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Detection of Beta-Glucan Contamination in Nanotechnology-Based Formulations

  1. Author:
    Neun,Barry
    Cedrone,Edward
    Potter, Timothy M.
    Crist,Rachael
    Dobrovolskaia,Marina

  2. Author Address

    Frederick Natl Lab Canc Res, Nanotechnol Characterizat Lab, Canc Res Technol Program, Frederick, MD 21702 USA.
    1. Year: 2020
    2. Date: AUG
    3. Epub Date: 2020 07 24
  2. Journal: Molecules (Basel, Switzerland)
  3. MDPI,
    1. 25
    2. 15
  5. Type of Article: Review
  6. Article Number: ARTN 3367
  7. ISSN: 1420-3049
  1. Abstract:

    Understanding the potential contamination of pharmaceutical products with innate immunity modulating impurities (IIMIs) is essential for establishing their safety profiles. IIMIs are a large family of molecules with diverse compositions and structures that contribute to the immune-mediated adverse effects (IMAE) of drug products. Pyrogenicity (the ability to induce fever) and activation of innate immune responses underlying both acute toxicities (e.g., anaphylactoid reactions or pseudoallergy, cytokine storm) and long-term effects (e.g., immunogenicity) are among the IMAE commonly related to IIMI contamination. Endotoxins of gram-negative bacteria are the best-studied IIMIs in that both methodologies for and pitfalls in their detection and quantification are well established. Additionally, regulatory guidance documents and research papers from laboratories worldwide are available on endotoxins. However, less information is currently known about other IIMIs. Herein, we focus on one such IIMI, namely, beta-glucans, and review literature and discuss the experience of the Nanotechnology Characterization Lab (NCL) with the detection of beta-glucans in nanotechnology-based drug products.

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External Sources

  1. View Full Text
  2. DOI: 10.3390/molecules25153367
  3. PMID: 32722261
  4. View record in Web of Science®
  5. WOS: 000559080000001

Library Notes

  1. Fiscal Year: FY2019-2020
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