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Technical Services for Select NCL Assays

Select Nanotechnology Characterization Laboratory (NCL) assays are available to nanotech developers as Technical Services. Technical Services differ from contractor Cooperative Research and Development Agreement (cCRADA) collaborations in that these are not research and development collaborations. The Technical Services have a pre-defined statement of work, depending on the service selected and cannot be modified. The assays are chosen based on demand from the field and limited or lack of availability from other organizations or contract research organizations. They have been used to test a variety of nanoformulations and the conditions are well established, thus requiring little to no development and optimization.

Available Services

The NCL currently has two Technical Services available, both based on the Stable Isotope Tracer Ultrafiltration Assay (SITUA)—an analytical method invented at NCL that can measure key nanomedicine fractions in plasma.

NCL-01: An in vitro drug release study in human plasma using the SITUA. The assay will provide concentrations of encapsulated, free/unbound, and protein-bound drug and is ideal for formulation optimization and lot release.

NCL-02: A pharmacokinetic study in rats using the SITUA. Blood samples will be collected at various timepoints for analysis of encapsulated, free/unbound, and protein-bound drug concentrations, as well as noncompartmental pharmacokinetic analysis to complement preclinical bioequivalence evaluation.

Hear Dr. Stephan Stern talk about the SITUA with Dr. Vladimir Popov, Director of the Frederick National Lab's Partnership Development Office. 

Purchasing a Technical Service

Interested parties are encouraged to first contact the NCL. A preliminary discussion will help NCL gain an understanding of your technology, nanoformulation properties, and how the selected service is expected to aid your developmental path. In addition, we’ll be able to address any questions you have about the assay, sample requirements, or time lines.

After this initial discussion, the NCL will put you in contact with the Partnership Development Office for the Frederick National Lab. They will guide you through the necessary steps for purchasing the Technical Service, including execution of the Technical Services Agreement contract. Once the agreement is executed, payment must be made in full prior to shipping samples.

Questions

For scientific questions related to the assays, please contact the NCL. We’re happy to discuss the feasibility of the study and sample requirements prior to initiation of the contract.

Email: ncl@mail.nih.gov

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