National Institute of Standards and Technology (NIST)
Nanotechnology Characterization Laboratory (NCL)
Development and Validation of Clinical Proteomics Reference Standards
Nanotechnology Characterization Laboratory (NCL)
Established: 2004
The Nanotechnology Characterization Laboratory (NCL) performs and standardizes the pre-clinical characterization of nanomaterials intended for cancer therapeutics and diagnostics developed by researchers from academia, government, and industry. The NCL serves as a national resource and knowledge base for cancer researchers, and facilitates the development and translation of nanoscale particles and devices for clinical applications.
Under the auspices of the NCL, NIST will work closely with NCI and FDA to develop quantitative, reproducible measurement methods and protocols for nanoparticle characterization. NIST will bring the physical characterization to the partnerships. NIST will actively engage in program planning and execution for the NCL and all associated workshops and meetings. Finally, NIST scientists will vigorously collaborate with NCI and FDA researchers to determine the best measurement tools, protocols, and analysis algorithms for physically characterizing nanoparticles.
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 achieving its goals the NCL will provide a comprehensive set of baseline characterization parameters that will enable cancer biologists, drug and diagnostic developers, and clinical oncologists to apply their 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.
To achieve its mission, the NCL has established the following six objectives:
- Establish and standardize an analytical cascade for nanomaterial characterization
- Facilitate the clinical development and regulatory review of nanomaterials for cancer clinical trials
- Identify and characterize critical parameters related to nanomaterials’ absorption, distribution, metabolism, excretion and toxicity profiles of nanomaterials using animal models
- Examine the biological and functional characteristics of multi-component/combinatorial aspects of nanoscaled therapeutic, molecular and clinical diagnostics, and detection platforms
- Engage and facilitate academic and industrial-based knowledge sharing of nanomaterial performance data and behavior resulting from pre-clinical testing
- Interface with other nanotechnology efforts
For more information about the Nanotechnology Characterization Laboratory, please visit http://ncl.cancer.gov.
For more information about NCI’s funding of nanotechnology, click here.
Development and Validation of Clinical Proteomics Reference Standards
Established: 2006
NCI has partnered with the National Institute of Standards and Technology (NIST) to create and validate a 20-protein mixture to be used as a reference for proteomic analyses. This reference standard will support the Clinical Proteomic Technologies Initiative (CPTI) goal of developing common reagents and research tools for clinical proteomics.
These proteins were carefully selected with the interests of the clinical proteomics community in mind. For example, proteins in this reference mixture span the dynamic range of the plasma proteome and have commercially-available antibodies for validation experiments. Furthermore, many of the proteins have been associated with cancer processes. Each protein will be characterized for multiple properties, with the intent that the mixture will serve as a validated, reproducible resource to support cancer proteomics experiments.
In FY 2007, the Clinical Proteomic Technology Assessment for Cancer (CPTACs) will utilize these materials to conduct well-controlled “round robin” trials that feature MS and affinity-capture methodologies. Outcomes from these trials will inform the development of standard operating procedures (SOPs) for the clinical proteomics community.
To learn more about NIST visit www.NIST.gov.
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