Abstract
Abstract The importance of cell counting has increased significantly in the last decade due to the major advances in the fields of cell and gene therapy, biologics production, and regenerative medicine. This has necessitated the development of a standardized approach to cell counting assays. In recent years, the U.S. Food and Drug Administration (FDA), in collaboration with the National Institute of Standards and Technology (NIST) and the International Organization for Standardization (ISO), has launched an effort to standardize cell counting methods to improve the confidence in cell counting measurements. There is a wide range of biological sample types, various formulations, and bioprocessing steps for cell and gene therapy products. Furthermore, there are no ground truth reference materials for live cells, making the determination of accuracy of cell counting difficult defined in the ICH Q2 (R1). Therefore, in order to increase the confidence of cell counting results, it is critical to follow the two recently published ISO cell counting standards to ensure cell counting methods are tailored to the specific sample and purpose.In this work, we will provide insights and guidance for the ISO standards for method selection. The important aspects of the ISO cell counting standards have been distilled to six key factors for selecting the cell counting methods. Attention to these details will allow researchers to more easily adhere to the ISO recommendations to ensure high quality cell counting measurements, and in doing so, sites can meticulously document their rationale, process, and data results. Citation Format: Leo Chan, Jordan Bell, Bo Lin. Practical cell counting method selection to increase the quality of cell counting results [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 2098.
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