Cells are being used in drug discovery, therapeutics development, biomedical research, and biotechnological and medical applications. However, the measurement challenges for these applications are complex and will be impeded by the complexity and dynamic nature of cells. The emergence of cell-based therapeutics has increased the need for high quality, robust, and validated measurements for cell product characterization. NIST serves as a neutral ground for the discussion of underpinning measurements and other manufacturing needs. Our effort aims to improve the confidence in cell measurements needed for translation and commercialization of cell-based products including cell therapy products (CTPs).
NIST collaborates with key stakeholders in industry, other government agencies, and academia to develop measurement assurance strategies and advanced measurement capabilities for cell characterization. Data and concepts developed through workshops and laboratory programs inform the development of standards.