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Hospices Civils de Lyon (HCL) in France, has reached a major milestone in the development of therapeutic bacteriophage manufacturing after receiving authorization from the French National Agency for Medicines and Health Products Safety (ANSM) to produce therapeutic bacteriophages under Good Manufacturing Practice (GMP) standards.
The authorization, granted by ANSM on 28 May 2026 and publicly announced in June 2026, makes HCL the first public healthcare institution in France and the European Union authorized to manufacture therapeutic bacteriophages under GMP conditions for human use.
A milestone for regulated Phage manufacturing
The authorization follows the launch of the PHAGEinLYON programme in 2017, which brought together infectious disease specialists, microbiologists, pharmacists, researchers and clinicians with the objective of rebuilding a complete public phage therapy value chain in France that meets modern scientific and regulatory standards.
Under the authorization, HCL is permitted to manufacture Production Intermediates (Intermédiaires de Production – IP) for crude bacteriophages and Pharmaceutical Starting Materials (Matières Premières à Usage Pharmaceutique – MPUP) consisting of purified therapeutic bacteriophages intended for human use.
Manufacturing will be performed according to Good Manufacturing Practice (GMP), the pharmaceutical quality framework used for medicinal products.
Public manufacturing capacity
The authorization enables the production of therapeutic bacteriophage batches consisting of several hundred vials under pharmaceutical manufacturing standards.
According to HCL, this regulated manufacturing capability completes the public production chain required for therapeutic bacteriophage development from environmental isolation and characterization through pharmaceutical manufacturing and eventual clinical use.
Years of scientific development
The achievement represents the culmination of nearly a decade of scientific, pharmaceutical and clinical development carried out through the PHAGEinLYON programme.
Over this period, HCL teams have established expertise in:
- Environmental bacteriophage isolation
- Phage characterization
- Pharmaceutical quality control
- GMP manufacturing processes
- Clinical implementation of bacteriophage therapy
The programme has progressively developed the infrastructure required to manufacture therapeutic bacteriophages within a public hospital setting under pharmaceutical regulatory standards.
Supporting the future of Phage therapy
The authorization establishes a regulated public manufacturing capability that can support future clinical programmes and research activities involving therapeutic bacteriophages.
As antimicrobial resistance continues to drive interest in alternative antibacterial strategies, regulated GMP manufacturing remains one of the key components required for broader clinical implementation of phage therapy. The authorization granted to Hospices Civils de Lyon represents an important milestone in the development of regulated therapeutic bacteriophage manufacturing within the European Union
By establishing public-sector GMP manufacturing capability, HCL has demonstrated that therapeutic bacteriophages can be produced within a hospital-based pharmaceutical framework that complies with modern regulatory requirements for medicines.
