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Cancer Immunology, Immunotherapy
Published in: Cancer Immunology, Immunotherapy 11/2016

Open Access 01-11-2016 | Review

Beta-glucan contamination of pharmaceutical products: How much should we accept?

Authors: Claire Barton, Kim Vigor, Robert Scott, Paul Jones, Heike Lentfer, Heather J. Bax, Debra H. Josephs, Sophia N. Karagiannis, James F. Spicer

Published in: Cancer Immunology, Immunotherapy | Issue 11/2016

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Abstract

Beta-glucans are large polysaccharides produced by a range of prokaryotic and eukaryotic organisms. They have potential immunostimulatory properties and have been used with therapeutic intent as anti-microbial and anti-tumour agents. A range of other potentially beneficial effects have been described, and oral forms of beta-glucans are widely available over-the-counter and online. Parenteral formulations are popular in parts of Asia and are the subject of ongoing trials, worldwide. Beta-glucans are also potential contaminants of pharmaceutical products, and high levels have been described in some blood products. However, little is known about the clinical effects of such contamination, considerable uncertainty exists over the level at which immunostimulation may occur, and there are no guidelines available on acceptable levels. We encountered beta-glucan contamination of one of our products, and we suspect that others may encounter similar issues since the origin of beta-glucan contamination includes commonly used filters and solutions applied in the manufacture of biotherapeutic agents. It is likely that regulators will increasingly enquire about beta-glucan levels in pharmaceutical products, especially those with an immunomodulatory mechanism of action. Here, we review the literature on beta-glucans in pharmaceutical products and propose an acceptable level for therapeutic agents for parenteral use.
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Metadata
Title
Beta-glucan contamination of pharmaceutical products: How much should we accept?
Authors
Claire Barton
Kim Vigor
Robert Scott
Paul Jones
Heike Lentfer
Heather J. Bax
Debra H. Josephs
Sophia N. Karagiannis
James F. Spicer
Publication date
01-11-2016
Publisher
Springer Berlin Heidelberg
Published in
Cancer Immunology, Immunotherapy / Issue 11/2016
Print ISSN: 0340-7004
Electronic ISSN: 1432-0851
DOI
https://doi.org/10.1007/s00262-016-1875-9

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