SHS Gesellschaft für Beteiligungsmanagement mbH
23. July 2025 - Newsletter

Additional market growth in sight for PathoQuest

At its 181st meeting in March 2025, the European Pharmacopoeia Commission (EPC) adopted a new general chapter entitled ” High-throughput sequencing for the detection of viral extraneous agents (2.6.41)”. The new chapter will be published in edition 12.2 of the European Pharmacopoeia (Ph. Eur.) in October 2025 and will enter into force on 1 April 2026.

High-throughput sequencing (HTS, also known as next-generation sequencing) is a state-of-the-art and sensitive molecular biology technology that is increasingly used to detect viral contaminants in biological products. Unlike conventional tests used for this purpose, HTS can detect a wide range of known and unknown viruses. HTS also offers advantages over traditional methods in terms of animal welfare, as it can be used instead of animal testing (in vivo testing). Identified as a top priority, the inclusion of this chapter demonstrates the EPC’s commitment to further modernising the European Pharmacopoeia and replacing in vivo testing wherever possible.

As one of the world’s leading providers of this technology, PathoQuest anticipates that the regulatory tailwind will enable the company to grow even stronger and replace animal testing in this field wherever possible.

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