- •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.
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
- Understanding and managing sources of variability in cell measurements.Cell Gene Ther Insights. 2016; 6: 663-673
- Defining quality attributes to enable measurement assurance for cell therapy products.Cytotherapy. 2016; 18: 1241-1244
- Strategies for achieving measurement assurance for cell therapy products.Stem Cells Transl Med. 2016; 5: 705-708
- ISO/TC 276 Biotechnology. ISO 20391-1:2018 Biotechnology—Cell counting—Part 1: General guidance on cell counting methods.2018
- Validation of analytical procedures: text and methodology.in: Secretariat I. ICH Harmonised Tripartite Guideline. ICH, Geneva, Switzerland2005
- International vocabulary of metrology—basic and general concepts and associated terms (VIM).3rd ed. Joint Committee for Guides in Metrology (BIPM), 2012
- Evaluating the quality of a cell counting measurement process via a dilution series experimental design.Cytotherapy. 2017; 19: 1509-1521
ISO. Reference materials—good practice in using reference materials guide 33.
USP. Flow cytometric enumeration of CD34+ cells—appearing in USP 40 <127>.