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New general chapter on Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26) published for public enquiry

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European Pharmacopoeia
Monograph
News
02 June 2021
Strasbourg, France

The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the new proposed draft chapter on Cell-based assay for potency determination of TNF-alpha antagonists (2.7.26) published in this quarter’s issue of Pharmeuropa (33.2), for comment.

The Ph. Eur. Commission is presently conducting a pilot phase on the development of Ph. Eur. texts for therapeutic monoclonal antibodies (mAbs), exploring flexible concepts of standardisation of these complex biological medicines in an increasingly evolving multi-product market. Current Ph. Eur. initiatives focus on the development of “horizontal standards” to reflect key quality attributes and associated testing strategies, and to establish suitable common expectations and general methodologies applicable to a wide range or different classes of mAbs.

The rapidly growing number of TNF-alpha antagonists on the market has led to an increased variety of approaches to bioassay selection for assessing and comparing potencies of anti-TNF-alpha biologics and their biosimilars. Questions have been raised concerning the appropriate choice of potency assays for particular products and how they should be designed, conducted, analysed and applied.

This new general chapter – the first in a series of three planned new “horizontal standards” for mAbs – describes in detail the execution of four specific cell-based assay procedures and provides considerations on data analysis, system suitability, assay acceptance criteria and results evaluation, as well as best practices for the adjustment of assay conditions, addressing certain critical aspects. The chapter is the result of extensive experimental work, to verify the applicability of the selected bioassays as multi-product procedures suitable to assess the TNF-alpha inhibitory effect. The group of experts in charge of its elaboration – a group that brings together representatives from innovator and biosimilar companies, from National Control Laboratories, and from licensing authorities – and the EDQM hope that the draft chapter will provide users with valuable analytical tools and practical guidance to help ensure consistency and reproducibility of these cell-based assays, therefore contributing to standardise the different TNF-alpha antagonists available and in development.

All interested parties are strongly encouraged to review the draft, perform their own experimental verifications, wherever appropriate, and submit their comments, which will help shape the concept and ensure that it remains state-of-the art and can further develop towards future activities.

The deadline for comments is 30 June 2021.

For more information on how to comment, please consult our guide “How to comment”. Comments from within the member states are to be sent to the responsible national pharmacopoeial authority (NPA); comments from countries outside the Ph. Eur. convention or from industry associations may be sent to the European Directorate for the Quality of Medicines & HealthCare (EDQM) via the EDQM HelpDesk.

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