ISCT Webinar: Measurement Assurance for Cell Enumeration
Organized by the ISCT North American Legal and Regulatory Affairs (LRA) Committee
Date: Wednesday, April 29th, 2015
Time: 9:00 AM PT, 12:00 PM ET, 5:00 PM BST,6:00 PM CEST
Chair: Michael Mendicino, PhD, Mesoblast, United States
Speaker: Sumona Sarkar, PhD, National Institute of Standards and Technology, Biosystems and Biomaterials Division, United States
About the Webinar:
Cell enumeration is a fundamental measurement in the biological sciences with implications for cell therapy and regenerative medicine. By increasing our confidence in fundamental measurements in the biological sciences, we may be able to improve reproducibility of our results and aid the translation of scientific advances to the medical field.
New measurement platforms have been developed to increase the throughput of cell counting and to improve precision in the measurements. However, due to complex biological properties as well as operator, equipment, and procedure variations, there are often discrepancies between counts acquired via various measurement processes, reducing confidence in the measurement. Additionally it is difficult to envision an appropriate reference material or reference measurement to address the accuracy of cell counting given the diverse, complex and dynamic nature of cell suspensions.
In this webinar we will present our recent efforts in developing a new approach to improve the confidence of cell counting measurements independent of the measurement platform. Specifically, we will describe an experimental design and statistical analysis framework that can be used to evaluate the performance of a cell counting measurement process in the absence of a reference method, ground truth cell number, or reference material. The analysis produces a performance metric, which is derived from the basic assumptions that an accurate and reproducible counting method will have a proportional response to changes in dilution and be repeatable. This metric may be useful in characterizing the performance of a chosen cell count measurement process, and may be useful when making critical decisions on which measurement process to utilize for a given cell preparation.
We will discuss considerations that must be made for the experimental design and statistical analysis, and give examples of the analysis. This method to validate cell counting measurements is the basis for a new International Standard under consideration within ISO/TC 276: Biotechnology, where a package of standard for cell counting is under development. We will discuss these current standardization efforts as well as industry partnerships. Additionally, future directions will be addressed.
- Discuss challenges associated with obtaining accurate and reproducible cell counting (both total count and differential count)
- Describe strategies for achieving measurement assurance in the absence of a reference material, including an experimental and statistical design to assess to the overall confidence in the cell count measurement
- Solicit input for an international standardization effort (within ISO/TC 276) for cell counting standards