Europe – Revised Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29) in Pharmeuropa 34.1

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapters Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and viability (2.7.29), published in this quarter’s issue of Pharmeuropa (34.1) for comment (deadline 31 March 2022).

Both chapters have been updated to include new automated technologies and to improve the standardisation of the analytical procedures. A validation section has also been included in these two texts. It corresponds to accepted scientific practice and current recommendations on analytical validation such as ICH Q2 guideline (R1).

As a result, the Nucleated cell count and viability (2.7.29) chapter now describes image cytometry technologies. A table summarises the main characteristics of image cytometry and flow cytometry, as they are the most commonly used techniques for automated counting and viability. Another table was also included to briefly describe the spectral properties of commonly used dyes, their modes of action and the methods in which they are used…