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Evaluation of nanoparticle immunotoxicity

Nature Nanotechnology volume 4, pages 411–414 (2009)Cite this article

Abstract

The pharmaceutical industry is developing increasing numbers of drugs and diagnostics based on nanoparticles, and evaluating the immune response to these diverse formulations has become a challenge for scientists and regulatory agencies alike. An international panel of scientists and representatives from various agencies and companies reviewed the imitations of current tests at a workshop held at the National Cancer Institute in Frederick, Maryland. This article outlines practical strategies for identifying and controlling interferences in common evaluation methods and the implications for regulation.

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Figure 1: Nanoparticles interfere with traditional LAL assays.
Figure 2: Decision tree for selecting the appropriate endotoxin test, and approaches for overcoming nanoparticle interference.
Figure 3: Selecting tests for studying the compatibility of nanoparticles with blood.

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Author information

Authors and Affiliations

  1. Nanotechnology Characterization Laboratory, SAIC-Frederick Inc., NCI-Frederick, Frederick, 21702, Maryland, USA

    Marina A. Dobrovolskaia

  2. Toxicology Branch, National Toxicology Program, National Institute of Environmental Health Sciences, NIH, DHHS, Research Triangle Park, 27709, North Carolina, USA

    Dori R. Germolec

  3. Division of Applied Pharmacology Research, CDER, US FDA, Silver Spring, 20993, Maryland, USA

    James L. Weaver

Authors
  1. Marina A. Dobrovolskaia
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  2. Dori R. Germolec
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  3. James L. Weaver
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Corresponding author

Correspondence to Marina A. Dobrovolskaia.

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Dobrovolskaia, M., Germolec, D. & Weaver, J. Evaluation of nanoparticle immunotoxicity. Nature Nanotech 4, 411–414 (2009). https://doi.org/10.1038/nnano.2009.175

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