Ready for Transfer

Nanotechnology Characterization Laboratory Unveils New Technical Services for Drug Developers

Dept. of Health and Human Services

Drug developers now have access to a shared analytical technology, developed and provided by the Frederick National Laboratory for Cancer Research, that helps fine-tune nanomedicine formulations and overcomes a key hurdle on the path toward Food and Drug Administration approval of effective new therapies and generic versions of nanomedicines. 

The technology—a stable isotope tracer ultrafiltration assay (SITUA), developed at the Nanotechnology Characterization Laboratory at the Frederick National Laboratory, can be used to measure active drug release from a nanomedicine upon systemic administration. Understanding this dynamic is essential for comparing the activity of a proposed generic drug with the original branded medicine. The dynamic must be the same for both the generic and original versions of the drug.

“The SITUA method is a substantial improvement in nanomedicine bioanalysis,” said Stephan Stern, Ph.D., senior principal scientist and head of pharmacology and toxicology at the Nanotechnology Characterization Laboratory. “Our hope is that the method will complement drug development efforts and facilitate regulatory review of complex generic and similar bioequivalence.”

These new services using SITUA support the Nanotechnology Characterization Laboratory’s mission to be a national resource for cancer researchers and organizations developing nano-based therapies and diagnostics. The nanotechnology laboratory has over 10 years of knowledge and expertise in nanoparticle characterization and has tested more than 350 nanomaterials. The laboratory also leverages its expertise in cancer nanomedicines to assist with non-oncology nanomedicines. To date, the laboratory has helped 14 companies with novel nanomedicine therapies that have gone through regulatory filing with the Food and Drug Administration.

Previously, the Nanotechnology Characterization Laboratory’s collaborations have all been through contractor Cooperative Research and Development Agreements (cCRADAs) or its free Assay Cascade Characterization Service. The new technical services will enable easier access for drug developers to some of the laboratory’s unique capabilities, specifically the SITUA method. These services also come with access to the expertise of the laboratory, which will be offering consultation and assistance with data interpretation as part of the service.

The new services are as follows:

  • Pharmacokinetic Study in Rats Utilizing the SITUA – A pharmacokinetic study in rats to complement a preclinical program.
  • Drug Release in Human Plasma Utilizing the SITUA – An in vitro drug release study in human plasma matrix for use in formulation optimization and lot release.

The pharmacokinetic study in rats will also involve the Frederick National Laboratory’s Laboratory Animal Sciences Program for the animal-study portion of the work.

More details on the SITUA can be found in the following publications:

Technical Services Program

The Frederick National Laboratory’s technical services are all made available to the research community via Technical Service Agreements (TSAs), which are modified cCRADAs with pre-established terms and pricing, enabling them to be negotiated and executed in as little as a week. The Technical Services Program now offers 21 unique services covering a wide-range of biomedical services and solutions. Visit the Frederick National Laboratory website for the complete list of available technical services.