Assay Cascade Characterization Program
The Nanotechnology Characterization Laboratory (NCL) performs preclinical characterization of nanoparticles to facilitate the regulatory review of nanotechnology concepts intended as cancer therapies and diagnostics. This resource is available to researchers in academia, industry, and government to enable further development of their nanotechnology strategies towards clinical applications. The critical infrastructure and characterization services afforded through this program are provided to nanomaterial researchers at no cost and are available through an application process.
The Assay Cascade
As part of its Assay Cascade, the NCL will characterize a nanoparticles' physical and chemical attributes, their in vitro biological properties, and their in vivo compatibility using animal models using a standardized characterization cascade developed in collaboration with the US Food and Drug Administration (FDA) and National Institute of Standards and Technology (NIST). This in-depth characterization spans the areas of physicochemical characterization, in vitro and in vivo immunological characterization, and in vitro and in vivo pharmacology and toxicology.
The primary output of NCL's Assay Cascade will be data and information related to the nanoparticles' physical and chemical properties, as well as interaction and compatibility with biological systems. These data will be provided to the originating investigator in support of an investigational new drug application. Data can also be used to garner venture capital, for publications, or to seek additional research funding.
If a nanotechnology strategy is selected for characterization, NCL's services will be provided at no cost to the submitting investigator. The NCL team, in consultation with the applicant, will design a research plan individually tailored for each nanoformulation, considering the nanoparticle platform, drug, intended clinical indication, dose, and route of administration. The time required to characterize a nanomaterial from receipt through the in vivo phase is anticipated to be about one year.