NIST Organizers: Lili Wang, John Elliott, Sheng Lin-Gibson
FDA Organizers: Steven Bauer, Heba Degheidy, Judy Arcidiacono
NIST and FDA are actively collaborating on projects that address regulatory and measurement challenges for cell therapies and regenerative medicine products. These collaborations leverage NIST expertise in measurement sciences to address specific analytical challenges as well as FDA regulatory science, research and review expertise in these advanced application areas to ensure that the science and standards developed address significant regulatory challenges that recur across the field. Building on the success of the previous NIST-FDA Cell Counting Workshop, NIST and FDA plan to host a Workshop to examine measurement challenges associated with flow cytometry.
Flow cytometry is a powerful tool for cell characterization and function analysis. Despite wide use of flow cytometry, the challenges associated with robust cellular measurands, the lack of adequate biological and non-biological reference materials, and the complexity of the instrumentation have resulted in few standards to address measurement assurance. This workshop will identify application challenges in clinical and cell manufacturing settings, and potential solutions for overcoming gaps in obtaining sufficient measurement assurance for flow cytometry. The expected outcome of the workshop is a Whitepaper to be published in a peer reviewed journal as well as input into standards and best practices for quantitative, comparable flow cytometry.
More details to come.
- FDA Organizers: Steven Bauer, Heba Degheidy, Judy Arcidiacono
- U.S. Food and Drug Administration10903 New Hampshire AvenueSilver Spring, MD 20993