New BP Guidance Supports Safer Viral Vector Testing in ATMPs
Published 16 October
The British Pharmacopoeia (BP) has published new best practice guidance for Replication Competent Virus (RCV) testing, supporting safer development of Advanced Therapy Medicinal Products (ATMPs).
As the use of viral vectors in ATMPs continues to grow, ensuring these vectors are not replication-competent remains a critical safety step. However, existing recommendations often lack clarity or relevance for the diverse range of vectors in use today. To address this, the BP has developed targeted guidance that offers practical, non-mandatory advice for testing replication competency in commonly used viral vectors such as Adeno-Associated Virus (AAV) and Lentivirus (LV).
This new guidance was developed in partnership with a working party of experts from the MHRA, NHS, industry, and academia. It provides a harmonised framework aligned with existing standards, while allowing organisations the flexibility to tailor assays to their specific needs.
Key features:
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Expert-led development: Created with input from leading professionals across regulatory, clinical, and academic sectors.
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Vector-specific advice: Covers best practices for AAV and LV vectors, recognising the varied risks associated with different types.
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Flexible and practical: Offers a trusted framework that supports innovation while maintaining safety and consistency.
Available in both PDF and in the British Pharmacopoeia 2026 online, alongside the Ph. Eur. 12.1 update.
This guidance is part of BP’s ongoing commitment to supporting innovation in medicines development while maintaining high standards of safety and quality.