The European Pharmacopoeia Commission (EPC) has adopted a new general chapter relating to high-throughput sequencing (HTS) for the detection of viral extraneous agents in biologics.
Adopted during the regulatory organisation's 181st session in March 2025, the chapter touts the advantages of HTS over conventional methods — specifically their lack of reliance on animal testing.
Used instead of in vivo tests, HTS methodologies can detect viral extraneous agents in biologics, including vaccines, viral vectors, cell-based preparations and recombinant proteins.
In contrast to conventional tests, HTS are highly sensitive to a broad range of viruses.
The new general chapter depicts optimal HTS methodologies, including:
- Method design
- Analysis approaches for genomics, viromics and transcriptomics applications
- Controls used in routine testing
- HTS method validation
- Recommendations for selecting spiking materials
- Evaluation of the relevevant performance characteristics for HTS
- Product-specific validation
The chapter was created by an international group of experts comprising representatives of national authorities, control laboratories and industry members, and is intended to support biopharmaceutical and biotech companies in implementing this new technology.
Its introduction, according to the European Pharmacopoeia Commission, was a top priority for the organisation between 2023 and 2025, and aims to reduce European pharma's reliance on in vivo tests wherever possible.