Evidence map›Paper›PMID 27473075›Full record

ReviewCancer immunology, immunotherapy : CII2016

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

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

Open access · hybridAbstract readReview
In one paragraph

Review in Cancer immunology, immunotherapy : CII, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.1field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 54 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Metabolism and Biodegradation of β-GlucanFrontiers in veterinary science · 2022
    Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. IgE Antibodies against Cancer: Efficacy and Safety.Antibodies (Basel, Switzerland) · 2020
    Review
  14. Review
  15. Article
  16. Article
  17. Nutrients · 2018
    Article
  18. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Claire BartonCancer Research UK Centre for Drug Development, Cancer Research UK, Angel Building, 407 St John Street, London, EC1V 4AD, UK. claire.barton@cancer.org.uk.ORCID 0000-0002-6407-1479
Kim VigorBiotherapeutics Development Unit, Cancer Research UK, South Mimms, Hertfordshire, EN6 3LD, UK.
Robert ScottBiotherapeutics Development Unit, Cancer Research UK, South Mimms, Hertfordshire, EN6 3LD, UK.
Paul JonesCancer Research UK Centre for Drug Development, Cancer Research UK, Angel Building, 407 St John Street, London, EC1V 4AD, UK.
Heike LentferBiotherapeutics Development Unit, Cancer Research UK, South Mimms, Hertfordshire, EN6 3LD, UK.
Heather J BaxDivision of Genetics and Molecular Medicine, Faculty of Life Sciences and Medicine, St. John's Institute of Dermatology, King's College London, 9th Floor, Guy's Tower Wing, Guy's Hospital, London, SE1 9RT, UK.
Debra H JosephsDivision of Genetics and Molecular Medicine, Faculty of Life Sciences and Medicine, St. John's Institute of Dermatology, King's College London, 9th Floor, Guy's Tower Wing, Guy's Hospital, London, SE1 9RT, UK.
Sophia N KaragiannisDivision of Genetics and Molecular Medicine, Faculty of Life Sciences and Medicine, St. John's Institute of Dermatology, King's College London, 9th Floor, Guy's Tower Wing, Guy's Hospital, London, SE1 9RT, UK.
James F SpicerDivision of Cancer Studies, Department of Research Oncology, Faculty of Life Sciences and Medicine, King's College London, 3rd Floor Bermondsey Wing, Guy's Hospital, Great Maze Pond, London, SE1 9RT, UK.
Cancer Research UK · GBGuy's Hospital · GB

Funding

Cancer Research UK 11060Cancer Research UK 15774Cancer Research UK 18887Cancer Research UK C30122/A11527Cancer Research UK C30122/A15774Medical Research Council MR/L023091/1
6 · The paper itself

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.

Indexed as

Risk AssessmentAnimalsbeta-GlucansBiosimilar PharmaceuticalsClinical Trials as TopicHumansImmunomodulationNeoplasmsPharmaceutical PreparationsTechnology, Pharmaceuticalbeta-GlucansBiosimilar PharmaceuticalsPharmaceutical PreparationsAntibodiesBeta-glucanBiotherapeuticsCancerImmunostimulationLentinan

Identifiers

PMID27473075
PMCPMC5069311
OpenAlexW2494994180

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.