Flow cytometry is used to analyze individual cells to understand the proteins, nucleic acids and other biomolecules they have or produce, and to analyze groups of cells to differentiate among different cell types and lineages. Flow cytometry is widely used by manufacturers of biopharmaceuticals to produce therapies that are made by living cells, or composed of living cells. We launched the NIST Flow Cytometry Standards Consortium to accelerate the adoption of quantitative flow cytometry in biomanufacturing of cell and gene therapies. The Consortium will develop standards for flow cytometry applications and reference materials for instrument calibrations.
Access to a neutral forum to address pre-competitive needs
Participation in the development of reference materials, methods and protocols, and interlaboratory studies
Access to tools developed by the Consortium ahead of public release
Institutional representation on Consortium steering committee
BECOME A MEMBER
Complete the Letter of Interest Form
Participants will sign a Cooperative Research and Development Agreement (CRADA); Federal agencies may join under a Letter Agreement (LA)
Annual fee of $25,000 or in-kind support of equivalent value
Notice of NIST's Flow Cytometry Standards Consortium
Advances in cell and gene-based therapeutics as well as other regenerative medicine products have increased the need for high quality, robust, and validated measurements for cell characterization. Flow cytometry, including imaging cytometry, has emerged as an important platform due to its ability to rapidly and simultaneously characterize heterogeneous cell populations and subcellular analytes. For example, flow cytometry has been critical for establishing identity, purity, and potency for Chimeric Antigen Receptor (CAR)-T cell manufacturing; and associated data to support the approval of Biological License Applications (BLA) by the U.S. Food and Drug Administration (FDA) and the approval by the European Medicines Agency (EMA). In addition, multiparameter flow cytometric measurements are routinely carried out in vaccine, drug and cancer research, clinical diagnosis, and immunotherapies. However, challenges remain with respect to measurement confidence and comparability of measurement results from different instrument platforms, locations, and over time, hindering critical decision-making based on flow cytometry data in research and clinical settings. The NIST Flow Cytometry Standards Consortium aims to bring together experts across the regenerative medicine field including stakeholders in industry, academia and government to address this need.
Develop reference standards including reference materials, reference data, reference methods, and measurement service for assigning the Equivalent Number of Reference Fluorophores (ERF) to calibration microspheres and assessing the associated uncertainties and utilities.
Develop candidate reference standards including biological reference materials, reference data, reference methods
Design interlaboratory studies based on candidate reference materials to support the development of best practices and standard methods
In coordination with the Consortium steering committee, Working Groups will be established to meet the Consortium goals
Shared measurement assurance tools and standards for flow cytometry measurement confidence
Data from interlaboratory studies to support development of best practices and standard methods
Improved flow cytometry measurement capabilities
Convenes industry, academia, and government to identify and address measurement and standards needs across the flow cytometry application field
Enables members to work with NIST to develop measurement solutions and standards
Leverages NIST expertise in measurement science, standards development, reference materials, technology development, and basic research
Collaborates with related programs at other organizations
Cross-disciplinary expertise in engineering and the physical, information, chemical, and biological sciences
As a non-regulatory agency of the U.S. Department of Commerce, NIST does not impose standards; standards are accepted by consensus
Neutral convener for industry consortia, standards development organizations, federal laboratories, universities, public workshops, and interlaboratory comparability testing
Three working groups (WG) have been formed under the consortium to drive the development of standards, measurement assurance tools, best practices and methods, and advanced capabilities.