Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies (Q44957871)

7 December 2017

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies (English)

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7 December 2017

17

Peter Thomas

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7 December 2017

Rafael Ponce

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7 December 2017

Leslie Abad

2

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7 December 2017

Lakshmi Amaravadi

3

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7 December 2017

Thomas Gelzleichter

4

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7 December 2017

Elizabeth Gore

5

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7 December 2017

James Green

6

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7 December 2017

Shalini Gupta

7

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7 December 2017

Danuta Herzyk

8

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7 December 2017

Christopher Hurst

9

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7 December 2017

Inge A Ivens

10

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7 December 2017

Thomas Kawabata

11

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7 December 2017

Curtis Maier

12

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7 December 2017

Barbara Mounho

13

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7 December 2017

Bonita Rup

14

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7 December 2017

Gopi Shankar

15

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7 December 2017

Holly Smith

16

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7 December 2017

Dan Wierda

18

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7 December 2017

language of work or name

English

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publication date

2 April 2009

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Regulatory Toxicology and Pharmacology

7 December 2017

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7 December 2017

54

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7 December 2017

2

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7 December 2017

164-182

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Origin of regulatory T cells with known specificity for antigen

7 December 2017

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Levels of peripheral T cell tolerance

7 January 2021

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Basic aspects of inhibitors to factors VIII and IX and the influence of non-genetic risk factors

7 January 2021

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Antibody-mediated enhancement of hormone activity

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Production and clinical development of a Hansenula polymorpha-derived PEGylated hirudin.

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Influence of Immunogenicity on the Long-Term Efficacy of Infliximab in Crohn's Disease

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Clinical link between MHC class II haplotype and interferon-beta (IFN-beta) immunogenicity.

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Structure-function engineering of interferon-beta-1b for improving stability, solubility, potency, immunogenicity, and pharmacokinetic properties by site-selective mono-PEGylation

7 January 2021

1 reference

https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-alpha) in normal and transgenic mice

7 January 2021

1 reference

https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Preclinical development of keliximab, a Primatized anti-CD4 monoclonal antibody, in human CD4 transgenic mice: characterization of the model and safety studies.

7 January 2021

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Epoetin-induced autoimmune pure red cell aplasia

7 January 2021

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Pure red-cell aplasia and antierythropoietin antibodies in patients treated with recombinant erythropoietin

7 January 2021

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Peripheral deletion of antigen-reactive T cells in oral tolerance.

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Regulatory T cell clones induced by oral tolerance: suppression of autoimmune encephalomyelitis

7 January 2021

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Characterizing biological products and assessing comparability following manufacturing changes.

7 January 2021

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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

7 January 2021

1 reference

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The rhGM-CSF-EPO hybrid protein MEN 11300 induces anti-EPO antibodies and severe anaemia in rhesus monkeys

7 January 2021

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Monoclonal antibody clearance. Impact of modulating the interaction of IgG with the neonatal Fc receptor

7 January 2021

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Activation of natural regulatory T cells by IgG Fc-derived peptide "Tregitopes"

7 January 2021

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Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates

7 January 2021

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Pharmacokinetics and microdistribution of polyethylene glycol-modified humanized A33 antibody targeting colon cancer xenografts

7 January 2021

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Post-translational protein modifications in antigen recognition and autoimmunity

7 January 2021

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Genetic induction of immune tolerance to human clotting factor VIII in a mouse model for hemophilia A

7 January 2021

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Small B cells as antigen-presenting cells in the induction of tolerance to soluble protein antigens

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Immunologic effects of insulin lispro [Lys (B28), Pro (B29) human insulin] in IDDM and NIDDM patients previously treated with insulin

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Induction of anergy or active suppression following oral tolerance is determined by antigen dosage.

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

B cells turn off virgin but not memory T cells

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

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

7 January 2021

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Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Pure red-cell aplasia and recombinant erythropoietin

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

The IgG Fc receptor family

7 January 2021

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The need for central and peripheral tolerance in the B cell repertoire

7 January 2021

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Improving the therapeutic efficacy of peptides and proteins: a role for polysialic acids

7 January 2021

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Toxicity as a result of immunostimulation by biologics

7 January 2021

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Immunogenicity of recombinant human interleukin-3

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Reducing the immunogenicity and improving the in vivo activity of trichosanthin by site-directed pegylation.

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Cross-presentation, dendritic cells, tolerance and immunity

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Preclinical safety of recombinant human thrombin

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Single-cell dynamics of T-cell priming

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Preclinical safety of recombinant human interleukin-18

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Immunopharmacology of recombinant human interleukin-18 in non-human primates

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Altered humoral immunity during pregnancy in the guinea pig

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Central tolerance: learning self-control in the thymus

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Activation of APCs through CD40 or Toll-like receptor 9 overcomes tolerance and precipitates autoimmune disease

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Assessment of the immunogenicity of different interferon beta-1a formulations using ex vivo T-cell assays

7 January 2021

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The Rebif new formulation story: it's not trials and error

7 January 2021

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High-dose recombinant interleukin-18 induces an effective Th1 immune response to murine MOPC-315 plasmacytoma

7 January 2021

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Studying immunological tolerance by physically monitoring antigen-specific T cells in vivo

7 January 2021

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Application of analytical detection concepts to immunogenicity testing

7 January 2021

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Immunoinformatics comes of age

7 January 2021

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Clinical validation of the "in silico" prediction of immunogenicity of a human recombinant therapeutic protein.

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Immune responses to therapeutic proteins in humans--clinical significance, assessment and prediction

7 January 2021

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Regulatory T cell suppression and anergy are differentially regulated by proinflammatory cytokines produced by TLR-activated dendritic cells

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Dendritic cells are sufficient to cross-present self-antigens to CD8 T cells in vivo

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Major histocompatibility complex class I-restricted cross-presentation is biased towards high dose antigens and those released during cellular destruction

7 January 2021

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The use of PEG-rhuMGDF in platelet apheresis

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

The clinical use and immunologic impact of thrombin in surgery

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Thrombocytopenia caused by the development of antibodies to thrombopoietin

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Intravenous injection of soluble antigen induces thymic and peripheral T-cells apoptosis.

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

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

7 January 2021

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Immature, but not inactive: the tolerogenic function of immature dendritic cells

7 January 2021

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Isoaspartyl post-translational modification triggers autoimmune responses to self-proteins

7 January 2021

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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

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

The HLA-A*0201-restricted H-Y antigen contains a posttranslationally modified cysteine that significantly affects T cell recognition

7 January 2021

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Induction of tolerance to recombinant therapeutic proteins

7 January 2021

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https://api.crossref.org/works/10.1016%2FJ.YRTPH.2009.03.012

Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

7 January 2021

1 reference

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Tissue transglutaminase selectively modifies gliadin peptides that are recognized by gut-derived T cells in celiac disease.

7 January 2021

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The anatomy of T-cell activation and tolerance

7 January 2021

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Assessing immunogenicity in the presence of excess protein therapeutic using immunoprecipitation and quantitative mass spectrometry

7 January 2021

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Toll-like receptors: balancing host resistance with immune tolerance

7 January 2021

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Antibodies as carrier proteins

7 January 2021

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Effects of protein aggregates: an immunologic perspective

7 January 2021

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Glycosylation and the immune system

7 January 2021

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Neutralizing and binding antibodies to IFN-beta: relative frequency in relapsing-remitting multiple sclerosis patients treated with different IFN-beta preparations

7 January 2021

1 reference

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Safety assessment of biotechnology-derived pharmaceuticals: ICH and beyond

7 January 2021

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A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs

7 January 2021

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Scientific and regulatory considerations on the immunogenicity of biologics

7 January 2021

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Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

7 January 2021

1 reference

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Immunogenicity of therapeutic proteins. Part 3: impact of manufacturing changes

7 January 2021

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Improvement of drug tolerance in immunogenicity testing by acid treatment on Biacore

7 January 2021

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An HLA-A2-restricted tyrosinase antigen on melanoma cells results from posttranslational modification and suggests a novel pathway for processing of membrane proteins

7 January 2021

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Peptide-MHC potency governs dynamic interactions between T cells and dendritic cells in lymph nodes

7 January 2021

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Identification of natural antibodies to interleukin-18 in the sera of normal humans and three nonhuman primate species

7 January 2021

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The induction of tolerance by dendritic cells that have captured apoptotic cells

7 January 2021

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The HLA-DR2 haplotype is associated with an increased proliferative response to the immunodominant CD4(+) T-cell epitope in human interferon-beta

7 January 2021

1 reference

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Acquired FV inhibitors: a needless iatrogenic complication of bovine thrombin exposure

7 January 2021

1 reference

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Immune responses to dietary antigens: oral tolerance.

7 January 2021

1 reference

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Evaluation of methods to detect and characterize antibodies against recombinant human erythropoietin

7 January 2021

1 reference

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Development of a maturing T-cell-mediated immune response in patients with idiopathic Parkinson's disease receiving r-metHuGDNF via continuous intraputaminal infusion

7 January 2021

1 reference

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PEGylation, successful approach to drug delivery

7 January 2021

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Predominant autoantibody production by early human B cell precursors

7 January 2021

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CAMPATH-1H, a humanized monoclonal antibody, in refractory rheumatoid arthritis. An intravenous dose-escalation study

7 January 2021

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Immunogenicity of biopharmaceuticals in laboratory animals

7 January 2021

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Glycan-regulated antigen processing of a protein in the endoplasmic reticulum can uncover cryptic cytotoxic T cell epitopes

7 January 2021

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Constant rate of steady-state self-antigen trafficking from skin to regional lymph nodes.

7 January 2021

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Activation of CD25(+)CD4(+) regulatory T cells by oral antigen administration

7 January 2021

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10.1016/J.YRTPH.2009.03.012

7 January 2021

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DOI

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7 December 2017

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