Physical Characterization and Innate Immunogenicity of Aggregated Intravenous Immunoglobulin (IGIV) in an In Vitro Cell-Based Model
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journal
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April 2016 |
Hypersensitivity Reaction to Mannitol
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July 1985 |
Masking of endotoxin in surfactant samples: Effects on Limulus-based detection systems
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September 2016 |
Effects of protein aggregates: An immunologic perspective
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September 2006 |
Xolair-induced recurrent anaphylaxis through sensitization to the excipient polysorbate
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June 2018 |
Anaphylactic Reaction to Mannitol
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November 1967 |
Impact of Precipitation of Antibody Therapeutics After Subcutaneous Injection on Pharmacokinetics and Immunogenicity
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June 2019 |
Host cell proteins in biotechnology-derived products: A risk assessment framework
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June 2015 |
Electrodialysis of Lipopolysaccharides and Their Conversion to Uniform Salt Forms
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June 1975 |
An in vitro study on factors affecting endotoxin neutralization in human plasma using the Limulus amebocyte lysate test
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February 2021 |
Factor VIII: Perspectives on Immunogenicity and Tolerogenic Strategies
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January 2020 |
Hypersensitivity reactions to the polysorbate contained in recombinant erythropoietin and darbepoietin (Case Report)
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journal
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June 2005 |
Use of In Vitro Human Skin Models to Assess Potential Immune Activation In Response to Biotherapeutic Attributes and Process-related Impurities
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April 2022 |
Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab
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April 2017 |
Cathelicidin and PMB neutralize endotoxins by multifactorial mechanisms including LPS interaction and targeting of host cell membranes
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June 2021 |
Effect of Fatty Acid Composition in Polysorbate 80 on the Stability of Therapeutic Protein Formulations
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November 2021 |
Managing uncertainty: A perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins
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October 2012 |
Tungsten-Induced Denaturation and Aggregation of Epoetin Alfa During Primary Packaging as a Cause of Immunogenicity
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November 2011 |
Longitudinal analyses of the effects of neutralizing antibodies on interferon beta-1b in relapsing-remitting multiple sclerosis
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April 2004 |
Immunological Evaluation In Vitro of Nanoparticulate Impurities Isolated From Pharmaceutical-Grade Sucrose
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February 2021 |
Immunogenicity and loss of response to TNF inhibitors: implications for rheumatoid arthritis treatment
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November 2017 |
The Impact of Product and Process Related Critical Quality Attributes on Immunogenicity and Adverse Immunological Effects of Biotherapeutics
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March 2021 |
Aggregates of IVIG or Avastin, but not HSA, modify the response to model innate immune response modulating impurities
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journal
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July 2018 |
TLRs, NLRs and RLRs: a trinity of pathogen sensors that co-operate in innate immunity
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journal
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August 2006 |
Biphasic anaphylaxis after first dose of messenger RNA coronavirus disease 2019 vaccine with positive polysorbate 80 skin testing result
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October 2021 |
Use of XTT-assay to assess the cytotoxicity of different surfactants and metal salts in human keratinocytes (HaCaT). A feasible method for in vitro testing of skin irritants.
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January 1997 |
Low pH Environmental Stress Inhibits LPS and LTA-Stimulated Proinflammatory Cytokine Production in Rat Alveolar Macrophages
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January 2013 |
Nanoparticulate Impurities in Pharmaceutical-Grade Sugars and their Interference with Light Scattering-Based Analysis of Protein Formulations
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journal
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January 2015 |
In vitro basophil histamine release induced by mannitol in a patient with a mannitol-induced anaphylactoid reaction
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May 1984 |
Endotoxin recovery using limulus amebocyte lysate (LAL) assay
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journal
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September 2016 |
Recognition and Signaling by Toll-Like Receptors
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journal
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November 2006 |
Age-Specific Adjuvant Synergy: Dual TLR7/8 and Mincle Activation of Human Newborn Dendritic Cells Enables Th1 Polarization
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December 2016 |
Immunogenicity risk assessment for biotherapeutics through in vitro detection of CD134 and CD137 on T helper cells
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January 2021 |
Pure Red-Cell Aplasia and Antierythropoietin Antibodies in Patients Treated with Recombinant Erythropoietin
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February 2002 |
Evidence Against a Bacterial Endotoxin Masking Effect in Biologic Drug Products by Limulus Amebocyte Lysate Detection
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journal
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September 2014 |
A Comprehensive Scientific Survey of Excipients Used in Currently Marketed, Therapeutic Biological Drug Products
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journal
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September 2020 |
Dithiothreitol has a dose-response effect on cell surface antigen expression
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May 1999 |
Multiple signaling pathways contribute to synergistic TLR ligand-dependent cytokine gene expression in human monocyte-derived macrophages and dendritic cells
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January 2009 |
Changes in the amino acid sequence of the recombinant human factor VIIa analog, vatreptacog alfa, are associated with clinical immunogenicity
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October 2015 |
An In Vitro Assessment of Immunostimulatory Responses to Ten Model Innate Immune Response Modulating Impurities (IIRMIs) and Peptide Drug Product, Teriparatide
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December 2021 |
Detection of Innate Immune Response Modulating Impurities in Therapeutic Proteins
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journal
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April 2015 |
Immunogenicity of Therapeutic Protein Aggregates
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journal
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February 2016 |
Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose
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journal
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March 2008 |
Anaphylaxis Due to Poloxamer 238
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journal
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December 2018 |
An allergic reaction to erythropoietin secondary to polysorbate hypersensitivity
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journal
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September 2002 |
Flow-cytometric analysis on adverse effects of polysorbate 80 in rat thymocytes
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July 2004 |
In Vivo Effect of Innate Immune Response Modulating Impurities on the Skin Milieu Using a Macaque Model: Impact on Product Immunogenicity
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March 2017 |
Programming the magnitude and persistence of antibody responses with innate immunity
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February 2011 |
Regulation of the Cell Biology of Antigen Cross-Presentation
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April 2018 |
Multiplexed Gene Expression as a Characterization of Bioactivity for Interferon Beta (IFN-β) Biosimilar Candidates: Impact of Innate Immune Response Modulating Impurities (IIRMIs)
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February 2019 |
NF-κB Signaling in Macrophages: Dynamics, Crosstalk, and Signal Integration
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April 2019 |
Molecular Control of Steady-State Dendritic Cell Maturation and Immune Homeostasis
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March 2013 |
NOD-Like Receptors: Role in Innate Immunity and Inflammatory Disease
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journal
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February 2009 |
Trace Levels of Innate Immune Response Modulating Impurities (IIRMIs) Synergize to Break Tolerance to Therapeutic Proteins
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December 2010 |
Low Endotoxin Recovery—Masking of Naturally Occuring Endotoxin
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journal
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February 2019 |
Materials in Manufacturing and Packaging Systems as Sources of Elemental Impurities in Packaged Drug Products: A Literature Review
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January 2015 |
Biologic-induced urticaria due to polysorbate 80: usefulness of prick test
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April 2011 |
Biologic excipients: Importance of clinical awareness of inactive ingredients
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June 2020 |
Tungsten-induced protein aggregation: Solution behavior
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journal
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December 2009 |
Are Injection Site Reactions in Monoclonal Antibody Therapies Caused by Polysorbate Excipient Degradants?
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journal
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November 2018 |
Biological Activity of Masked Endotoxin
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March 2017 |