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NIST Flow Cytometry Standards Consortium 


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        


  • 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 contribution of equivalent value 

Notice of NIST's Flow Cytometry Standards Consortium   



Illustration of a field of cells, a biomanufacturing assembly line, a flow cytometry device and a handshake.
Credit: B. Hayes/NIST

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

Current Activities  

Four 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.

Flow Cytometry Consortium Working Group Graph
  • WG1: 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, and drive cytometer standardization
    • The first interlaboratory study on ‘Cross calibration with ERF bead sets and ERF assignment to unknowns’ – Data submission near completion
  • WG2: Design and conduct interlaboratory studies for the development of reference standards, control materials, and best practice protocols to achieve assay standardization and reference data generation  
    • The first interlaboratory study on ‘Standardization of a TBMNK assay on cell count and health’ – Data submission near completion
  • WG3: Build infrastructure and capability for flow cytometry data repository and standardized reporting and multi-modal simultaneous data analysis
    • Data repository infrastructure with NASA’s Jet Propulsion Laboratory, California Institute of Technology near completion
  • WG4: Developing measurement solutions and standards for gene delivery systems to improve measurement confidence by establishing traceability and assisting measurement comparability ​ 
    • Planning first interlaboratory study to include measurements of capsid titer, genomic titer, particle concentration, and orthogonal measurements


Created November 2, 2020, Updated June 17, 2024