Nanotechnology Characterization Laboratory (NCL)
NCI established the Nanotechnology Characterization Laboratory (NCL) to accelerate the progress of nanomedicine by providing preclinical characterization and safety testing of nanoparticles. It is a collaborative effort between NCI, the US Food and Drug Administration (FDA), and the National Institute of Standards and Technology (NIST).
The NCL serves as a resource and knowledge base for all cancer researchers in academia, industry, and government to facilitate the development and clinical translation of nanotechnologies intended as cancer therapeutics and diagnostics. NCL supports the characterization of:
- concepts with proven efficacy for cancer therapy, diagnosis, or vaccines
- novel, early-stage nanomedicine platforms with potential for cancer therapy
- concepts intended to alleviate side effects, toxicities and other complications cancer patients experience as a result of cancer therapy
Considering the relevance of nanoparticles to combat COVID-19 pandemic, the NCL also supports the characterization of nanotechnology-based COVID vaccines and therapeutics.
There are multiple ways the NCL can help nanotech researchers and developers advance their technology, including characterization, formulation, optimization, lead selection, and method development.
Assay Cascade Characterization Program
NCL has a free preclinical characterization service for developers of oncology-based nanoformulations to help in their development toward clinical trials.
cCRADA Collaborations: Tailored Solutions for Nano-related Research and Development
cCRADA collaborations provide tailored solutions for an investigator’s nanotechnology-related development needs. Typical projects include nanotech formulation, characterization of non-oncology nanomaterials, mechanistic studies, and method development.
Technical services are predefined statements of work for select NCL assays, with a fixed cost for each service. NCL provides two technical services, both based on the Stable Isotope Tracer Ultrafiltration Assay (SITUA) –an analytical method invented at NCL that measures key nanomedicine fractions in plasma.
Protocols and Capabilities
The NCL has developed a standardized analytical cascade that performs physicochemical characterization as well as preclinical testing of the immunology, pharmacology, and toxicology properties of nanomaterials. The data generated can be used in regulatory filings, in publications, and to garner interest from investors.
The NCL was founded in 2004 in collaboration with FDA and NIST, as a public–private partnership to advance the science needed to expedite the development of promising nanotech therapies and diagnostics. The NCL has tested more than 450 unique nanomaterials and worked with more than 125 investigators worldwide.