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Detection of Endotoxin in Nano-formulations Using Limulus Amoebocyte Lysate (LAL) Assays

  1. Author:
    Neun,Barry
    Dobrovolskaia,Marina

  2. Author Address

    Frederick Natl Lab Canc Res, Nanotechnol Characterizat Lab, Canc Res Technol Program, Frederick, MD 21701 USA.
    1. Year: 2019
    2. Date: Jan 30
    3. Epub Date: 2019 01 30
  2. Journal: Journal of visualized experiments : JoVE
  3. JOURNAL OF VISUALIZED EXPERIMENTS,
    1. 143
  5. Type of Article: Article
  6. Article Number: e58830
  7. ISSN: 1940-087X
  1. Abstract:

    When present in pharmaceutical products, a Gram-negative bacterial cell wall component endotoxin (often also called lipopolysaccharide) can cause inflammation, fever, hypo- or hypertension, and, in extreme cases, can lead to tissue and organ damage that may become fatal. The amounts of endotoxin in pharmaceutical products, therefore, are strictly regulated. Among the methods available for endotoxin detection and quantification, the Limulus Amoebocyte Lysate (LAL) assay is commonly used worldwide. While any pharmaceutical product can interfere with the LAL assay, nano-formulations represent a particular challenge due to their complexity. The purpose of this paper is to provide a practical guide to researchers inexperienced in estimating endotoxins in engineered nanomaterials and nanoparticle-formulated drugs. Herein, practical recommendations for performing three LAL formats including turbidity, chromogenic and gel-clot assays are discussed. These assays can be used to determine endotoxin contamination in nanotechnology-based drug products, vaccines, and adjuvants.

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External Sources

  1. View Full Text
  2. DOI: 10.3791/58830
  3. PMID: 30774143
  4. View record in Web of Science®
  5. WOS: 000458012000148

Library Notes

  1. Fiscal Year: FY2018-2019
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