- Are the cells healthy and likely to respond in a meaningful fashion to the treatment?
- What changes in their characteristics are relevant to their response to the experiment?
- How can one quantify that change in a way that allows comparison of data from different laboratories?
- Is the methodology for making these measurements repeatable in different laboratories?
Comparison of data from different labs requires cell line identification and authentication. NIST is developing markers that can be made into kits for distinguishing lines from rat, mouse, primate, and hamster. NIST benchmarking materials and protocols for flow cytometers and fluorescence microscopes make it possible to compare the response of instrumentation from day to day and lab to lab. We also develop and test the accuracy of image analysis methods for quantifying cellular characteristics such as morphology.
Because dynamic measurements are important for understanding biological processes, we develop robust methods for quantitative time-lapse microscopy of cells, including stem cells. Reliable measurement methods are needed for confident decision-making at all stages of stem cells development, from the research bench to manufacturing and clinical applications. To address this challenging field, we are developing new approaches and documentary standards for cell therapies and other regenerative medicine applications including for the evaluation and comparison of cell counting methods. NIST is also examining methods that will allow for the validation of stem cell markers and other characteristics that might provide the basis for potency and release assays.
New label-free imaging technologies, such as BCARS and SPR imaging, are being developed as methods for quantifying cellular characteristics including molecular composition and secretion of extracellular matrix protein.
- 3-dimensional responses of mesenchymal stromal/stem cells to scaffolds
- Time-dependent examination of gene expression in embryonic stem cell colonies
- Quantifying surface marker expression in pluripotent stem cells