ReviewMolecules (Basel, Switzerland)2021
Innate Immunity Modulating Impurities and the Immunotoxicity of Nanobiotechnology-Based Drug Products.
Review in Molecules (Basel, Switzerland), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed.
- Impact of Modifying Abicipar Manufacturing Process in Patients with Neovascular Age-Related Macular Degeneration: MAPLE Study Results.Clinical ophthalmology (Auckland, N.Z.) · 2023Trial
- Are Silver and Gold Nanoparticles Obtained by 'Green' Synthesis Biocompatible?Nanomaterials (Basel, Switzerland) · 2026Review
- Host cell protein impurities in therapeutic proteins: overview of advances in detection, nonconventional removal technologies and immunogenicity assessment.Journal of biological engineering · 2026Review
- Charting new frontiers in nanoparticle immunotoxicity: A perspective on current, emerging, and future approaches.Biochemical and biophysical research communications · 2025Review
- Evaluating Biocompatibility: From Classical Techniques to State-of-the-Art Functional Proteomics.Nanomaterials (Basel, Switzerland) · 2025Review
- Nucleic acid nanobiosystems for cancer theranostics: an overview of emerging trends and challenges.Nanomedicine (London, England) · 2025Review
- Strategies to reduce the risks of mRNA drug and vaccine toxicity.Nature reviews. Drug discovery · 2024Review
- Detection of Beta-Glucan Contamination in Nanoparticle Formulations.Methods in molecular biology (Clifton, N.J.) · 2024Article
- Special Issue "Nanotechnology to Overcome the World's Most Critical Health Issues: Liposomes and Beyond-A Themed Issue Dedicated to Professor Yechezkel Barenholz".Molecules (Basel, Switzerland) · 2023Article
- Immunophenotyping: Analytical approaches and role in preclinical development of nanomedicines.Advanced drug delivery reviews · 2022Review
- Lessons learned from immunological characterization of nanomaterials at the Nanotechnology Characterization Laboratory.Frontiers in immunology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
Abstract
Innate immunity can be triggered by the presence of microbial antigens and other contaminants inadvertently introduced during the manufacture and purification of bionanopharmaceutical products. Activation of these innate immune responses, including cytokine secretion, complement, and immune cell activation, can result in unexpected and undesirable host immune responses. These innate modulators can also potentially stimulate the activation of adaptive immune responses, including the formation of anti-drug antibodies which can impact drug effectiveness. To prevent induction of these adverse responses, it is important to detect and quantify levels of these innate immunity modulating impurities (IIMIs) that may be present in drug products. However, while it is universally agreed that removal of IIMIs from drug products is crucial for patient safety and to prevent long-term immunogenicity, there is no single assay capable of directly detecting all potential IIMIs or indirectly quantifying downstream biomarkers. Additionally, there is a lack of agreement as to which of the many analytical assays currently employed should be standardized for general IIMI screening. Herein, we review the available literature to highlight cellular and molecular mechanisms underlying IIMI-mediated inflammation and its relevance to the safety and efficacy of pharmaceutical products. We further discuss methodologies used for direct and indirect IIMI identification and quantification.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.