Detection of innate immune response modulating impurities (IIRMI) in therapeutic peptides and proteins: Impact of excipients

Use of in vitro human skin models to assess potential immune activation in response to biotherapeutic attributes and process-related impurities

(2022) Joshua M. Tokuda et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

An in vitro study on factors affecting endotoxin neutralization in human plasma using the Limulus amebocyte lysate test

(2021) Stephan Harm et al.   Scientific Reports

Biphasic anaphylaxis after first dose of messenger RNA coronavirus disease 2019 vaccine with positive polysorbate 80 skin testing result

(2021) Mitchell M. Pitlick et al.   ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY

Cathelicidin and PMB neutralize endotoxins by multifactorial mechanisms including LPS interaction and targeting of host cell membranes

(2021) Andra B. Schromm et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

An In Vitro Assessment of Immunostimulatory Responses to Ten Model Innate Immune Response Modulating Impurities (IIRMIs) and Peptide Drug Product, Teriparatide

(2021) Claire K. Holley et al.   MOLECULES

Effect of Fatty Acid Composition in Polysorbate 80 on the Stability of Therapeutic Protein Formulations

(2021) Melissa A. Pegues et al.   PHARMACEUTICAL RESEARCH

Factor VIII: Perspectives on Immunogenicity and Tolerogenic Strategies

(2020) David W. Scott et al.   Frontiers in Immunology

Biologic excipients: Importance of clinical awareness of inactive ingredients

(2020) Yelena Ionova et al.   PLoS One

A Comprehensive Scientific Survey of Excipients Used in Currently Marketed, Therapeutic Biological Drug Products

(2020) V. Ashutosh Rao et al.   PHARMACEUTICAL RESEARCH

The Impact of Product and Process Related Critical Quality Attributes on Immunogenicity and Adverse Immunological Effects of Biotherapeutics

(2020) Yi Wen et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Immunological Evaluation In Vitro of Nanoparticulate Impurities Isolated From Pharmaceutical-Grade Sucrose

(2020) Adam Grabarek et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Impact of Precipitation of Antibody Therapeutics After Subcutaneous Injection on Pharmacokinetics and Immunogenicity

(2019) Francis Kinderman et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Low Endotoxin Recovery—Masking of Naturally Occuring Endotoxin

(2019) Johannes Reich et al.   INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Multiplexed Gene Expression as a Characterization of Bioactivity for Interferon Beta (IFN-β) Biosimilar Candidates: Impact of Innate Immune Response Modulating Impurities (IIRMIs)

(2019) Eduardo F. Mufarrege et al.   AAPS Journal

NF-κB Signaling in Macrophages: Dynamics, Crosstalk, and Signal Integration

(2019) Michael G. Dorrington et al.   Frontiers in Immunology

Xolair-induced recurrent anaphylaxis through sensitization to the excipient polysorbate

(2018) Emilie Perino et al.   ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY

Regulation of the Cell Biology of Antigen Cross-Presentation

(2018) J. Magarian Blander   Annual Review of Immunology

Are Injection Site Reactions in Monoclonal Antibody Therapies Caused by Polysorbate Excipient Degradants?

(2018) Satish K. Singh et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Aggregates of IVIG or Avastin, but not HSA, modify the response to model innate immune response modulating impurities

(2018) Swamy Kumar Polumuri et al.   Scientific Reports

Anaphylaxis Due to Poloxamer 238

(2018) A Carbonell et al.   JOURNAL OF INVESTIGATIONAL ALLERGOLOGY AND CLINICAL IMMUNOLOGY

In Vivo Effect of Innate Immune Response Modulating Impurities on the Skin Milieu Using a Macaque Model: Impact on Product Immunogenicity

(2017) Lydia A. Haile et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Immunogenicity and loss of response to TNF inhibitors: implications for rheumatoid arthritis treatment

(2017) Joachim R. Kalden et al.   Nature Reviews Rheumatology

Lipid-Reduction Variability and Antidrug-Antibody Formation with Bococizumab

(2017) Paul M Ridker et al.   NEW ENGLAND JOURNAL OF MEDICINE

Biological Activity of Masked Endotoxin

(2017) Harald Schwarz et al.   Scientific Reports

Endotoxin recovery using limulus amebocyte lysate (LAL) assay

(2016) Jay S. Bolden et al.   BIOLOGICALS

Masking of endotoxin in surfactant samples: Effects on Limulus-based detection systems

(2016) Johannes Reich et al.   BIOLOGICALS

Age-Specific Adjuvant Synergy: Dual TLR7/8 and Mincle Activation of Human Newborn Dendritic Cells Enables Th1 Polarization

(2016) Simon D. van Haren et al.   JOURNAL OF IMMUNOLOGY

Immunogenicity of Therapeutic Protein Aggregates

(2016) Ehab M. Moussa et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Physical Characterization and Innate Immunogenicity of Aggregated Intravenous Immunoglobulin (IGIV) in an In Vitro Cell-Based Model

(2016) E. M. Moussa et al.   PHARMACEUTICAL RESEARCH

Host cell proteins in biotechnology-derived products: A risk assessment framework

(2015) Christina L. Zuch de Zafra et al.   BIOTECHNOLOGY AND BIOENGINEERING

Changes in the amino acid sequence of the recombinant human factor VIIa analog, vatreptacog alfa, are associated with clinical immunogenicity

(2015) J. N. Mahlangu et al.   JOURNAL OF THROMBOSIS AND HAEMOSTASIS

Nanoparticulate Impurities in Pharmaceutical-Grade Sugars and their Interference with Light Scattering-Based Analysis of Protein Formulations

(2015) Daniel Weinbuch et al.   PHARMACEUTICAL RESEARCH

Detection of Innate Immune Response Modulating Impurities in Therapeutic Proteins

(2015) Lydia Asrat Haile et al.   PLoS One

Molecular Control of Steady-State Dendritic Cell Maturation and Immune Homeostasis

(2013) Gianna Elena Hammer et al.   Annual Review of Immunology

Low pH Environmental Stress Inhibits LPS and LTA-Stimulated Proinflammatory Cytokine Production in Rat Alveolar Macrophages

(2013) Stanley F. Fernandez et al.   Biomed Research International

Managing uncertainty: A perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins

(2012) Amy S. Rosenberg et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Biologic-induced urticaria due to polysorbate 80: usefulness of prick test

(2011) L. Pérez-Pérez et al.   BRITISH JOURNAL OF DERMATOLOGY

Programming the magnitude and persistence of antibody responses with innate immunity

(2011) Sudhir Pai Kasturi et al.   NATURE

Tungsten-Induced Denaturation and Aggregation of Epoetin Alfa During Primary Packaging as a Cause of Immunogenicity

(2011) Andreas Seidl et al.   PHARMACEUTICAL RESEARCH

Trace Levels of Innate Immune Response Modulating Impurities (IIRMIs) Synergize to Break Tolerance to Therapeutic Proteins

(2010) Daniela Verthelyi et al.   PLoS One

Multiple signaling pathways contribute to synergistic TLR ligand-dependent cytokine gene expression in human monocyte-derived macrophages and dendritic cells

(2009) S. M. Makela et al.   JOURNAL OF LEUKOCYTE BIOLOGY

Tungsten-induced protein aggregation: Solution behavior

(2009) Yijia Jiang et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

NOD-Like Receptors: Role in Innate Immunity and Inflammatory Disease

(2008) Grace Chen et al.   Annual Review of Pathology-Mechanisms of Disease

Cetuximab-Induced Anaphylaxis and IgE Specific for Galactose-α-1,3-Galactose

(2008) Christine H. Chung et al.   NEW ENGLAND JOURNAL OF MEDICINE