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

Published: 15 February 2019
Expert Insight
Sumona Sarkar,
Sumona Sarkar
at National Institute of Standards and Technology (NIST)
Laura Pierce,
Laura Pierce
at National Institute of Standards and Technology (NIST)
Sheng Lin-Gibson,
Sheng Lin-Gibson
at National Institute of Standards and Technology (NIST)
Steven P Lund
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.

Read now