Back Revised general chapter 2.7.24 Flow cytometry in Pharmeuropa 35.4

EDQM Strasbourg, France 17/10/2023
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Revised general chapter 2.7.24 Flow cytometry in Pharmeuropa 35.4

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapter Flow cytometry (2.7.24), published in this quarter’s issue of Pharmeuropa (35.4) for comment (public deadline 31 December 2023).

The revision of this general chapter is of high importance since it will facilitate the use of a major technique, flow cytometry, to detect and analyse the chemical and physical attributes of a population of cells or particles. Flow cytometry is a powerful tool that can be applied to a wide range of products and therefore contributes significantly to patient safety.

The general chapter 2.7.24 Flow cytometry has been updated to reflect current techniques. The text provides important information on technical considerations (including equipment description and system selection), sample preparation and data analysis. It also supports users by giving examples of flow cytometry applications, as well as recommendations regarding qualification and validation. Additional information has been inserted throughout the text. For instance, the chapter now covers the analysis of small particles (e.g. exosomes and viral particles) and includes a table summarising fluorescent dyes and fluorochromes commonly used in flow cytometry, together with an example of a stepwise procedure to establish compensation.

All users and interested parties are encouraged to review the draft and submit their comments before the deadline of 31 December 2023.

For more information on how to comment, please consult our guide “How to comment”. Comments from states parties to the Ph. Eur. Convention should be sent to the responsible national pharmacopoeia authority (NPA); comments from other countries or from industry associations should be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.

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