NIST Gets Going With the Flow Cytometry Standards Consortium

Advances in cell and gene therapies are revolutionizing health care by providing curative treatments for previously untreatable diseases. To help develop standards and measurements to support the discovery and manufacture of these groundbreaking therapies, NIST is launching the Flow Cytometry Standards Consortium. Beginning with a workshop the afternoons of Feb. 16 and 17, the consortium will convene stakeholders in the health care and biotechnology communities to solve common measurement problems related to this technology. We sat down with National Institute of Standards and Technology (NIST) chemist Paul DeRose to discuss the consortium in more detail.

What is flow cytometry, and what is it used for?

Flow cytometry is an incredibly powerful technique used to measure the chemical, physical and biological characteristics of cells and constituents of cells, as well as particles of biological and nonbiological origin. Flow cytometry is widely used in the characterization and testing of advanced therapies, including cell and gene therapy products. Additionally, flow cytometry is a critical tool in clinical diagnostics, vaccine and drug development, cancer research and diagnosis, and other areas of the biosciences and biotechnologies.

Why do we need standards for flow cytometry?

A big challenge is the lack of reproducibility, and therefore comparability, of results from flow cytometry. While the clinical diagnostics community has taken painstaking measures to lock down the entire measurement workflow to ensure the necessary confidence, we need to develop measurement assurance strategies and standards to promote broader quantitative applications of flow cytometry. Standards for flow cytometry will enable more accurate quantitation and improve reproducibility and comparability of measurement results. These capabilities will ultimately accelerate the translation of research into new treatments for patients.

Why do we need a consortium to develop standards for flow cytometry? Why can’t NIST or industry do this on their own?

The NIST-led consortium provides a neutral forum for stakeholders in the biotechnology and health care sectors to identify and address common measurement challenges, exchange ideas and jointly accelerate the development of standards and reference materials for quantitative flow cytometry. The community can benefit from NIST’s expertise in measurement science to supply reliable measurement solutions with built-in high accuracy and measurement confidence. NIST can better advance its mission through improved understanding of various real-world processes and limitations through this effort.

What special capabilities does NIST bring to this area?

We have extensive experience coordinating various stakeholder communities to develop pre-competitive measurement solutions for regenerative medicine and advanced therapies. In the area of flow cytometry, NIST has deep expertise in fluorescence measurement and has been supplying high-accuracy measurements to the community for nearly 20 years. We have recently developed SI-traceable particle counting techniques that will be a critical piece of the consortium work. Moreover, NIST has built a state-of-the-art measurement infrastructure for deep characterization of cells using multi-omics technologies (genomics, transcriptomics, proteomics, etc.).

What kinds of consortium members are you looking for? What will you be asking of them?

NIST is looking to engage members across the regenerative medicine and advanced therapy fields including stakeholders from industry, academia and government with expertise in the development and manufacturing of cell and gene therapies as well as associated reagents, materials/biomaterials/measurement technology, and biological assays for flow cytometry applications. We will be asking them about their standardization and measurement needs and how we can collaborate to advance cell and gene therapy and beyond.