ISO Publishes Part 2 of SCB-Coordinated Standard on Cell Counting

We are proud to announce the publication of Part 2 of the SCB-coordinated ISO standard on cell counting, titled ISO 20391-2:2019: Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance.

Cell counting is fundamental to the regenerative medicine product development process. Most major indicators of product quality, such as purity and potency, depend on an accurate count of the number of active therapeutic cells within the product. However, there are many different cell counting methods and measurement processes, each with different advantages and drawbacks. It can be difficult for researchers and product manufacturers to evaluate the best cell counting method for a particular application.

The new standards in this area will help stakeholders improve the precision of their cell counting methods, allowing more accurate assessments of product quality and an improved ability to compare different data sets to support product innovation. Because so many other quality attribute measurements rely on cell counts, this standard will also provide a strong foundation for the development of additional standards needed in the field, such as for cell characterization.

Part 1 of the standard, ISO 20391-1:2018: Biotechnology — Cell counting — Part 1: General guidance on cell counting methods, was published in January 2018. It provided general guidance for cell counting processes, including method selection and measurement validation. The newly published Part 2 outlines a series of quality indicators that stakeholders can use to evaluate a specific cell counting measurement process for use.

Several current SCB board members joined the cell counting standard working group headed by the National Institute of Standards and Technology (NIST) in 2014, when Part 2 of the standard was beginning to move through the ISO development process. As SCB matured as an organization, it formalized its support of the advancement process, soliciting comments and gathering input from the community to increase buy-in and ensure the standard fully addressed the needs of stakeholders. This support ultimately helped to accelerate the standard effort. During this time, Part 1 of the standard was published, and SCB helped to inform the broader community of its availability and promote its adoption.

ISO 20391-2 is the second SCB-coordinated project to advance to publication since we formally launched our coordination efforts in early 2018. We are excited to see more standards becoming available and are proud to play a role in ensuring that the regenerative medicine community is fully engaged in the development process and can see their inputs reflected in finished standards. With the publication of ISO 20391-2, we will continue to conduct outreach to raise awareness of both parts of the standard and how they can contribute to accelerated innovation in the regenerative medicine field.

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If you would like to get involved in any of our ongoing standards advancement projects, we are always looking for expert input and feedback. To learn more, please contact SCB.