Increased rigor in measurements is widely recognized as a critical need to advance biosciences and biotechnology and increase the return on our Nation’s research investments. Measurements are fundamental from scientific discovery to manufacturing and commercialization, yet many questions remain. Does the measurement provide sufficient information for a conclusion? How accurate and reproducible are the measurements? Do we have sufficient understanding and control of the entire measurement process, from pre-analytical step to analysis, as well as the overall uncertainty of the results? There has been an increased call for standards (guides and methods) to enable data comparability, yet the above questions must be addressed prior to the development of standards (Figure 1).
Measurements of living systems pose significant and unique challenges. Biological systems are composed of heterogeneous and dynamic living entities whose properties can fluctuate with time. In addition, any changes in process, such as sample handling procedures or matrix and reagent composition can affect various attributes. These complexities require new strategies to be added to analytical approaches that have served traditional metrology.
We work closely with industry, federal agencies, academia, as well as international metrology institutes and standards organizations to establish measurement assurance strategies for complex biological measurements. We carry out this work through fundamental measurement science, including the development of reference materials, reference data, and protocols, as well as the development of novel advanced measurement capabilities. Many of our current efforts are focused on emerging biotechnology products and processes.
Examples of applications of measurement assurance strategies include:
Cell Characterization: Design and Method Selection