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Frederick National Laboratory and Immune Analytics strengthen their regulated immunomonitoring capabilities

The Nanotechnology Characterization Laboratory (NCL) at the Frederick National Laboratory for Cancer Research (FNL) and the AID group‘s CRO, Immune Analytics have formed the FluoroSpot validation project partnership to enable the harmonized immunomonitoring of preclinical and clinical samples according to international regulatory standards.

The project will demonstrate the eligibility of a two-color FluoroSpot assay for the quantification of specific T cells (secreting IFN-γ and IL-2) for a given validated model antigen. Both laboratories will first validate the FluoroSpot assay using identical human blood samples and target for identical assay acceptance criteria. The laboratories will then be able to perform robust and validated preclinical and clinical sample analytics, a requirement of regulatory bodies to accept exchangeable data sets generated in different laboratories during formal drug/vaccine development projects. A risk-based partial FluoroSpot validation will allow the performance of different bioanalytical projects in the future, such as the immunomonitoring of a wide range of novel cancer vaccines.

The NCL serves the US and international nanotechnology research community to advance the science of nanoparticle characterization and accelerate the progress of nanomedicines from bench to clinic by providing preclinical characterization and safety testing of nanoparticles. The NCL is a collaborative effort between the National Cancer Institute (NCI), the US Food and Drug Administration (FDA), and the National Institute of Standards and Technology (NIST). The NCL serves as a resource and knowledge base for all cancer researchers in academia, industry, and government to facilitate the development and clinical translation of nanotechnologies intended as cancer therapeutics and diagnostics.

The FNL is a Federally Funded Research and Development Center dedicated to the application of biomedical science and technology to improve human health by conducting basic, translational, and applied research, creating new technologies, and collaborating with government, industry, and academic colleagues. The FNL supports the NCI and other institutes of the National Institutes of Health. As a government-owned, contractor-operated scientific enterprise, FNL efficiently addresses critical biomedical questions and rapidly responds to emerging health threats.

Founded in 1989 with headquarters in the south-west of Germany, AID produces and markets diagnostic products, imaging devices, and suitable software programs within a wide range of immunology and infectious diseases. AID is the developer and manufacturer of one of the most frequently used EliSpot readers worldwide, the AID EliSpot Reader System. In 2017, the AID group established Immune Analytics, a CRO unit that focuses on customized development and validation of EliSpot/FluoroSpot assays for GLP and GCLP-compliant immunomonitoring of preclinical and clinical samples to quantify specific T and B cell responses.



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