Nanotechnology Characterization Laboratory (NCL)

Nanoscale particles and devices are similar in size to biomolecules and can easily enter most cells. Our ability to manipulate the physical, chemical, and biological properties of these particles affords researchers the ability to engineer and use nanoparticles for drug delivery, as image contrast agents, and for diagnostic purposes.

NCI is establishing the Nanotechnology Characterization Laboratory (NCL) at its NCI-Frederick facility to provide critical infrastructure support to this rapidly developing field. Working in concert with the National Institute of Standards and Technology (NIST) and the U.S. Food and Drug Administration (FDA), the intent of the NCL is to accelerate the transition of basic nano-biotech research into clinical applications.

Specifically, the NCL's goals are to:

• Standardize the preclinical testing and characterization of nanoscale devices to speed the regulatory review of novel diagnostics, therapeutics, and prevention strategies that use nanoscale devices.
• Perform preclinical toxicology, pharmacology, and efficacy testing of nanoscale devices created both by NCI intramural and extramural efforts as well as by the private sector.
• Facilitate collaborations between the NCI, academia, and the private sector to accelerate the translation of basic nanotechnology research into clinical advances.
• Serve as a nexus for multidisciplinary research, development, and clinical applications of nanotechnology; provide resources, knowledge, tools, and methods for intramural and extramural cancer researchers.
• Collaborate with other government agencies to leverage resources and expertise in pursuit of common goals in the acceleration of the use of nanotechnology for critical national applications, and team with industry to bring those applications to market.

A key activity of the NCL will be to work together with NIST and FDA scientists to develop an assay cascade that can serve as the standard protocol for preclinical toxicology, pharmacology, and efficacy testing of nanoscale devices. This assay cascade will characterize a nanoscale device's physical attributes, its in vitro biological properties, and its in vivo compatibility.

In carrying out these functions, the NCL will provide a comprehensive set of baseline characterization parameters that will enable cancer biologists, drug and diagnostic developers, and clinical oncologists to concentrate on what they do best-applying these tools to solving problems that most affect cancer patients. This work will also lay a scientific foundation that will enable the FDA to make sound decisions concerning the testing and approval of nanoscale cancer diagnostics, imaging agents, and therapeutics.

From its discussions with experts in academia and the private sector, the NCI believes that the NCL's activities will markedly speed the development of nanotechnology-based products for cancer patients, reduce the risk of doing so, and encourage private-sector investment in this promising area of technology development. By taking on this role, the NCL will greatly accelerate the development of the paradigm-changing advances needed to meet the goal of eliminating suffering and death from cancer by 2015.