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Nanomedicine (Lond). 2014;9(12):1847-56. doi: 10.2217/nnm.13.157. Epub 2013 Dec 20.

Choice of method for endotoxin detection depends on nanoformulation.

Author information

1
Nanotechnology Characterization Laboratory, Leidos Biomedical Research Inc., Frederick National Laboratory for Cancer Research, 1050 Boyles Street, Frederick, MD 21702, USA. marina@mail.nih.gov.

Abstract

AIMS:

Many nanoparticles interfere with traditional tests to quantify endotoxin. The aim of this study was to compare the performance of limulus amoebocyte lysate (LAL) formats on clinical-grade nanoformulations, to determine whether there were disparate results among formats and to test the applicability of an alternative bioassay (the macrophage activation test [MAT]) for resolving discrepancies, if observed.

MATERIALS & METHODS:

Clinical-grade nanoformulations were tested using turbidimetric, gel-clot and chromogenic LAL. Formulations that cause a discrepancy among LAL tests were also tested by the MAT.

RESULTS & CONCLUSION:

The gel-clot LAL method cannot be relied upon to resolve discrepancies among LAL tests for certain nanoformulations. No one LAL format was shown to be optimal for all the tested clinical-grade nanoformulations. The tested alternative bioassay (the MAT) was useful for verifying LAL findings, but only for those nanoformulations not carrying/including cytotoxic drugs.

KEYWORDS:

endotoxin; in vitro assay; interference; limulus amoebocyte lysate; lipopolysaccharide nanoparticles; rabbit pyrogen test

PMID:
24359551
DOI:
10.2217/nnm.13.157
[Indexed for MEDLINE]

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