Select NCL assays are made available to nanotech developers as Technical Services. Technical Services differ from 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/lack of availability from other organizations or Contract Research Organizations (CRO). They have been used to test a variety of nanoformulations and the conditions are well established, thus requiring little to no development and optimization.
The NCL currently has three Technical Services. Two services are available for evaluating nanomedicine drug release and pharmacokinetics (NCL-01 and NCL-02). A third service is available for identifying the risk of infusions reactions (NCL-05).
NCL-01: An in vitro drug release study in human plasma using the stable isotope tracer ultrafiltration assay (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.
Download a printable brochure with details and FAQs on the SITUA and the NCL-01 and NCL-02 Technical Services.
NCL-05: Three in vitro assays that, when analyzed together, can be indicative of infusion reactions. The three assays are: platelet aggregation, complement activation, and inflammatory cytokine expression. Each assay addresses one of the mechanisms currently known to trigger infusion reactions, and together, they offer a useful and comprehensive package that can help investigators understand the potential risk.
Download a printable brochure with details and FAQs on the NCL-05 Technical Service.
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, time lines, etc.
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. You will be asked to first sign the Technical Services Agreement contract. A template agreement is posted below. Once the agreement is executed, you will need to arrange for payment to made in full prior to shipping samples.
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 TSA contract.
For questions related to the Technical Service Agreement contract or payment requirements, please contact:
Partnership Development Office