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Summary of the National Institute of Standards and Technology and US Food And Drug Administration cell counting workshop: Sharing practices in cell counting measurements

Published:April 23, 2018DOI:https://doi.org/10.1016/j.jcyt.2018.03.031

      Highlights

      • NIST and FDA held a workshop to address cell counting/characterization for CTPs.
      • Cell counting is a fundamental and challenging measurement for CTP characterization.
      • Workshop participants addressed counting method selection, development and validation.
      • Cell counting methods should be developed in a fit-for-purpose context.
      • Community-driven efforts are necessary for reference material and standards development.

      Abstract

      The emergence of cell-based therapeutics has increased the need for high-quality, robust and validated measurements for cell characterization. Cell count, being one of the most fundamental measures for cell-based therapeutics, now requires increased levels of measurement confidence. The National Institute of Standards and Technology (NIST) and the US Food and Drug Administration (FDA) jointly hosted a workshop focused on cell counting in April 2017 entitled “NIST-FDA Cell Counting Workshop: Sharing Practices in Cell Counting Measurements.” The focus of the workshop was on approaches for selecting, designing and validating cell counting methods and overcoming gaps in obtaining sufficient measurement assurance for cell counting. Key workshop discussion points, representing approximately 50 subject matter experts from industry, academia and government agencies, are summarized here. A key conclusion is the need to design the most appropriate cell counting method, including control/measurement assurance strategies, for a specific counting purposes. There remains a need for documentary standards for streamlining the process to develop, qualify and validate cell counting measurements as well as community-driven efforts to develop new or improved biological and non-biological reference materials.

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