Advanced therapies (cell, gene and regenerative medicine) have shown promising clinical efficacy and are changing the paradigm for treating diseases and injuries. However, there is a need for reliable methods to assess attributes of cell-based products. Regulatory filings contain many types of measurement data to define product quality, safety and efficacy. For mammalian cells, measurements of cell count, viability, and function are major parts of these datasets. At BBD, we develop measurement assurance strategies and technologies to improve confidence in cell measurements that support standards development and enable translation and commercialization of cell-based products.
Current Activities and Products
- Prototype Cell Assay Measurement Platform (P-CAMP): Innovative automated system that enables direct evaluation of how variability in the measurement process influences the cell assay test result.
- Cell Counting: Strategies that combines experimental design and statistical analysis to evaluate the confidence in the cell counting measurement process
- Quantitative Flow Cytometry: Standardization of flow cytometry measurements with the use of reference controls and standards, and measurement procedures.
- Cell Line Identification and Authentication: Validation of NIST’s patented mouse authentication method
- Fluorescence Microscope Benchmark: A method to characterize a fluorescence microscope's performance by benchmarking the detection threshold, saturation and linear dynamic range to a physical artifact
- Quantitative Phase Imaging- Reference materials and methods to enable quantitative characterization of QPI for cellular imaging.
- BCARS and SPR Imaging: Methods for quantifying cellular characteristics including molecular composition and secretion of extracellular matrix protein
- Measurements for Intracellular Signaling Pathways in iPSCs: Fluorescent protein reporter cell lines, large field of view live cell imaging, and mathematical modeling to directly monitor signaling pathway activity in iPSCs