The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on its new general chapter, HTS for the detection of viral extraneous agents (2.6.41), published in this quarter’s issue of Pharmeuropa (36.2) for comment.

High-Throughput Sequencing (HTS, also known as Next-Generation Sequencing) is a state-of-the-art and sensitive molecular biology technology increasingly used to test for viral extraneous agents in biological products. In contrast to conventional tests, this advanced technology can detect a broad range of viruses, both known and unknown. HTS can also offer advantages over conventional methods in terms of 3Rs/animal welfare as it may be used instead of in vivo tests.

The general chapter describes HTS methodologies used for the detection of viral extraneous agents in biological products. It outlines the different steps in the HTS workflow, the design of the method, analysis approaches, and the controls used in the routine test. Importantly, it provides guidelines for HTS method validation, including recommendations for the selection of the spiking material for validation and the evaluation of the relevant performance characteristics for HTS, as well as product-specific validation.

The new general chapter was elaborated by an international group of experts consisting of national competent authority, national control laboratory and industry experts, and is aimed at supporting users in implementing this new technology.

The Ph. Eur. would like to encourage all stakeholders to provide their comments on this draft chapter via the appropriate channel. The commenting period runs until 30 June 2024.

More information on how to comment can be found here: “Comment on drafts (Pharmeuropa)”.