Immunogenicity Considerations for Therapeutic Modalities Used in Rare Diseases

Enhanced Infiltration of Central Memory T Cells to the Lung Tissue during Allergic Lung Inflammation

(2021) Mashael Alabed et al.   INTERNATIONAL ARCHIVES OF ALLERGY AND IMMUNOLOGY

From innate to adaptive immunity: Abomasal transcriptomic responses of merino sheep to Haemonchus contortus infection

(2021) Jing Liu et al.   MOLECULAR AND BIOCHEMICAL PARASITOLOGY

Toxicity and immunogenicity concerns related to PEGylated-micelle carrier systems: a review

(2019) Kouichi Shiraishi et al.   SCIENCE AND TECHNOLOGY OF ADVANCED MATERIALS

Recommendations for the Development and Validation of Immunogenicity Assays in Support of Biosimilar Programs

(2019) Francesca Civoli et al.   AAPS Journal

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

(2019) Steven Piccoli et al.   Bioanalysis

Reporting, Visualization, and Modeling of Immunogenicity Data to Assess Its Impact on Pharmacokinetics, Efficacy, and Safety of Monoclonal Antibodies

(2018) Chaitali Passey et al.   AAPS Journal

Immunogenicity of Protein Pharmaceuticals

(2018) Robert Dingman et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Perspectives on Subcutaneous Route of Administration as an Immunogenicity Risk Factor for Therapeutic Proteins

(2017) Lora Hamuro et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Assessing the Immunogenicity of Biopharmaceuticals

(2016) Carlos Pineda et al.   BIODRUGS

In situexpansion of T cells that recognize distinct self-antigens sustains autoimmunity in the CNS

(2016) Abdulraouf Ramadan et al.   BRAIN

Evaluating and Reporting the Immunogenicity Impacts for Biological Products—a Clinical Pharmacology Perspective

(2015) Yow-Ming C. Wang et al.   AAPS Journal

B Cells, Antibodies, and More

(2015) W. Hoffman et al.   Clinical Journal of the American Society of Nephrology

The Effect of Small Oligomeric Protein Aggregates on the Immunogenicity of Intravenous and Subcutaneous Administered Antibodies

(2015) Anas M. Fathallah et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Various Forms of Tissue Damage and Danger Signals Following Hematopoietic Stem-Cell Transplantation

(2015) Abdulraouf Ramadan et al.   Frontiers in Immunology

Review on modeling anti-antibody responses to monoclonal antibodies

(2014) José David Gómez-Mantilla et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

Immunogenicity of Subcutaneously Administered Therapeutic Proteins—a Mechanistic Perspective

(2013) Anas M. Fathallah et al.   AAPS Journal

Broadly cross-reactive antibodies dominate the human B cell response against 2009 pandemic H1N1 influenza virus infection

(2011) Jens Wrammert et al.   JOURNAL OF EXPERIMENTAL MEDICINE

Peripheral CD4+ T-cell differentiation regulated by networks of cytokines and transcription factors

(2010) Jinfang Zhu et al.   IMMUNOLOGICAL REVIEWS

Progress and prospects: immune responses to viral vectors

(2009) S Nayak et al.   GENE THERAPY

Recognition of 5′ Triphosphate by RIG-I Helicase Requires Short Blunt Double-Stranded RNA as Contained in Panhandle of Negative-Strand Virus

(2009) Martin Schlee et al.   IMMUNITY

CD137 Promotes Proliferation and Survival of Human B Cells

(2009) X. Zhang et al.   JOURNAL OF IMMUNOLOGY

Conditional modeling of antibody titers using a zero-inflated poisson random effects model: application to Fabrazyme®

(2009) Peter L. Bonate et al.   JOURNAL OF PHARMACOKINETICS AND PHARMACODYNAMICS

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

(2008) Eugen Koren et al.   JOURNAL OF IMMUNOLOGICAL METHODS

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

(2008) Gopi Shankar et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS