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Material Measurement Laboratory

Biosystems and Biomaterials Division

Extracellular Vesicles Focus Areas

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To enhance measurement reliability in extracellular vesicle (EV) technology, NIST's flow cytometry research focuses on:

  1. Standardized cell-based platforms for production of EV therapeutics.
  2. Evaluation of liquid biopsy, dairy, and other alternative EV sources, either internally or in collaboration with external stakeholders, for EV generation and characterization.
  3. Robust isolation and characterization methods for analyzing EVs including differential ultracentrifugation, ultrafiltration, precipitation, and size exclusion chromatography.
  4. Assessment of EV biomarkers of malignant tumors (e.g., Her2, KRAS, etc.) and other disease states using consented cancer cell samples and relevant NIST Standard Reference Materials™ (NIST SRM™s).
  5. Standardized measurement systems for assessing EV molecular composition and biological activity.
  6. Reference materials for validating EV measurements and ensuring quality throughout production.
Schematic showing how cell cultures and clinical specimens can be subjected to preparation methods that produce EVs of high quality for flow cytometric and orthogonal characterization to produce candidate EV reference materials.
Process for reliable measurements of extracellular vesicles using flow cytometry and other orthogonal analytical methods.  A. standardized cell-based platforms or alternative EV sources (e.g., blood, serum, urine, cell culture, plants, dairy, etc.); B. robust isolation and purification methods; C. characterization methods for analyzing EVs and standardized measurement systems for assessing EV molecular composition and biological activity; D. assessment of EV biomarkers of malignant tumors (e.g., Her2, KRAS, etc.) and other disease states; D1. super-resolution nanoparticle micrograph showing tetraspanin (TS) proteins (CD9, CD63, and CD81); D2. flow cytometry analysis of GFP+ and TS-APC+ EVs; D3. imaging flow cytometry showing a single GFP+ (left) and TS APC+ EV (center) cell including color overlay (right); E. goal to produce reference materials for benchmarking and validating EV measurements.

Return to the Quantitative Flow Cytometry Measurements Program page.

Bioscience, Bioeconomy, Biomanufacturing, Cell measurements, Health, Cell and gene therapy, Regenerative medicine and advanced therapy and Flow cytometry
Created February 9, 2025, Updated April 15, 2025