France launches its first public GMP platform to produce large batches of therapeutic phages at affordable scale

France launches its first public GMP platform to produce large batches of therapeutic phages at affordable scale

Frédéric Laurent, Hospices Civils de Lyon, France

A national initiative aiming to transform phage therapy from experimental promise into accessible clinical treatment.

Prof. Frédéric Laurent (Hospices Civils de Lyon, France) is leading one of the most ambitious initiatives in Europe to make therapeutic bacteriophages available at clinical scale. His work focuses on building France’s first public platform dedicated to the GMP-compliant production of therapeutic phages, a critical step for the future of phage therapy.

Prof. Laurent will present the full scope of this initiative at the international meeting Targeting Phage Therapy 2026, which will take place June 9–10, 2026 in Valencia, Spain, bringing together scientists, clinicians, and biotechnology innovators working to advance phage-based medicine.

Phage therapy the use of viruses that specifically infect and destroy bacteria is widely viewed as a promising response to the global crisis of antibiotic resistance. However, one major obstacle has slowed its clinical adoption: the ability to produce therapeutic phages at large scale under strict pharmaceutical standards.

The PHAG-ONE project, supported by the French National Research Agency (ANR), aims to address this challenge by creating a national public infrastructure capable of manufacturing large batches of stable, safe, and affordable GMP-grade phages. These phages are intended to be accessible to clinicians throughout France and potentially across Europe.

From environmental discovery to clinical-grade production

The platform integrates the entire pipeline required to transform environmental bacteriophages into regulated therapeutic products.

Phages are first isolated from environmental sources and screened using high-throughput approaches to identify candidates with strong antibacterial activity. Clinical bacterial collections from the French National Reference Center for Staphylococci are used to ensure broad coverage of pathogenic strains.

Selected phages undergo genomic characterization to confirm that they are strictly virulent and safe for therapeutic use. Production then proceeds using prophage-free bacterial production strains, followed by purification and formulation through tangential flow filtration, generating stable GMP-grade preparations.

All required quality control procedures have been developed and validated internally according to the standards of the French National Agency for Medicines and Health Products Safety (ANSM), allowing regulatory-compliant batch release.

First therapeutic batches successfully produced

The platform has already produced three GMP pilot batches of four therapeutic phages targeting Staphylococcus aureus, a major pathogen responsible for severe hospital infections.

These phages collectively cover 88% of the species’ genetic and clinical diversity.

Each batch met all regulatory quality requirements and demonstrated excellent safety in preclinical intravenous studies in rabbits, with high tolerance and no observed toxicity.

Preparing clinical deployment

The next stage of the project will focus on compassionate-use treatments in patients, accompanied by cohort monitoring and the preparation of future clinical trials.

Researchers are also developing new delivery strategies to expand therapeutic applications, including:

  •  Hydrogels enabling slow local release from bone substitutes or prosthetic reservoirs
  • Nebulization systems for pulmonary administration
  • 3D-printed patches for skin diffusion
  • 3D-printed oral pellets designed for gut decolonization of multidrug-resistant bacteria

A strategic milestone for the future of phage therapy

The PHAG-ONE initiative represents a crucial step toward integrating bacteriophages into modern infectious disease medicine. By combining GMP manufacturing, regulatory validation, and clinical deployment strategies, the platform could become a European reference model for scalable public production of therapeutic phages.

During Targeting Phage Therapy 2026, Prof. Frédéric Laurent will discuss how this infrastructure could help overcome one of the most important bottlenecks in the field:

the transition from experimental phage therapy to a reliable, standardized, and accessible medical treatment.

Targeting Phage Therapy 2026
April 9-10, 2026
 – Valencia, Spain

www.phagetherapy-site.com