Summary of the NIST-FDA Cell Counting Workshop: Sharing practices in cell counting measurements

Published

March 13, 2018

Author(s)

Sheng Lin-Gibson, Sumona Sarkar, John T. Elliott

Abstract

Cell-based technology is a fundamental pillar of modern biotechnology. Cells are used in drug discovery and validation, in the production of lifesaving medicines and high value materials, and more recently, as the therapeutic product itself, often referred to as cell therapy products (CTPs). With the development of CTPs, there is an increased needed for high quality, robust, and validated measurements for cell characterization. The translation of cell counting measurements from a research to a manufacturing settings has shifted the way the cell counting measurement is considered. The National Institute of Standards and Technology (NIST) has been working to develop strategies to improve the confidence of cell measurements critical for the translation, manufacturing and commercialization of CTPs. As part of these efforts, NIST and 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, with a focus on cell therapy applications. The workshop brought together approximately 50 experts representing cell counting device manufacturers, device users (CTP developers, contract manufacturing organizations, and academic translational centers), and government agencies, including the FDA that provided regulatory perspectives and NIST that discussed ongoing measurement assurance and standards efforts. This workshop report summarizes and further elaborates key discussion points raised by each group.

Citation

Biochemical Engineering Journal

Pub Type

Journals

Keywords

Cell counting, cell therapy product, workshop, standards, cell characterization, biomanufacturing

Citation

Lin-Gibson, S. , Sarkar, S. and Elliott, J. (2018), Summary of the NIST-FDA Cell Counting Workshop: Sharing practices in cell counting measurements, Biochemical Engineering Journal (Accessed March 20, 2025)