ASTM Int'l Incorporates NCL Nanotech Standards to Aid Cancer Research

May 6, 2008 // Published as a news service by IHS

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The standards, which evaluate aspects of nanomaterial biocompatibility and toxicity, are:

• ASTM E 2524 - Test Method for Analysis of Hemolytic Properties of Nanoparticles is a protocol for examining the destruction of red blood cells ( hemolysis) that can lead to anemia, jaundice and other issues. All intravenously administered drugs must be examined to determine potential for hemolysis, said ASTM International.

• ASTM E 2525 - Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies describes a method for evaluating nanoparticle stimulation or inhibition of the maturation of certain bone marrow cells (macrophages). A common side effect of anti-cancer drugs is inhibition of this process and bone marrow cells may be particularly sensitive to nanoscale material.

• ASTM E2526 - Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials on Porcine Kidney Cells and Human Hepatocarcinoma Cells - because studies indicated that many nanoparticles are cleared from the body through the kidney or liver, these organs are good choices for target organ toxicity evaluation. ASTM E2526 presents a method for evaluation of nanomaterial toxicity by examining effects on kidney and cancerous liver cells.

The standards are under the jurisdiction of Subcommittee E56.02 on Characterization: Physical, Chemical and Toxicological Properties.

Martin Fritts, senior principal scientist at the Nanotechnology Characterization Laboratory and co-chair of ASTM Subcommittee E56.02, said the standards will be used by nanotech drug developers, scientists in the pharmaceutical, cancer research and nanotechnology fields, regulatory agencies and agencies evaluating the environmental health and safety risks associated with nanoparticles.

"We expect that standardization will accelerate the translation of nanotech therapeutics from the proof-of-concept discovery phase into clinical trials and eventually into commercially available drugs and benefits to patients," said Fritts, who also said that developers and manufacturers used ASTM standards in the medical and pharmaceutical fields but that the unique properties of nanomaterials frequently limit the applicability of traditional pharmaceutical methods.

Fritts said that Subcommittee E56.02 is planning on the development of other proposed standards as well as revisions that will incorporate precision and bias statements into the recently approved standards.

To accomplish this, ASTM E 2524, ASTM E 2525 and ASTM E 2526 are being used in an ASTM-sponsored interlaboratory study involving more than 60 labs.

The subcommittee is seeking assistance with data analysis for the study as well as participants for future studies. "Such interlaboratory comparison and standards for nanoparticle characterization will help alleviate confusion, dispel ambiguity, facilitate the regulatory process and accelerate the translation of nanotech drugs from bench to bedside," said Fritts.

Fritts also said that among the variety of nanoparticles used in the interlaboratory study will be nanoscale reference materials developed by the National Institute of Standards and Technology (NIST) specifically for the biomedical research community.

These new reference materials, which were produced with support from the NCI Alliance for Nanotechnology in Cancer and the NCL, consist of colloidal gold nanoparticles with nominal diameters of 10, 30 and 60 nanometers in suspension.

The new reference materials are intended for instrument calibration, method qualification and in vitro experiments used to characterize nanomaterials.

Source: ASTM International.