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.
Key Words
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References
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ISO. Reference materials—good practice in using reference materials guide 33.
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Article info
Publication history
Published online: April 23, 2018
Accepted:
March 13,
2018
Received:
January 12,
2018
Identification
Copyright
Published by Elsevier Inc. on behalf of International Society for Cellular Therapy.
