Journal of Immunology Research

Recent Advances in Assessing Immunogenicity of Therapeutic Proteins: Impact on Biotherapeutic Development


Publishing date
15 Jul 2016
Status
Published
Submission deadline
26 Feb 2016

Lead Editor

1Genentech, South San Francisco, USA

2University of Southern California, Los Angeles, USA

3Biogen, Cambridge, USA

4UCB Pharma, Brussel, Belgium

5Regeneron Pharmaceuticals, Tarrytown, USA


Recent Advances in Assessing Immunogenicity of Therapeutic Proteins: Impact on Biotherapeutic Development

Description

Protein based therapeutics may elicit unwanted immune responses that produce neutralizing or nonneutralizing antitherapeutic antibodies (ATA) in patients. These antibodies often impact drug pharmacokinetics, clinical efficacy, and patient safety. Therefore, it is critical to detect antibody response and characterize ATA in both preclinical and clinical phase of development to assess immunogenicity risks. It is also important to study the triggers and causes of immunogenicity as well as predict immunogenicity in order to reduce the potential for immunogenicity during drug development. We invite authors to submit original research as well as review articles.

Potential topics include, but are not limited to:

  • Novel methods in immunogenicity testing and ATA characterization (i.e., neutralizing ability, domain mapping, ATA isotyping, and preexisting ATA) for preclinical and clinical studies
  • Study the underlying mechanism of antibody response and identify critical contributing factors (i.e., protein aggregation, impurity, and posttranslational modifications including glycosylation) related to biologics or patients
  • Animal models, in silico and in vitro assay systems that predict the immunogenicity of biologics
  • Challenges presented by molecular engineered features of biologics that affect or induce immunogenicity
  • Enhanced understanding of the impact of the ATA on study outcomes (i.e., PKPD, efficacy, and safety)

Articles

  • Special Issue
  • - Volume 2016
  • - Article ID 8141269
  • - Editorial

Recent Advances in Assessing Immunogenicity of Therapeutic Proteins: Impact on Biotherapeutic Development

Yanmei Lu | Leslie A. Khawli | ... | Michael A. Partridge
  • Special Issue
  • - Volume 2016
  • - Article ID 2342187
  • - Review Article

Unraveling the Effect of Immunogenicity on the PK/PD, Efficacy, and Safety of Therapeutic Proteins

Alison Smith | Hugh Manoli | ... | Frank-Peter Theil
  • Special Issue
  • - Volume 2016
  • - Article ID 9096059
  • - Research Article

SEC Based Method for Size Determination of Immune Complexes of Therapeutic Antibodies in Animal Matrix

Marta Boysen | Laura Schlicksupp | ... | Mario Richter
  • Special Issue
  • - Volume 2016
  • - Article ID 6262383
  • - Review Article

Emerging Technologies and Generic Assays for the Detection of Anti-Drug Antibodies

Michael A. Partridge | Shobha Purushothama | ... | Yanmei Lu
  • Special Issue
  • - Volume 2016
  • - Article ID 1485615
  • - Research Article

Storage Conditions of Conjugated Reagents Can Impact Results of Immunogenicity Assays

Robert J. Kubiak | Nancy Lee | ... | Wendy I. White
  • Special Issue
  • - Volume 2016
  • - Article ID 1298473
  • - Review Article

Immunogenicity of Biotherapeutics: Causes and Association with Posttranslational Modifications

Anshu Kuriakose | Narendra Chirmule | Pradip Nair
  • Special Issue
  • - Volume 2016
  • - Article ID 9248061
  • - Research Article

Immunogenicity Assessment of Lipegfilgrastim in Patients with Breast Cancer Receiving Chemotherapy

Linglong Zou | Anton Buchner | ... | Patrick M. Liu
  • Special Issue
  • - Volume 2016
  • - Article ID 2921758
  • - Research Article

Preexisting Antibodies to an F(ab′)2 Antibody Therapeutic and Novel Method for Immunogenicity Assessment

Jane Ruppel | Ann Brady | ... | Eric Wakshull
  • Special Issue
  • - Volume 2016
  • - Article ID 5715790
  • - Research Article

Identification of Novel Vaccine Candidates against Campylobacter through Reverse Vaccinology

Marine Meunier | Muriel Guyard-Nicodème | ... | Daniel Dory
  • Special Issue
  • - Volume 2016
  • - Article ID 3072586
  • - Review Article

Understanding the Supersensitive Anti-Drug Antibody Assay: Unexpected High Anti-Drug Antibody Incidence and Its Clinical Relevance

Sam Song | Lili Yang | ... | Timothy Wyant
Journal of Immunology Research
 Journal metrics
Acceptance rate40%
Submission to final decision64 days
Acceptance to publication30 days
CiteScore3.330
Impact Factor3.404
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