.3
  • 24
    • 0036890997 scopus 로고    scopus 로고
    • Immune responses to therapeutic proteins in humans - clinical significance, assessment and prediction
    • Koren E., Zuckerman L.A., and Mire-Sluis A.R. Immune responses to therapeutic proteins in humans - clinical significance, assessment and prediction. Curr Pharm Biotechnol 3 (2002) 349-360
    • (2002) Curr Pharm Biotechnol , vol.3 , pp. 349-360
    • Koren, E.1    Zuckerman, L.A.2    Mire-Sluis, A.R.3
  • 25
    • 0026463719 scopus 로고
    • Identification of sites of degradation in a therapeutic monoclonal antibody by peptide mapping
    • Kroon D.J., Baldwin-Ferro A., and Lalan P. Identification of sites of degradation in a therapeutic monoclonal antibody by peptide mapping. Pharm Res 9 (1992) 1386-1393
    • (1992) Pharm Res , vol.9 , pp. 1386-1393
    • Kroon, D.J.1    Baldwin-Ferro, A.2    Lalan, P.3
  • 26
    • 0030724407 scopus 로고    scopus 로고
    • Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody HER2
    • Lam X.M., Yang J.Y., and Cleland J.L. Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody HER2. J Pharm Sci 86 (1997) 1250-1255
    • (1997) J Pharm Sci , vol.86 , pp. 1250-1255
    • Lam, X.M.1    Yang, J.Y.2    Cleland, J.L.3
  • 27
    • 0033820860 scopus 로고    scopus 로고
    • T-cell recognition of discrete regions of the thrombolytic drug streptokinase
    • Lawley W.J., Fletcher S., Squire I.B., Woods K.L., and Hewitt C.R. T-cell recognition of discrete regions of the thrombolytic drug streptokinase. Clin Sci (Lond) 99 (2000) 239-246
    • (2000) Clin Sci (Lond) , vol.99 , pp. 239-246
    • Lawley, W.J.1    Fletcher, S.2    Squire, I.B.3    Woods, K.L.4    Hewitt, C.R.5
  • 28
    • 0029637161 scopus 로고
    • Chemical instability of protein pharmaceuticals: mechanisms of oxidation and strategies for stabilization
    • Li S., Schöneich C., and Borchardt R.T. Chemical instability of protein pharmaceuticals: mechanisms of oxidation and strategies for stabilization. Biotechnol Bioeng 48 (1995) 490-500
    • (1995) Biotechnol Bioeng , vol.48 , pp. 490-500
    • Li, S.1    Schöneich, C.2    Borchardt, R.T.3
  • 29
    • 0035760892 scopus 로고    scopus 로고
    • Thrombocytopenia caused by the development of antibodies to thrombopoietin
    • Li J., Yang C., Xia Y., Bertino A., Glaspy J., Roberts M., et al. Thrombocytopenia caused by the development of antibodies to thrombopoietin. Blood 98 (2001) 3241-3248
    • (2001) Blood , vol.98 , pp. 3241-3248
    • Li, J.1    Yang, C.2    Xia, Y.3    Bertino, A.4    Glaspy, J.5    Roberts, M.6
  • 30
    • 25144432914 scopus 로고    scopus 로고
    • Acquired red cell aplasia in association with the use of recombinant erythropoietin in chronic renal failure
    • Lim L.C. Acquired red cell aplasia in association with the use of recombinant erythropoietin in chronic renal failure. Hematology 10 (2005) 255-259
    • (2005) Hematology , vol.10 , pp. 255-259
    • Lim, L.C.1
  • 31
    • 0034812115 scopus 로고    scopus 로고
    • Interferon alfacon-1: a review of its pharmacology and therapeutic efficacy in the treatment of chronic hepatitis C
    • Melian E.B., and Plosker G.L. Interferon alfacon-1: a review of its pharmacology and therapeutic efficacy in the treatment of chronic hepatitis C. Drugs 61 (2001) 1661-1691
    • (2001) Drugs , vol.61 , pp. 1661-1691
    • Melian, E.B.1    Plosker, G.L.2
  • 32
    • 0036908735 scopus 로고    scopus 로고
    • Multi-source biopharmaceuticals: a new perspective
    • Nihalani P., Agrawal M., and Anvekar A. Multi-source biopharmaceuticals: a new perspective. Clin Res Regul Aff 19 (2002) 367-380
    • (2002) Clin Res Regul Aff , vol.19 , pp. 367-380
    • Nihalani, P.1    Agrawal, M.2    Anvekar, A.3
  • 33
    • 0035863468 scopus 로고    scopus 로고
    • Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma
    • Olsen E., Duvic M., Frankel A., Kim Y., Martin A., Vonderheid E., et al. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J Clin Oncol 19 (2001) 376-388
    • (2001) J Clin Oncol , vol.19 , pp. 376-388
    • Olsen, E.1    Duvic, M.2    Frankel, A.3    Kim, Y.4    Martin, A.5    Vonderheid, E.6
  • 35
    • 0029759027 scopus 로고    scopus 로고
    • Antibodies against recombinant human erythropoietin in a patient with erythropoietin-resistant anemia
    • Peces R., de la Torre M., Alcazar R., and Urra J.M. Antibodies against recombinant human erythropoietin in a patient with erythropoietin-resistant anemia. N Engl J Med 335 (1996) 523-524
    • (1996) N Engl J Med , vol.335 , pp. 523-524
    • Peces, R.1    de la Torre, M.2    Alcazar, R.3    Urra, J.M.4
  • 36
    • 0038476357 scopus 로고    scopus 로고
    • Immunogenicity of therapeutic monoclonal antibodies
    • Pendley C., Schantz A., and Wagner C. Immunogenicity of therapeutic monoclonal antibodies. Curr Opin Mol Ther 5 (2003) 172-179
    • (2003) Curr Opin Mol Ther , vol.5 , pp. 172-179
    • Pendley, C.1    Schantz, A.2    Wagner, C.3
  • 37
    • 0030841117 scopus 로고    scopus 로고
    • Treatment-induced antibodies to interleukin-2
    • Prümmer O. Treatment-induced antibodies to interleukin-2. Biotherapy 10 (1997) 15-24
    • (1997) Biotherapy , vol.10 , pp. 15-24
    • Prümmer, O.1
  • 38
    • 0030438946 scopus 로고    scopus 로고
    • Neutralizing antibodies to granulocyte-macrophage colony stimulating factor (GM-CSF) in carcinoma patients following GM-CSF combination therapy
    • Ragnhammar P., and Wadhwa M. Neutralizing antibodies to granulocyte-macrophage colony stimulating factor (GM-CSF) in carcinoma patients following GM-CSF combination therapy. Med Oncol 13 (1996) 161-166
    • (1996) Med Oncol , vol.13 , pp. 161-166
    • Ragnhammar, P.1    Wadhwa, M.2
  • 39
    • 0025943513 scopus 로고
    • Streptokinase immunogenicity in thrombolytic therapy for acute myocardial infarction
    • Rosenschein U., Lenz R., Radnay J., Ben Tovim T., and Rozenszajn L.A. Streptokinase immunogenicity in thrombolytic therapy for acute myocardial infarction. Isr J Med Sci 27 (1991) 541-545
    • (1991) Isr J Med Sci , vol.27 , pp. 541-545
    • Rosenschein, U.1    Lenz, R.2    Radnay, J.3    Ben Tovim, T.4    Rozenszajn, L.A.5
  • 40
    • 33644546683 scopus 로고    scopus 로고
    • An in vivo model to assess factors that may stimulate the generation of an immune reaction to erythropoietin
    • Ryan M.H., Heavner G.A., Brigham-Burke M., McMahon F., Shanahan M.F., Gunturi S.R., et al. An in vivo model to assess factors that may stimulate the generation of an immune reaction to erythropoietin. Int Immunopharmacol 6 (2006) 647-655
    • (2006) Int Immunopharmacol , vol.6 , pp. 647-655
    • Ryan, M.H.1    Heavner, G.A.2    Brigham-Burke, M.3    McMahon, F.4    Shanahan, M.F.5    Gunturi, S.R.6
  • 41
    • 0030754581 scopus 로고    scopus 로고
    • Clinical investigation of the immunogenicity of interferon-alpha 2a
    • Ryff J.C. 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 , Issue.SUPPL. 1
    • Ryff, J.C.1
  • 42
    • 0036591653 scopus 로고    scopus 로고
    • Immunogenicity of rDNA-derived pharmaceuticals
    • Ryff J.C., and Schellekens H. Immunogenicity of rDNA-derived pharmaceuticals. Trends Pharmacol Sci 23 (2002) 254-256
    • (2002) Trends Pharmacol Sci , vol.23 , pp. 254-256
    • Ryff, J.C.1    Schellekens, H.2
  • 43
    • 0036861899 scopus 로고    scopus 로고
    • Immunogenicity of therapeutic proteins: clinical implications and future prospects
    • Schellekens H. Immunogenicity of therapeutic proteins: clinical implications and future prospects. Clin Ther 24 (2002) 1720-1740
    • (2002) Clin Ther , vol.24 , pp. 1720-1740
    • Schellekens, H.1
  • 44
    • 3342969278 scopus 로고    scopus 로고
    • When biotech proteins go off-patent
    • Schellekens H. When biotech proteins go off-patent. Trends Biotechnol 22 (2004) 406-410
    • (2004) Trends Biotechnol , vol.22 , pp. 406-410
    • Schellekens, H.1
  • 45
    • 19044395847 scopus 로고    scopus 로고
    • Follow-on biologics: challenges of the 'next generation'
    • Schellekens H. Follow-on biologics: challenges of the 'next generation'. Nephrol Dial Transplant 20 Suppl 4 (2005) iv31-iv36
    • (2005) Nephrol Dial Transplant , vol.20 , Issue.SUPPL. 4
    • Schellekens, H.1
  • 47
    • 10744225329 scopus 로고    scopus 로고
    • Clinical importance of neutralizing antibodies against interferon-beta in patients with relapsing-remitting multiple sclerosis
    • Sorensen P.S., Ross C., Clemmesen K.M., Bendtzen K., Frederiksen J.L., Jensen K., et al. Clinical importance of neutralizing antibodies against interferon-beta in patients with relapsing-remitting multiple sclerosis. Lancet 362 (2003) 1184-1191
    • (2003) Lancet , vol.362 , pp. 1184-1191
    • Sorensen, P.S.1    Ross, C.2    Clemmesen, K.M.3    Bendtzen, K.4    Frederiksen, J.L.5    Jensen, K.6
  • 48
    • 0033841877 scopus 로고    scopus 로고
    • Immunoregulation and blocking antibodies induced by interferon beta treatment in MS
    • Zang Y.C., Yang D., Hong J., Tejada-Simon M.V., Rivera V.M., and Zhang J.Z. Immunoregulation and blocking antibodies induced by interferon beta treatment in MS. Neurology 55 (2000) 397-404
    • (2000) Neurology , vol.55 , pp. 397-404
    • Zang, Y.C.1    Yang, D.2    Hong, J.3    Tejada-Simon, M.V.4    Rivera, V.M.5    Zhang, J.Z.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.