Immunogenicity of protein therapeutics.

[1]  B Stubinski,et al.  Safety and immunogenicity of a new formulation of interferon β-1a (Rebif® New Formulation) in a Phase IIIb study in patients with relapsing multiple sclerosis: 96-week results , 2009, Multiple sclerosis.

[2]  G. Porro,et al.  Adalimumab for the treatment of Crohn’s disease , 2008, Biologics : targets & therapy.

[3]  P. V. van Riel,et al.  Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis , 2008, Annals of the rheumatic diseases.

[4]  H. Scher,et al.  Phase I trial of the prostate-specific membrane antigen-directed immunoconjugate MLN2704 in patients with progressive metastatic castration-resistant prostate cancer. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[5]  N. Hacohen,et al.  Carbohydrate‐Mediated Targeting of Antigen to Dendritic Cells Leads to Enhanced Presentation of Antigen to T Cells , 2008, Chembiochem : a European journal of chemical biology.

[6]  S. Ménard,et al.  Cross‐talk between Toll‐like receptors 5 and 9 on activation of human immune responses , 2007, Journal of leukocyte biology.

[7]  T. Boone,et al.  Clinical validation of the "in silico" prediction of immunogenicity of a human recombinant therapeutic protein. , 2007, Clinical immunology.

[8]  E. Santagostino,et al.  International workshop on immune tolerance induction: consensus recommendations 1 , 2007, Haemophilia : the official journal of the World Federation of Hemophilia.

[9]  Julie A McMurry,et al.  Diversity of Francisella tularensis Schu4 antigens recognized by T lymphocytes after natural infections in humans: identification of candidate epitopes for inclusion in a rationally designed tularemia vaccine. , 2007, Vaccine.

[10]  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.

[11]  Herren Wu,et al.  Framework shuffling of antibodies to reduce immunogenicity and manipulate functional and biophysical properties. , 2007, Molecular immunology.

[12]  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.

[13]  P. Lenting,et al.  Depletion of CD4+/CD25high regulatory T cells may enhance or uncover factor VIII‐specific T‐cell responses in healthy individuals , 2007, Journal of thrombosis and haemostasis : JTH.

[14]  T. Jones,et al.  Identification and removal of immunogenicity in therapeutic proteins. , 2007, Current opinion in drug discovery & development.

[15]  P. Parren,et al.  Immunogenicity screening in protein drug development , 2007, Expert opinion on biological therapy.

[16]  A. Jegerlehner,et al.  TLR9 Signaling in B Cells Determines Class Switch Recombination to IgG2a , 2007, The Journal of Immunology.

[17]  R. Steinman,et al.  Differential Antigen Processing by Dendritic Cell Subsets in Vivo , 2007, Science.

[18]  Devan V Mehrotra,et al.  A comparison of standard immunogenicity assays for monitoring HIV type 1 gag-specific T cell responses in Ad5 HIV Type 1 gag vaccinated human subjects. , 2006, AIDS research and human retroviruses.

[19]  P. S. Andersen,et al.  Reduced Susceptibility of Recombinant Polyclonal Antibodies to Inhibitory Anti-Variable Domain Antibody Responses , 2006, The Journal of Immunology.

[20]  A. Rosenberg,et al.  Effects of protein aggregates: An immunologic perspective , 2006, The AAPS Journal.

[21]  D. Borchelt,et al.  Papillomavirus-Like Particles Are an Effective Platform for Amyloid-β Immunization in Rabbits and Transgenic Mice1 , 2006, The Journal of Immunology.

[22]  J. Reveille The genetic basis of autoantibody production. , 2006, Autoimmunity reviews.

[23]  M. Carcao,et al.  Current and future approaches to inhibitor management and aversion. , 2006, Seminars in thrombosis and hemostasis.

[24]  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.

[25]  Huub Schellekens,et al.  Antibody response to aggregated human interferon alpha2b in wild-type and transgenic immune tolerant mice depends on type and level of aggregation. , 2006, Journal of Pharmacy and Science.

[26]  William W. Kwok,et al.  Antibiotic-refractory Lyme arthritis is associated with HLA-DR molecules that bind a Borrelia burgdorferi peptide , 2006, The Journal of experimental medicine.

[27]  A. Erdei,et al.  Expression and role of Fc- and complement-receptors on human dendritic cells. , 2006, Immunology letters.

[28]  S. Depil,et al.  Peptide-binding assays and HLA II transgenic Abeta degrees mice are consistent and complementary tools for identifying HLA II-restricted peptides. , 2006, Vaccine.

[29]  Karen Vanhoorelbeke,et al.  Humanization by variable domain resurfacing and grafting on a human IgG4, using a new approach for determination of non-human like surface accessible framework residues based on homology modelling of variable domains. , 2006, Molecular immunology.

[30]  J. Isaacs,et al.  The impact of glycosylation on HLA-DR1-restricted T cell recognition of type II collagen in a mouse model. , 2006, Arthritis and rheumatism.

[31]  S. Larson,et al.  Pilot Trial of Unlabeled and Indium-111–Labeled Anti–Prostate-Specific Membrane Antigen Antibody J591 for Castrate Metastatic Prostate Cancer , 2005, Clinical Cancer Research.

[32]  Huub Schellekens,et al.  Structural Characterization and Immunogenicity in Wild-Type and Immune Tolerant Mice of Degraded Recombinant Human Interferon Alpha2b , 2005, Pharmaceutical Research.

[33]  S. Vallabhajosula,et al.  Radioimmunotherapy of Prostate Cancer Using 90Y- and 177Lu-Labeled J591 Monoclonal Antibodies: Effect of Multiple Treatments on Myelotoxicity , 2005, Clinical Cancer Research.

[34]  K. Akashi,et al.  Development of functional human blood and immune systems in NOD/SCID/IL2 receptor γ chainnull mice , 2005 .

[35]  C. Figdor,et al.  Effective induction of naive and recall T-cell responses by targeting antigen to human dendritic cells via a humanized anti-DC-SIGN antibody. , 2005, Blood.

[36]  S. Akira,et al.  Toll-like receptor 9 controls anti-DNA autoantibody production in murine lupus , 2005, The Journal of experimental medicine.

[37]  N. Casadevall,et al.  The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes. , 2005, Kidney international.

[38]  J. Foote,et al.  Immunogenicity of engineered antibodies. , 2005, Methods.

[39]  K. Honda,et al.  Spatiotemporal regulation of MyD88–IRF-7 signalling for robust type-I interferon induction , 2005, Nature.

[40]  John Sidney,et al.  Rationally Engineered Therapeutic Proteins with Reduced Immunogenicity , 2005, The Journal of Immunology.

[41]  D. Niedzwiecki,et al.  Enumerating Antigen-Specific T-Cell Responses in Peripheral Blood: A Comparison of Peptide MHC Tetramer, ELISpot, and Intracellular Cytokine Analysis , 2005, Journal of immunotherapy.

[42]  Anne S De Groot,et al.  From genome to vaccine--new immunoinformatics tools for vaccine design. , 2004, Methods.

[43]  G. Alexander,et al.  The development of a modified human IFN-alpha2b linked to the Fc portion of human IgG1 as a novel potential therapeutic for the treatment of hepatitis C virus infection. , 2004, Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research.

[44]  J. Pearce,et al.  Cotugno and cerebrospinal fluid , 2004, Journal of Neurology, Neurosurgery & Psychiatry.

[45]  J. Watkins,et al.  Limiting the risk of immunogenicity by identification and removal of T-cell epitopes (DeImmunisation™) , 2004, Cancer Cell International.

[46]  Marcia Stickler,et al.  Elimination of an Immunodominant CD4+ T Cell Epitope in Human IFN-β Does Not Result in an In Vivo Response Directed at the Subdominant Epitope , 2004, The Journal of Immunology.

[47]  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.

[48]  S. Madoiwa,et al.  Induction of immune tolerance by neonatal intravenous injection of human factor VIII in murine hemophilia A , 2004, Journal of thrombosis and haemostasis : JTH.

[49]  Markus G. Manz,et al.  Development of a Human Adaptive Immune System in Cord Blood Cell-Transplanted Mice , 2004, Science.

[50]  T. Geijtenbeek,et al.  Self- and nonself-recognition by C-type lectins on dendritic cells. , 2004, Annual review of immunology.

[51]  R. Steinman,et al.  In Vivo Targeting of Antigens to Maturing Dendritic Cells via the DEC-205 Receptor Improves T Cell Vaccination , 2004, The Journal of experimental medicine.

[52]  S. Holmes,et al.  An in vitro human cell-based assay to rank the relative immunogenicity of proteins. , 2004, Toxicological sciences : an official journal of the Society of Toxicology.

[53]  M. Daëron,et al.  Fc receptor biology. , 2003, Annual review of immunology.

[54]  S. Holmes,et al.  Human population-based identification of CD4(+) T-cell peptide epitope determinants. , 2003, Journal of immunological methods.

[55]  T. de Ståhl,et al.  A Role for Complement in Feedback Enhancement of Antibody Responses by IgG3 , 2003, The Journal of experimental medicine.

[56]  A. Haselbeck Epoetins: differences and their relevance to immunogenicity , 2003, Current medical research and opinion.

[57]  Petra Lenz,et al.  Determinants of Autoantibody Induction by Conjugated Papillomavirus Virus-Like Particles , 2002, The Journal of Immunology.

[58]  A. Mire-Sluis,et al.  Immune responses to therapeutic proteins in humans--clinical significance, assessment and prediction. , 2002, Current pharmaceutical biotechnology.

[59]  J. Murray,et al.  HLA-DQ Determines the Response to Exogenous Wheat Proteins: A Model of Gluten Sensitivity in Transgenic Knockout Mice1 , 2002, The Journal of Immunology.

[60]  E. Wiertz,et al.  Viral immune evasion: a masterpiece of evolution , 2002, Immunogenetics.

[61]  M. Reding,et al.  Distribution of Th1- and Th2-induced Anti-factor VIII IgG Subclasses in Congenital and Acquired Hemophilia Patients , 2002, Thrombosis and Haemostasis.

[62]  P. Carrieri,et al.  van Swieten’s concept of cerebral embolic stroke , 2002, Journal of neurology, neurosurgery, and psychiatry.

[63]  Patrick Mayeux,et al.  Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin. , 2002, The New England journal of medicine.

[64]  R. Zubler Naive and memory B cells in T-cell-dependent and T-independent responses , 2001, Springer Seminars in Immunopathology.

[65]  A. Nissenson Novel erythropoiesis stimulating protein for managing the anemia of chronic kidney disease. , 2001, American journal of kidney diseases : the official journal of the National Kidney Foundation.

[66]  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.

[67]  S. Cook,et al.  Serum IFN neutralizing antibodies and neopterin levels in a cross-section of MS patients , 2001, Neurology.

[68]  R. Kiessling,et al.  DNA immunization of HLA transgenic mice with a plasmid expressing mycobacterial heat shock protein 65 results in HLA class I- and II-restricted T cell responses that can be augmented by cytokines. , 2001, Human gene therapy.

[69]  L. Old,et al.  Serological analysis of human anti-human antibody responses in colon cancer patients treated with repeated doses of humanized monoclonal antibody A33. , 2001, Cancer research.

[70]  C Crimi,et al.  Optimization of epitope processing enhances immunogenicity of multiepitope DNA vaccines. , 2001, Vaccine.

[71]  J. Kearney,et al.  Marginal zone and B1 B cells unite in the early response against T-independent blood-borne particulate antigens. , 2001, Immunity.

[72]  A. Lucas,et al.  Increased Immunogenicity and Induction of Class Switching by Conjugation of Complement C3d to Pneumococcal Serotype 14 Capsular Polysaccharide , 2001, Infection and Immunity.

[73]  D. Podolsky,et al.  Mucosal antigen presentation and the control of tolerance and immunity. , 2001, Trends in immunology.

[74]  D. Jäger,et al.  Challenges to the development of antigen-specific breast cancer vaccines , 2001, Breast Cancer Research.

[75]  B. Heyman,et al.  Antibody Production in Mice Deficient for Complement Receptors 1 and 2 Can Be Induced by IgG/Ag and IgE/Ag, But Not IgM/Ag Complexes1 , 2000, The Journal of Immunology.

[76]  M. Clark,et al.  Antibody humanization: a case of the 'Emperor's new clothes'? , 2000, Immunology today.

[77]  C. Snapper,et al.  B‐cell activation by T‐cell‐independent type 2 antigens as an integral part of the humoral immune response to pathogenic microorganisms , 2000, Immunological reviews.

[78]  R. G. Das,et al.  Neutralizing antibodies to granulocyte–macrophage colony‐stimulating factor, interleukin‐1α and interferon‐α but not other cytokines in human immunoglobulin preparations , 2000 .

[79]  Horst Schwinn,et al.  Degradation Products of Factor VIII Which Can Lead to Increased Immunogenicity , 1999, Vox Sanguinis.

[80]  G Y Ishioka,et al.  Utilization of MHC class I transgenic mice for development of minigene DNA vaccines encoding multiple HLA-restricted CTL epitopes. , 1999, Journal of immunology.

[81]  C. David,et al.  HLA-DR4 (DRB1*0401) transgenic mice expressing an altered CD4-binding site: specificity and magnitude of DR4-restricted T cell response. , 1998, Journal of immunology.

[82]  Christoph Schaniel,et al.  Rapid and coordinated switch in chemokine receptor expression during dendritic cell maturation , 1998, European journal of immunology.

[83]  R. Holmdahl,et al.  Epitope glycosylation plays a critical role for T cell recognition of type II collagen in collagen‐induced arthritis , 1998, European journal of immunology.

[84]  M. Billeter,et al.  T-cell independent IgM and enduring protective IgG antibodies induced by chimeric measles viruses , 1998, Nature Medicine.

[85]  M F del Guercio,et al.  Several common HLA-DR types share largely overlapping peptide binding repertoires. , 1998, Journal of immunology.

[86]  T. So,et al.  Depression of T-cell Epitope Generation by Stabilizing Hen Lysozyme* , 1997, The Journal of Biological Chemistry.

[87]  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.

[88]  M. Plebanski,et al.  Genetic analysis of host-parasite coevolution in human malaria. , 1997, Philosophical transactions of the Royal Society of London. Series B, Biological sciences.

[89]  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.

[90]  Ryff Jc,et al.  Clinical investigation of the immunogenicity of interferon-alpha 2a. , 1997 .

[91]  R. Zinkernagel,et al.  Role of Repetitive Antigen Patterns for Induction of Antibodies Against Antibodies , 1997, The Journal of experimental medicine.

[92]  S S Prabhakar,et al.  Antibodies to recombinant human erythropoietin causing pure red cell aplasia. , 1997, Clinical nephrology.

[93]  A. Woods,et al.  An HLA-DR1 Transgene Confers Susceptibility to Collagen-induced Arthritis Elicited with Human Type II Collagen , 1997, The Journal of experimental medicine.

[94]  M. Moser,et al.  Regulation of dendritic cell numbers and maturation by lipopolysaccharide in vivo , 1996, The Journal of experimental medicine.

[95]  G. Hämmerling,et al.  HLA-DRB1 polymorphism determines susceptibility to autoimmune thyroiditis in transgenic mice: definitive association with HLA- DRB1*0301 (DR3) gene , 1996, The Journal of experimental medicine.

[96]  D. Scott,et al.  Epitope-specific tolerance induction with an engineered immunoglobulin. , 1996, Proceedings of the National Academy of Sciences of the United States of America.

[97]  V. Engelhard,et al.  Definition of a human T cell epitope from influenza A non-structural protein 1 using HLA-A2.1 transgenic mice. , 1995, International immunology.

[98]  J. Berzofsky,et al.  CTL responses of HLA-A2.1-transgenic mice specific for hepatitis C viral peptides predict epitopes for CTL of humans carrying HLA-A2.1. , 1995, Journal of immunology.

[99]  D. Weilguny,et al.  The potential immunogenicity of human insulin and insulin analogues evaluated in a transgenic mouse model , 1994, Diabetologia.

[100]  H. Heimpel,et al.  Roferon (rIFN-α2a) Is More Immunogenic Than Intron A (rIFN-α2b) in Patients with Chronic Myelogenous Leukemia , 1994 .

[101]  R M Zinkernagel,et al.  How many specific B cells are needed to protect against a virus? , 1994, Journal of immunology.

[102]  M. Nussenzweig,et al.  A 13-amino-acid motif in the cytoplasmic domain of FcγRIIB modulates B-cell receptor signalling , 1994, Nature.

[103]  R. Zinkernagel,et al.  The influence of antigen organization on B cell responsiveness. , 1993, Science.

[104]  F. Rosendaal,et al.  Factor VIII inhibitors , 1993, The Lancet.

[105]  Hoyer Lw Factor VIII inhibitors: a continuing problem. , 1993, The Journal of laboratory and clinical medicine.

[106]  W. Fridman,et al.  Cytoplasmic domain heterogeneity and functions of IgG Fc receptors in B lymphocytes. , 1992, Science.

[107]  W. Kreuz,et al.  Incidence of development of factor VIII and factor IX inhibitors in haemophiliacs , 1992, The Lancet.

[108]  A. Müllbacher Viral escape from immune recognition: Multiple strategies of adenoviruses , 1992, Immunology and cell biology.

[109]  R. Tamura,et al.  Comparison of the immunogenicity of recombinant and pituitary human growth hormone in rhesus monkeys. , 1991, Fundamental and applied toxicology : official journal of the Society of Toxicology.

[110]  L. Martin,et al.  Transgenic mice as a model to test the immunogenicity of proteins altered by site-specific mutagenesis. , 1989, Molecular biology & medicine.

[111]  P. Marrack,et al.  T cell tolerance by clonal elimination in the thymus , 1987, Cell.

[112]  A. Bristow,et al.  Detection of host‐derived contaminants in products of recombinant DNA technology in E. coli: a comparison of silver‐staining and immunoblotting , 1985, The Journal of pharmacy and pharmacology.

[113]  G. Klaus Generation of memory cells. III. Antibody class requirements for the generation of B-memory cells by antigen--antibody complexes. , 1979, Immunology.

[114]  F. Carr,et al.  Deimmunization of monoclonal antibodies. , 2009, Methods in molecular biology.

[115]  S. Diebold Activation of dendritic cells by toll-like receptors and C-type lectins. , 2009, Handbook of experimental pharmacology.

[116]  J. Vielmetter,et al.  Clinical link between MHC class II haplotype and interferon-beta (IFN-beta) immunogenicity. , 2006, Clinical immunology.

[117]  W. Martin,et al.  De-immunization of therapeutic proteins by T-cell epitope modification. , 2005, Developments in biologicals.

[118]  B. Diamond Speculations on the immunogenicity of self proteins. , 2003, Developments in biologicals.

[119]  Rosenberg As Immunogenicity of biological therapeutics: a hierarchy of concerns. , 2003, Developments in biologicals.

[120]  J. Tcheng,et al.  Consequences of immunogenicity to the therapeutic monoclonal antibodies ReoPro and Remicade. , 2003, Developments in biologicals.

[121]  R. Zinkernagel,et al.  Neutralizing antiviral B cell responses. , 1997, Annual review of immunology.

[122]  T. So,et al.  Reduced immunogenicity of monomethoxypolyethylene glycol-modified lysozyme for activation of T cells. , 1996, Immunology letters.

[123]  C. Janeway Approaching the asymptote? Evolution and revolution in immunology. , 1989, Cold Spring Harbor symposia on quantitative biology.

[124]  P. Coulie,et al.  Enhancement of IgG anti‐carrier responses by IgG2 anti‐hapten antibodies in mice , 1985, European journal of immunology.