Worlds biggest
manufacturers
of bacteriophages

Phage therapy is moving from compassionate use toward regulated medicinal products. That makes one question hard to avoid: how can phages be manufactured to GMP standards while keeping the flexibility that personalised treatment needs?

Dr. Smrekar is CEO of JAFRAL and Vice President of PHAGE EUROPE. He addressed this question in a joint session with Dr. Frédérique Vieville of 5QBD Biotech.

From the lab to the clinic

His talk was titled “On GMP manufacturing of phage therapy products: scale-up challenges, batch consistency, regulatory interface for bespoke preparations.” It covered the practical realities of bringing phage therapy to patients:

• Scale-up and batch-to-batch consistency: how to keep product quality reproducible as production grows
• The regulatory interface for bespoke preparations: how patient-specific phage products can fit into a regulatory framework
• Development pathways: the route a phage product takes from early research to clinical use
• Investment, IP and partnerships: the business models and collaborations that can keep phage therapy viable over the long term

Experience from both sides

Phages are at the core of what JAFRAL does. We manufacture phages for our partners and develop our own phage products, so we know these challenges from both sides: as a manufacturing partner and as a product developer. Workshops like this let us share that hands-on experience directly with the people shaping the future regulatory framework.

Moving forward together

Phage therapy can only make the step to regulated products if manufacturers, regulators and the clinical community work it out together. The EMA workshop was a valuable chance for exactly that kind of exchange, and we were glad to help shape a workable path for phage therapy in Europe.

We thank the European Medicines Agency for organising the workshop, Dr. Frédérique Vieville for a great joint session, and everyone who took part.

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