One challenge faced by cancer researchers who work with nanotechnology constructs - structures smaller than one-billionth of a meter in size - is how to effectively characterize these novel particles to obtain FDA permission to advance to human clinical trials. The Nanotechnology Characterization Laboratory (NCL), located at NCI-Frederick, was created to respond to this challenge. NCL is a part of a large initiative, the NCI Alliance for Nanotechnology in Cancer, which funds extramural research and training programs to improve prevention, diagnosis, and treatment of cancer using nanotechnology.
Funded by NCI under the Alliance program with collaboration from FDA and the National Institute of Standards and Technology, the NCL provides free preclinical testing and characterization of nanomaterials to partners in academia and small business. Since its inception, the laboratory has characterized more than 100 nanotechnology strategies with a rigorous assay cascade that includes physicochemical analysis, toxicology, pharmacology, and efficacy testing.
Results from this assay provide the information needed by the investigators to apply for an Investigational New Drug or Investigational Device Exemption application and, importantly, provides the NCL with data and experience to compile best practice guidelines to aid the process of characterizing nanomaterials for future clinical applications. "We find that the typical users of our protocols are small businesses attempting to do preclinical characterization," says Dr. Scott McNeil, director of the NCL.
The NCL assay cascade has already confronted challenges related to the inherent properties of nanomaterials. NCL investigators quickly learned that nanoparticles, many of which have catalytic or fluorescent properties, can interfere with traditional assays.
"Early on, we put some nanoparticles into an endotoxin assay, which is based on the cleavage of a protein to indicate bacterial contamination," explains Dr. McNeil. "The nanoparticles caused a robust response that was even more pronounced than if there had been bacteria present, because they were actually cleaving that protein."
Developing new controls to test for enhancement and inhibition of such standard assays has become an important part of NCL research. Location at the NCI-Frederick campus offers important advantages in this process, says Dr. McNeil. "For example, the Advanced Technology Program has half-a-dozen mass spectrometers, plus capillary electrophoresis, genomics and proteomics technology, and electron microscopy. So rather than NCL hiring those types of expertise as additional staff, we can simply walk downstairs and have access to those resources."