Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.
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Rafael Ponce | Lakshmi Amaravadi | Gopi Shankar | G. Shankar | R. Ponce | B. Mounho | James D. Green | Shalini Gupta | Bonita Rup | T. Gelzleichter | D. Herzyk | Inge A Ivens | Christopher Hurst | Barbara Mounho | Holly Smith | Leslie Abad | Thomas Gelzleichter | Elizabeth Gore | James Green | Danuta Herzyk | Thomas Kawabata | Curtis Maier | Peter Thomas | Dan Wierda | Holly W. Smith | T. Kawabata | Shalini Gupta | D. Wierda | B. Rup | I. Ivens | L. Amaravadi | C. Maier | Peter Thomas | E. Gore | Leslie Abad | Christopher Hurst | C. Hurst
[1] D. Wierda. Animal Models for Preclinical Comparative Immunogenicity Testing , 2008 .
[2] J. Arnout,et al. Factor VIII Inhibitors in Previously Treated Haemophilia A Patients with a Double Virus-inactivated Plasma Derived Factor VIII Concentrate , 1997, Thrombosis and Haemostasis.
[3] J. Shabanowitz,et al. An HLA-A2-restricted tyrosinase antigen on melanoma cells results from posttranslational modification and suggests a novel pathway for processing of membrane proteins , 1996, The Journal of experimental medicine.
[4] N V Katre,et al. Immunogenicity of recombinant IL-2 modified by covalent attachment of polyethylene glycol. , 1990, Journal of immunology.
[5] George Scott,et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. , 2004, Journal of immunological methods.
[6] D. Vignali,et al. How regulatory T cells work , 2008, Nature Reviews Immunology.
[7] M. Nussenzweig,et al. Predominant Autoantibody Production by Early Human B Cell Precursors , 2003, Science.
[8] M. Streiff,et al. Acquired FV inhibitors: a needless iatrogenic complication of bovine thrombin exposure , 2002, Transfusion.
[9] J. Rossert. Erythropoietin‐induced, antibody‐mediated pure red cell aplasia * , 2005, European journal of clinical investigation.
[10] S. Strobel,et al. Immune responses to dietary antigens: oral tolerance. , 1998, Immunology today.
[11] D. Scott,et al. Activation of natural regulatory T cells by IgG Fc-derived peptide "Tregitopes". , 2008, Blood.
[12] Leonard Moise,et al. Prediction of immunogenicity for therapeutic proteins: state of the art. , 2007, Current opinion in drug discovery & development.
[13] Patrick Mayeux,et al. Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. , 2002, The New England journal of medicine.
[14] An Carbonez,et al. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. , 2003, The New England journal of medicine.
[15] A. Badger,et al. Preclinical development of keliximab, a Primatized™ anti-CD4 monoclonal antibody, in human CD4 transgenic mice: characterization of the model and safety studies , 2000, Human & experimental toxicology.
[16] M. Biffoni,et al. Incidence of antibodies to interferon-beta in patients treated with recombinant human interferon-beta 1a from mammalian cells. , 1997, Cytokines, cellular & molecular therapy.
[17] L. Klein,et al. Origin of regulatory T cells with known specificity for antigen , 2002, Nature Immunology.
[18] J. Astermark. Basic aspects of inhibitors to factors VIII and IX and the influence of non‐genetic risk factors , 2006, Haemophilia : the official journal of the World Federation of Hemophilia.
[19] S. Jameson,et al. Central tolerance: learning self-control in the thymus , 2005, Nature Reviews Immunology.
[20] Hendrik Neubert,et al. Assessing immunogenicity in the presence of excess protein therapeutic using immunoprecipitation and quantitative mass spectrometry. , 2008, Analytical chemistry.
[21] Kai-Uwe Eckardt,et al. Epoetin-induced autoimmune pure red cell aplasia. , 2005, Journal of the American Society of Nephrology : JASN.
[22] G. Avgerinos,et al. Production and clinical development of a Hansenula polymorpha-derived PEGylated hirudin. , 2001, Seminars in thrombosis and hemostasis.
[23] R. Steinman,et al. The Induction of Tolerance by Dendritic Cells That Have Captured Apoptotic Cells , 2000, The Journal of experimental medicine.
[24] H. Doyle,et al. Post-translational protein modifications in antigen recognition and autoimmunity. , 2001, Trends in immunology.
[25] P. Bugelski,et al. Immunopharmacology of recombinant human interleukin-18 in non-human primates. , 2002, Cytokine.
[26] M. Urowitz,et al. CAMPATH-1H, a humanized monoclonal antibody, in refractory rheumatoid arthritis. An intravenous dose-escalation study. , 1995, Arthritis and rheumatism.
[27] S. Pestka,et al. Interferon immunogenicity: preclinical evaluation of interferon-alpha 2a. , 1997, Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research.
[28] A. Sette,et al. Isoaspartyl Post-translational Modification Triggers Autoimmune Responses to Self-proteins* , 1999, The Journal of Biological Chemistry.
[29] Mark C Evans,et al. Recent advances in immunoinformatics: application of in silico tools to drug development. , 2008, Current opinion in drug discovery & development.
[30] Ying Tang,et al. Monoclonal Antibody Clearance , 2007, Journal of Biological Chemistry.
[31] A. Agulnik,et al. The HLA-A*0201-restricted H-Y antigen contains a posttranslationally modified cysteine that significantly affects T cell recognition. , 1997, Immunity.
[32] Francesco M Veronese,et al. PEGylation, successful approach to drug delivery. , 2005, Drug discovery today.
[33] H. Weiner,et al. Regulatory T cell clones induced by oral tolerance: suppression of autoimmune encephalomyelitis. , 1994, Science.
[34] S. Belknap,et al. Long-term outcome of individuals with pure red cell aplasia and antierythropoietin antibodies in patients treated with recombinant epoetin: a follow-up report from the Research on Adverse Drug Events and Reports (RADAR) Project. , 2005, Blood.
[35] P. Shaw,et al. Reducing the immunogenicity and improving the in vivo activity of trichosanthin by site-directed pegylation. , 1999, Life sciences.
[36] Viswanath Devanarayan,et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. , 2008, Journal of pharmaceutical and biomedical analysis.
[37] D. Dresser. Specific inhibition of antibody production. II. Paralysis induced in adult mice by small quantities of protein antigen. , 1962, Immunology.
[38] G. Woods,et al. Neonatal exposure to UV‐B radiation leads to a large reduction in Langerhans cell density, but by maturity, there is an enhanced ability of dendritic cells to stimulate T cells , 2006, Immunology and cell biology.
[39] Marian Kelley,et al. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. , 2007, Journal of immunological methods.
[40] Julie McMurry,et al. Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates. , 2008, Current opinion in pharmacology.
[41] Allen Schantz,et al. Immunogenicity of therapeutic monoclonal antibodies. , 2003, Current opinion in molecular therapeutics.
[42] Steven J. Swanson,et al. Evaluation of Methods to Detect and Characterize Antibodies against Recombinant Human Erythropoietin , 2004, Nephron Clinical Practice.
[43] C. Kurts,et al. Brief Definitive Report Major Histocompatibility Complex Class I–restricted Cross-presentation Is Biased towards High Dose Antigens and Those Released during Cellular Destruction , 2022 .
[44] H. Weiner,et al. Peripheral deletion of antigen-reactive T cells in oral tolerance , 1995, Nature.
[45] Gopi Shankar,et al. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs , 2007, Nature Biotechnology.
[46] H. Weiner,et al. Activation of CD25+CD4+ Regulatory T Cells by Oral Antigen Administration1 , 2001, The Journal of Immunology.
[47] P. Matzinger,et al. B cells turn off virgin but not memory T cells. , 1992, Science.
[48] C. Kurts,et al. Cutting Edge: Dendritic Cells Are Sufficient to Cross-Present Self-Antigens to CD8 T Cells In Vivo1 , 2001, The Journal of Immunology.
[49] P. Delamater. Growth disorders: The state of the art Edited by Luciano Cavallo, Jean Claude Job, and Maria 1. New. Serono Symposia Publications, volume 81., New York, Raven, 1991, $110.50 (xv + 372 pages), ISBN 0-881-67786-8 , 1992, Trends in Endocrinology & Metabolism.
[50] James D. Green,et al. Comparative Pathology of Recombinant Murine Interferon-γ in Mice and Recombinant Human Interferon-γ in Cynomolgus Monkeys , 1993 .
[51] H. Gunn. Immunogenicity of recombinant human interleukin-3. , 1997, Clinical immunology and immunopathology.
[52] K. Shokat,et al. Intravenous injection of soluble antigen induces thymic and peripheral T-cells apoptosis. , 1996, Proceedings of the National Academy of Sciences of the United States of America.
[53] Rajat Varma,et al. Peptide-MHC potency governs dynamic interactions between T cells and dendritic cells in lymph nodes , 2007, Nature Immunology.
[54] B. Arnold. Levels of peripheral T cell tolerance. , 2002, Transplant immunology.
[55] Huub Schellekens,et al. Factors influencing the immunogenicity of therapeutic proteins. , 2005, Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association.
[56] R. D. Hatton,et al. Regulatory T Cell Suppression and Anergy Are Differentially Regulated by Proinflammatory Cytokines Produced by TLR-Activated Dendritic Cells1 , 2004, The Journal of Immunology.
[57] A. Faiella,et al. The rhGM-CSF-EPO hybrid protein MEN 11300 induces anti-EPO antibodies and severe anaemia in rhesus monkeys. , 1998, Cytokine.
[58] J. Vielmetter,et al. Clinical link between MHC class II haplotype and interferon-beta (IFN-beta) immunogenicity. , 2006, Clinical immunology.
[59] Bruce N. Rehlaender,et al. Antibodies as Carrier Proteins , 1998, Pharmaceutical Research.
[60] D. Kuter. The use of PEG‐rHuMGDF in platelet apheresis , 1998, Stem cells.
[61] Application of analytical detection concepts to immunogenicity testing. , 2007, Analytical chemistry.
[62] C. Maury,et al. Induction of tolerance to recombinant therapeutic proteins. , 2001, Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research.
[63] T. Elliott,et al. Glycan-regulated Antigen Processing of a Protein in the Endoplasmic Reticulum Can Uncover Cryptic Cytotoxic T Cell Epitopes , 1998, The Journal of experimental medicine.
[64] D. Parker,et al. Small B cells as antigen-presenting cells in the induction of tolerance to soluble protein antigens. , 1992 .
[65] N. Fineberg,et al. Immunologic Effects of Insulin Lispro [Lys (B28), Pro (B29) Human Insulin] in IDDM and NIDDM Patients Previously Treated With Insulin , 1996, Diabetes.
[66] Viswanath Devanarayan,et al. Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products. , 2008, Journal of immunological methods.
[67] P. Bugelski,et al. Predictive power of preclinical studies in animals for the immunogenicity of recombinant therapeutic proteins in humans. , 2004, Current opinion in molecular therapeutics.
[68] U. V. von Andrian,et al. Single-cell dynamics of T-cell priming. , 2007, Current opinion in immunology.
[69] R. Medzhitov,et al. Toll-like receptors: balancing host resistance with immune tolerance. , 2003, Current opinion in immunology.
[70] R. Daynes,et al. The effects of high-dose UV exposure on murine Langerhans cell function at exposed and unexposed sites as assessed using in vivo and in vitro assays. , 1983, The Journal of investigative dermatology.
[71] Basant Sharma,et al. Immunogenicity of therapeutic proteins. Part 3: impact of manufacturing changes. , 2007, Biotechnology advances.
[72] A. Rosenberg,et al. Effects of protein aggregates: An immunologic perspective , 2006, The AAPS Journal.
[73] A. Khoruts,et al. The anatomy of T-cell activation and tolerance. , 1996, Proceedings of the National Academy of Sciences of the United States of America.
[74] M. Hershfield,et al. 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 , 2005, Arthritis research & therapy.
[75] H. Weiner,et al. Induction of anergy or active suppression following oral tolerance is determined by antigen dosage. , 1994, Proceedings of the National Academy of Sciences of the United States of America.
[76] R. Smalling,et al. Granulocyte colony stimulating factor: animal studies for risk assessment. , 1993, International review of experimental pathology.
[77] H. Smith,et al. Immunogenicity of biopharmaceuticals in laboratory animals. , 2001, Toxicology.
[78] A. Jaber,et al. Assessment of the immunogenicity of different interferon beta-1a formulations using ex vivo T-cell assays. , 2007, Journal of pharmaceutical and biomedical analysis.
[79] G. Shankar,et al. Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies. , 2005, Journal of pharmaceutical and biomedical analysis.
[80] J. Griffin,et al. Altered humoral immunity during pregnancy in the guinea pig. , 1987, Journal of reproductive immunology.
[81] M. Lotze,et al. High-Dose Recombinant Interleukin-18 Induces an Effective Th1 Immune Response to Murine MOPC-315 Plasmacytoma , 2002, Journal of immunotherapy.
[82] Hong Zhao,et al. Structure-function engineering of interferon-beta-1b for improving stability, solubility, potency, immunogenicity, and pharmacokinetic properties by site-selective mono-PEGylation. , 2006, Bioconjugate chemistry.
[83] A. Pilaro,et al. Safety Assessment of Biotechnology-Derived Pharmaceuticals: ICH and Beyond , 1999, Toxicologic pathology.
[84] P. Bugelski,et al. Identification of natural antibodies to interleukin-18 in the sera of normal humans and three nonhuman primate species. , 2003, Clinical immunology.
[85] L. Fugger,et al. Tissue transglutaminase selectively modifies gliadin peptides that are recognized by gut-derived T cells in celiac disease , 1998, Nature Medicine.
[86] B. Segal,et al. Activation of APCs Through CD40 or Toll-Like Receptor 9 Overcomes Tolerance and Precipitates Autoimmune Disease1 , 2002, The Journal of Immunology.
[87] Karina Yusim,et al. Immunoinformatics Comes of Age , 2006, PLoS Comput. Biol..
[88] Erika Giste,et al. Preclinical safety of recombinant human thrombin. , 2007, Regulatory toxicology and pharmacology : RTP.
[89] J. Egrie,et al. Use of recombinant human erythropoietin for management of anemia in dogs and cats with renal failure. , 1998, Journal of the American Veterinary Medical Association.
[90] D. Dale,et al. Chronic thrombocytopenia is induced in dogs by development of cross-reacting antibodies to the MpL ligand. , 1997, Blood.
[91] A. Valdés,et al. The HLA-DR2 haplotype is associated with an increased proliferative response to the immunodominant CD4+ T-cell epitope in human interferon-β , 2004, Genes and Immunity.
[92] V. Tomassini,et al. Neutralizing and Binding Antibodies to IFN-β: Relative Frequency in Relapsing-Remitting Multiple Sclerosis Patients Treated with Different IFN-β Preparations , 2002 .
[93] J. Lawson. The clinical use and immunologic impact of thrombin in surgery. , 2006, Seminars in thrombosis and hemostasis.
[94] P. Bugelski,et al. Preclinical Safety of Recombinant Human Interleukin-18 , 2003, Toxicologic pathology.
[95] C. Yang,et al. Thrombocytopenia caused by the development of antibodies to thrombopoietin. , 2001, Blood.
[96] R. Aston,et al. Antibody-mediated enhancement of hormone activity. , 1989, Molecular immunology.
[97] R. Morgan,et al. Genetic induction of immune tolerance to human clotting factor VIII in a mouse model for hemophilia A. , 1998, Proceedings of the National Academy of Sciences of the United States of America.
[98] G. Gregoriadis,et al. Improving the therapeutic efficacy of peptides and proteins: a role for polysialic acids. , 2005, International journal of pharmaceutics.
[99] F. Legay,et al. Improvement of drug tolerance in immunogenicity testing by acid treatment on Biacore. , 2008, Journal of immunological methods.
[100] R. Heine,et al. Efficacy and safety of inhaled insulin in the treatment of diabetes mellitus. , 2006, The Netherlands journal of medicine.
[101] Gopi Shankar,et al. Scientific and regulatory considerations on the immunogenicity of biologics. , 2006, Trends in biotechnology.
[102] A. Enk,et al. Immature, but not inactive: the tolerogenic function of immature dendritic cells , 2002, Immunology and cell biology.
[103] D. Masterman,et al. Development of a Maturing T-Cell-Mediated Immune Response in Patients with Idiopathic Parkinson’s Disease Receiving r-metHuGDNF Via Continuous Intraputaminal Infusion , 2007, Journal of Clinical Immunology.
[104] R. Dwek,et al. Glycosylation and the immune system. , 2001, Science.
[105] Darren R Flower,et al. Immunoinformatics and the prediction of immunogenicity. , 2002, Applied bioinformatics.
[106] A. Mire-Sluis,et al. Immune responses to therapeutic proteins in humans--clinical significance, assessment and prediction. , 2002, Current pharmaceutical biotechnology.
[107] R. Ponce,et al. Toxicity as a result of immunostimulation by biologics , 2007, Expert opinion on drug metabolism & toxicology.
[108] H. Heiken,et al. The IgG Fc receptor family , 1998, Annals of Hematology.
[109] Jochem Alsenz,et al. Protein Aggregates Seem to Play a Key Role Among the Parameters Influencing the Antigenicity of Interferon Alpha (IFN-α) in Normal and Transgenic Mice , 1997, Pharmaceutical Research.
[110] P. Gallo,et al. Interferon-beta (IFN-β) antibodies in interferon-β1a-and interferon-β1b-treated multiple sclerosis patients. Prevalence, kinetics, cross-reactivity, and factors enhancing interferon-β immunogenicity in vivo , 2001 .
[111] L. Shultz,et al. Constant rate of steady-state self-antigen trafficking from skin to regional lymph nodes. , 2006, International immunology.
[112] M. Mihm,et al. Characterization of Langerhans cells by the use of monoclonal antibodies. , 1981, Laboratory investigation; a journal of technical methods and pathology.
[113] A. Khoruts,et al. Studying Immunological Tolerance by Physically Monitoring Antigen‐specific T Cells in Vivo a , 1996, Annals of the New York Academy of Sciences.
[114] M. Wadhwa,et al. Unwanted Immunogenicity: Implications for Follow-on Biologicals , 2007 .
[115] Anthony Mire-Sluis,et al. Characterizing biological products and assessing comparability following manufacturing changes , 2004, Nature Biotechnology.
[116] T. Boone,et al. Clinical validation of the "in silico" prediction of immunogenicity of a human recombinant therapeutic protein. , 2007, Clinical immunology.
[117] E. A. Graham. The Influence of Ether and Ether Anesthesia on Bacteriolysis, Agglutination, and Phagocytosis , 1911 .
[118] C. Orosz,et al. Oral tolerance in experimental autoimmune encephalomyelitis. III. Evidence for clonal anergy. , 1991, Journal of immunology.
[119] Division on Earth. Guide for the Care and Use of Laboratory Animals , 1996 .
[120] G. Giovannoni,et al. The Rebif® New Formulation Story , 2007, Drugs in R&D.
[121] L. Old,et al. Pharmacokinetics and microdistribution of polyethylene glycol‐modified humanized A33 antibody targeting colon cancer xenografts , 2000, International journal of cancer.
[122] T. Hamilton,et al. UV exposure reduces immunization rates and promotes tolerance to epicutaneous antigens in humans: relationship to dose, CD1a-DR+ epidermal macrophage induction, and Langerhans cell depletion. , 1992, Proceedings of the National Academy of Sciences of the United States of America.
[123] W. Heath,et al. Cross-presentation, dendritic cells, tolerance and immunity. , 2001, Annual review of immunology.
[124] E. Harlow,et al. Antibodies: A Laboratory Manual , 1988 .
[125] C. Goodnow,et al. The need for central and peripheral tolerance in the B cell repertoire. , 1990, Science.
[126] H. G. Wells. Studies on the Chemistry of Anaphylaxis (III). Experiments with Isolated Proteins, Especially those of the Hen's Egg , 1911 .