Journal
CANCER IMMUNOLOGY IMMUNOTHERAPY
Volume 65, Issue 11, Pages 1289-1301Publisher
SPRINGER
DOI: 10.1007/s00262-016-1875-9
Keywords
Beta-glucan; Lentinan; Biotherapeutics; Antibodies; Cancer; Immunostimulation
Categories
Funding
- Cancer Research UK (CRUK) [C30122/A11527, C30122/A15774]
- Academy of Medical Sciences
- Medical Research Council [MR/L023091/1]
- CRUK/National Institute for Health Research (NIHR) in England/Department of Health for Scotland, Wales
- Northern Ireland Experimental Cancer Medicine Centre [C10355/A15587]
- NIHR Biomedical Research Centre based at Guy's and St Thomas' National Health Service Foundation Trust and King's College London
- MRC [MR/L023091/1] Funding Source: UKRI
- Academy of Medical Sciences (AMS) [AMS-SGCL10-Josephs] Funding Source: researchfish
- Cancer Research UK [15774, 11060] Funding Source: researchfish
- Cancer Research UK
- Versus Arthritis [18887] Funding Source: researchfish
- Medical Research Council [MR/L023091/1] Funding Source: researchfish
- National Institute for Health Research [CL-2012-17-005] Funding Source: researchfish
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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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