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July 2006 Symposium on Nanotechnology and the Environment: Preclinical Characterization of Nanomaterials: Highlights, Question and Answer Session

July 12, 2:00-3:00 pm

Preclinical Characterization of Nanomaterials

Dr. Anil K. Patri, Nanotechnology Characterization Laboratory, National Cancer Institute at Frederick (SAIC Frederick), Frederick, Maryland


The Nanotechnology Characterization Laboratory (NCL) is established by the National Cancer Institute (NCI) to serve as a national resource and knowledge base for cancer researchers by performing and standardizing the pre-clinical characterization of nanomaterials intended for cancer therapeutics and diagnostics. The activities of NCL represent a formal scientific interaction of three Federal agencies: NCI, US Food and Drug Administration (FDA) and National Institute of Standards and Technology (NIST). Through these collaborations, the NCL will develop data that will facilitate standards for nanotechnology strategies and lay a scientific foundation that will enable informed regulatory decisions concerning the testing and approval of nanoscale cancer diagnostics, imaging agents, and therapeutics.

There are several advantages of multifunctional nanomaterial. They can be used as vehicles for carrying targeting agents, therapeutics and imaging agents. Through targeted delivery, the efficacy of the drug at the disease site is increased, even at lower doses, while minimizing toxic side-effects. Nanomaterial imaging agents can enhance the disease detection capability.

Small molecule therapeutic physicochemical characterization methods have been well established to facilitate regulatory review. For nanomaterial, new parameters such as size, polydispersities, shape, surface characteristics, composition, purity, stability etc. need to be measured as these parameters influence their in vivo biological behavior such as Adsorption, Distribution, Metabolism, and Excretion (ADME) and toxicity. NCL characterization cascade captures the structure-activity relationship trends and includes physico-chemical, in vitro and in vivo assays. NCL conducts these tests to help cancer researchers in academia, government and industry and in the process of developing standards at the American Society for Testing and Materials (ASTM) E56 committee on nanotechnology.

Question-and-Answer Session

A question was asked regarding the practicality of developing reference materials and running them through the techniques mentioned during Mr. Scalera’s presentation. Dr. Patri responded that reference materials are in the process of being developed by the National Institute of Standards and Technology (NIST). NIST will begin by fully characterizing two different sizes of nanomaterials. A NIST representative added that NIST is working with the National Cancer Institute to create standard materials and is considering using them in international discussions. NIST is starting with size-based standards and working toward other parameters.

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