Back Public consultation on a new general chapter 2.6.42. Test for procoagulant activity in immunoglobulin preparations in Pharmeuropa 37.3

EDQM Strasbourg, France 18/07/2025
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Public consultation on a new general chapter 2.6.42. Test for procoagulant activity in immunoglobulin preparations in Pharmeuropa 37.3

The European Pharmacopoeia (Ph. Eur.) has published a draft of a new general chapter, 2.6.42. Test for procoagulant activity in immunoglobulin preparations, for public consultation in the current issue of Pharmeuropa (37.3). Stakeholders are invited to submit their comments by the end of September 2025.

This new chapter has also been referenced in two revised monographs – Human normal immunoglobulin for subcutaneous administration (2788) and Human normal immunoglobulin for intravenous administration (0918) – which are likewise open for comment in Pharmeuropa 37.3.

Procoagulant activity (PCA) in immunoglobulin preparations, typically caused by activated human coagulation factor XI (FXIa), poses a potential safety concern. The new general chapter describes three methods for the detection of procoagulant activity in immunoglobulin preparations: a chromogenic substrate assay (CSA) specific to FXIa, and two methods – the thrombin generation assay (TGA) and the non-activated partial thromboplastin time (NAPTT) assay – which can also identify other potential procoagulant impurities. It provides guidance on method implementation, including overcoming matrix effects and the use of appropriate controls, as well as recommendations for selecting an appropriate substrate plasma.

This general chapter has been elaborated based on two collaborative studies; the resulting article on the CSA study has already been published in Pharmeuropa Bio & Scientific Notes, while a publication on the TGA is forthcoming. A comprehensive description of the NAPTT assay will be added once the corresponding collaborative study is complete.

Stakeholders are encouraged to review the draft text and provide their feedback. For more information on how to comment, please consult the “How to comment” guide. Comments from interested parties from member states of the European Pharmacopoeia 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.