BEAM Phage ACT submits recommendations to improve European Pharmacopoeia Standards for bacteriophage potency testing

The BEAM Alliance’s Phage Action Collaborative Taskforce (PACT) has submitted a set of expert recommendations to the European Directorate for the Quality of Medicines (EDQM), aimed at refining the draft general chapter 2.7.38 on “Bacteriophage Potency Determination” in the European Pharmacopoeia.

This collective contribution, developed by experts from biotech companies, academia, and clinical practice, reflects the growing importance of phage therapy and the need for practical, science-based standards to support its safe and effective implementation across Europe.

Among the key proposals:

• Recognition of the spot test as a variation—rather than an alternative—to the double-layer agar (DLA) method, which remains the gold standard. The spot test is widely used in industry and offers efficiency and scalability, despite its inherent variability.
• Flexibility in bacterial strain selection for potency testing, especially in the context of multi-phage products or modern manufacturing methods, such as cell-free production.
• Clarification of technical requirements, including improved guidance on assay validation, acceptable variability, and system suitability criteria.

The submission emphasizes that quality control methods should be scientifically justified, flexible enough to reflect current industrial practices, and tailored to the specific characteristics of bacteriophages. It also encourages the EDQM to continue supporting innovation and practical application.

This contribution marks another step toward the integration of bacteriophage therapies into mainstream medicine, with PACT continuing to advocate for a regulatory framework that is both rigorous and fit-for-purpose.

If you wish to receive our contribution, send an email to: contact@beam-alliance.eu