Biological samples range in complexities and require various considerations, formulations, and bioprocessing steps depending on intended utilization. As there are no ground truth reference materials for live cells, determining the accuracy of cell counting becomes challenging. Therefore, to increase the confidence of cell counting results, following the ISO cell counting standards is necessary to ensure the appropriate cell counting methods are selected and evaluated. In this webinar, we will discuss six key factors impacting the selection of a fit-for-purpose cell counting method and the quality of measurements, as described in the ISO Cell Counting Standard ISO 20391-1:2018 Biotechnology – Cell counting – Part 1: General guidance on cell counting methods. 1. Determine the intended use of the intended cell counting result 2. Investigate to understand cell sample composition 3. Methodologies of cell population identification 4. Cell counting system considerations 5. Cell counting process optimization 6. Consistent and robust operator training As a member of the US Technical Advisory Group, led by the National Institute of Standards and Technology (NIST) in collaboration with FDA, we have actively participated and contributed to the development of the ISO Cell Counting Standards 20391-1:2018 Part I and ISO 20391-2:2019 Part II: Experimental design and statistical analysis to quantify counting method performance.
