Detection of Beta-Glucan Contamination in Nanoparticle Formulations.

Beta-glucans Contamination Immunomodulation Inflammation Nanoparticles Pathogen-associated molecular patterns Pattern recognition receptors

Journal

Methods in molecular biology (Clifton, N.J.)

ISSN: 1940-6029

Titre abrégé: Methods Mol Biol

Pays: United States

ID NLM: 9214969

Informations de publication

Date de publication:
2024

Historique:

medline: 20 3 2024

pubmed: 20 3 2024

entrez: 20 3 2024

Statut: ppublish

Résumé

Beta-glucans with diverse chemical structures are produced by a variety of microorganisms and are commonly found in microbial cell walls. β-(1,3)-D-glucans are present in yeast and fungi, and, for this reason, their traces are commonly used as a sign of yeast or fungal infection or contamination. Despite being less immunologically active than endotoxins, beta-glucans are pro-inflammatory and can activate cytokines and other immunological responses via their cognate pattern recognition receptors. Unlike endotoxins, there is no established threshold pyrogen dose for beta-glucans; as such, their quantity in pharmaceutical products is not regulated. Nevertheless, regulatory agencies recognize the potential contribution of beta-glucans to the immunogenicity of protein-containing drug products and recommend assessing beta-glucans to aid the interpretation of immunotoxicity studies and assess the risk of immunogenicity. The protocol for the detection and quantification of β-(1,3)-D-glucans in nanoparticle formulations is based on a modified limulus amoebocyte lysate assay. The results of this test are used to inform immunotoxicity studies of nanotechnology-based drug products.

Identifiants

DOI: 10.1007/978-1-0716-3786-9_10 PMID: 38506995

pubmed: 38506995

doi: 10.1007/978-1-0716-3786-9_10

doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

101-108

Informations de copyright

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