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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

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Standards Landscape in Cell Counting: Implications for Cell & Gene Therapy

Cell Therapy Quality/ CMC & Analytics

Sumona Sarkar, Laura Pierce, Sheng Lin-Gibson & Steven P Lund

Recent advances in the fields of cell and gene therapy and regenerative medicine have increased the need for a standardized approach to cell counting. International efforts in the development of documentary standards as well as workshops which include input from device manufacturers, regulators, researchers and manufacturing organizations have sought to increase confidence in cell count measurements. Improving comparability between methods, enabling fit-for-purpose method selection, and facilitating the translation of cell counting measurements between stages of product development are critical for the success of cell and gene therapy products. Here, we describe recent efforts in the area of standards development for cell counting and outline a technical approach for the comparison and selection of cell counting methods in the absence of reference materials. These standards and approaches offer strategies for the development and implementation of counting methods that are fit-for-purpose to address the broad needs of cell and gene therapy and regenerative medicine.

DOI: 10.18609/cgti.2019.016
Submitted for review: December 11, 2018
Citation: Cell & Gene Therapy Insights 2019; 5(1), 117–131
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