The Nanotechnology Characterization Laboratory (NCL) accelerates the development of nanotechnology for basic and applied cancer
research. Working in collaboration with FDA and the National Institute of Standards and Technology, NCL standardizes the preclinical
characterization of nanomaterials that academic, government, and industry researchers are developing as cancer therapeutics and
diagnostics. NCL has evaluated more than 200 nanoparticle formulations, many of which have gone forward into clinical testing.
The lab offers preclinical characterization services, via an application
process, to investigators from any organization who have developed promising nanotechnology-based cancer treatments.
Once accepted, all characterization is performed at no charge to the submitting investigator. The characterization
services offered are intended to support IND or IDE applications with the US FDA.
The NCL utilizes a three tiered Assay Cascade to thoroughly characterize each nanomaterial strategy submitted
the lab. Physicochemical characterization includes aspects such as size distribution, drug concentration, stability,
purity, and surface characteristics. In vitro testing involves assessment of sterility and endotoxin, blood compatibility,
immune cell functions, oxidative stress, cytotoxicity, and autophagic dysfunction. The NCL also collaborates with
the FNLCR’s Laboratory Animal Science Program and the Small Animal Imaging Program to provide in vivo assessment
of toxicity, efficacy, immunotoxicity, and pharmacokinetics.
Though preclinical characterization is the Nanotechnology Characterization Laboratory’s (NCL) main area of expertise,
we’re excited about nanotech’s possibilities for improving cancer drugs and patient quality of life. NCL has recently
begun doing some in-house formulation work under Contractor Cooperative Research and Development Agreements (cCRADAs).
In these partnerships, the cCRADA partner (usually a pharmaceutical company) discloses the drug structure and
characteristics to be optimized under confidentiality/nondisclosure agreement and NCL recommends a reformulation
strategy. Once a strategy is agreed upon, the drug is supplied to NCL for nanoparticle-based formulation and testing.
When the novel reformulation meets an agreed-upon threshold for improvement, the improved formulation is transferred
back to the pharmaceutical company for further evaluation, clinical and commercial development. The pharmaceutical
company partner contributes financial support for the reformulation and testing conducted at NCL through a cCRADA.
These sorts of collaborations allow NCL to use the knowledgebase we’ve amassed from 7 years of testing nanotech
drug products to help companies make failed drugs viable or make already-good drugs better. We have expertise
in formulation and characterization of an extensive variety of nanotechnology-based platforms, including polymeric,
lipid-based, dendrimer and inorganic.
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