Reinventing the fight against bacteria, one phage at a time.

The European Medicines Agency Publishes Draft Guideline on Quality Aspects of Phage Therapy Medicinal Products: A Landmark in the Regulation of Bacteriophage Therapeutics Introduction On 16 October 2025 , the European Medicines Agency (EMA) , through its Committee for Medicinal Products for Human Use (CHMP) and the Biologics Working Party (BWP) , adopted for public consultation the draft Guideline on Quality Aspects of Phage Therapy Medicinal Products (EMA/CHMP/BWP/1/2024) . This 15-page document represents the first comprehensive regulatory framework in the European Union specifically addressing the quality, manufacturing, and control requirements for bacteriophage-based medicinal products intended for human use. The release of this draft guideline is a significant milestone in the development of phage therapy as a legitimate, standardised, and potentially widely accessible treatment modality for bacterial infections, particularly in the context of the global antimicrobial resi...

Upcoming Event — Phage Therapy Against Superbugs: Towards Real World Implementation The Graduate School of Medicine at Osaka Metropolitan University will host the international symposium, “Phage Therapy Against Superbugs: Towards Real World Implementation”, to commemorate the opening of Morinomiya Campus. In recent years, due to the spread of Antimicrobial-resistant bacteria, phage therapy—using viruses that infect bacteria—has gained worldwide attention. This symposium invites leading researchers from UC San Diego, one of the centers for clinical trials of phage therapy in the United States, to share cutting-edge insights. If you are interested, please feel free to join us.   Event Details Date & Time:   Saturday, November 8, 2025, 10:00 a.m.–12:00 p.m. Venue:  Auditorium, 3rd Floor, Morinomiya Campus Language:  English Capacity:  400 Registration:  Free / Register online by November 7 Registration Form Program   Lecture “Current Status of Phage T...

Consultation: Proposed GMP exemption for certain bacteriophage manufacture Overview Taken from :  https://walyanrespiratory.thekids.org.au/projects/phage-wa/helpful-links/ The Therapeutic Goods Administration (TGA) is seeking your feedback on a proposed time-limited GMP exemption for manufactures of personalised bacteriophage therapy products (BTPs).  In the last 5-10 years, increasing anti-microbial resistance (AMR) and medical device-related infections have led to the resurgence in interest from researchers and clinicians seeking access to experimental therapies for their patients. Unapproved BTPs are increasingly being considered. However, BTPs have not had their efficacy, safety or quality assessed by the TGA and are currently being supplied as unapproved goods under the Special Access Scheme (SAS) and Clinical Trial Notification (CTN) scheme provisions. The manufacturing process of BTPs is multifaceted and complex and there are no Good Manufacturing Practice (GMP) license...

New Wellcome Trust funding for Imperial Life Sciences and Medicine research view large Electron microscopy micrographs showing chimeric cf-PICIs Funding has been awarded to investigate the mechanisms driving bacterial evolution and explore novel strategies to combat antibiotic resistance. A team of Imperial scientists from Life Sciences and Medicine have received approximately £2.7 million through the  Wellcome Trust Discovery Award . The research focuses on capsid-forming phage-inducible chromosomal islands (cf-PICIs), a recently discovered mechanism by which bacteria exchange DNA across species. Cf-PICIs release small, tail-less capsids that can later acquire phage tails from unrelated bacteria, creating chimeric particles capable of transferring virulence and antibiotic resistance genes. "This recognition validates the importance of our discoveries on bacterial evolution and gives us the resources to take the next step: translating them into tangible advances against antibiotic...