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Prediction of immunogenicity: in silico paradigms, ex vivo and in vivo correlates
Abstract
Immunogenicity can be a major obstacle to successful protein drug therapy. Antidrug antibodies may neutralize therapeutic function, influence pharmacokinetics and, in some cases, lead to severe adverse effects. These effects depend on factors including dose, regimen, delivery route and contaminants, among others. Importantly, immunogenicity is a consideration that is better addressed during preclinical development before complications arise in clinical trials or following licensure. This article will address the development and application of computational tools for immunogenicity assessment of protein therapeutics, and validation of those predictions using peripheral blood from exposed subjects or alternative in vivo methods.
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“Despite these challenges, there are efforts aimed at predicting immunogenicity using in silico and in vitro tools.49”
From Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development (2018) · cites this paper as [49]
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Metadata
- Authors
- DEGROOT, A., MCMURRY, J., & MOISE, L.
- Affiliations
- University of Rhode Island (US)
- Corresponding author
- DEGROOT, A
- MOISE, L
- ORCID
- Venue
- Current Opinion in Pharmacology
- Publisher
- Elsevier BV
- Published
- 2008-10
- Volume
- 8
- Issue
- 5
- Pages
- 620-626
- ISSN
- 1471-4892 (ISSN-L)
- OpenAlex
- W2092720388
- Cited by
- 109
- References
- 55
- Citations by year
- 2026: 4 · 2024: 3 · 2023: 2 · 2022: 5 · 2021: 7 · 2020: 8 · 2019: 5 · 2018: 10 · 2017: 5 · 2016: 2 · 2015: 5 · 2014: 4 · 2013: 6 · 2012: 14
- FWCI
- 3.84
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Current Opinion in Pharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › vaccines and immunoinformatics approaches
- Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
- Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
- Keywords
- immunogenicity prediction, therapeutic proteins, antidrug antibodies, in silico prediction tools, preclinical drug development, pharmacokinetics, adverse drug reactions, neutralizing antibodies
- MeSH terms
- Animals, Epitopes, B-Lymphocytes, Computer Simulation, Drug Evaluation, Preclinical, Humans, Mice, Transgenic, Recombinant Proteins, T-Lymphocytes, Mice
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