- New general chapter on Phage therapy medicinal products (5.31) adopted
– The European Pharmacopoeia Commission (EPC) has adopted a new general chapter on Phage therapy medicinal products (5.31). This adoption is part of the EPC’s top priorities for the years 2023-2025 to standardize requirements for phage therapy.
– URL: https://www.edqm.eu/en/w/new-general-chapter-on-phage-therapy-medicinal-products-5.31-adopted-and-pre-published-on-the-edqm-website
- In vitro studies for a better understanding of bacteriophage-bacteria interactions
– PhD research by Julia Egido at UMC Utrecht has shown that bacteriophages may act synergistically with certain antibiotics to kill bacteria. However, the human complement system can inhibit certain phages, which may compromise their antibacterial activity.
– URL: https://www.umcutrecht.nl/en/over-ons/nieuws/details/apr-3-in-vitro-studies-for-a-better-understanding-of-bacteriophage-bacteria-interactions
- Regulatory Roadmap for Phage Therapy under EU
– The regulatory roadmap for phage therapy under the EU discusses the submission settings of phage therapy,including one-fits-all in advance versus patient-specific on-demand approaches. The therapy is still experimental and has specific criteria that must be met, such as the infection being caused by only one bacterium at a time and no other therapeutic treatments being possible.
– URL: The medicinal Phage—Regulatory Roadmap for Phage Therapy under EU
Standardizing Phage Therapy: Insights from a Specialist
Table of Contents
Phage therapy, a promising alternative too conventional antibiotics, is gaining traction globally. Recent developments in Europe have set new standards for the use of bacteriophages in medicinal products. This interview with Dr. amelia Hartley,an expert in phage therapy,delves into the latest advancements and challenges in this field.
New General Chapter on Phage Therapy Medicinal Products (5.31) Adopted
European Pharmacopoeia Commission’s New Standards
Senior Editor (SE): Dr. Hartley, coudl you provide an overview of the new general chapter on phage therapy medicinal products (5.31) adopted by the European Pharmacopoeia Commission (EPC)?
Dr. Amelia Hartley (AH): Certainly. The adoption of this new chapter is a notable step towards standardizing phage therapy. The EPC has recognized the need to establish clear guidelines for the production,quality control,and use of phage-based medicinal products. This will help ensure the safety and efficacy of these therapies.
Impact on Phage Therapy Development
SE: How do you think this will impact the development of phage therapy in Europe?
AH: this adoption will undoubtedly accelerate the development and approval process for new phage therapies. With standardized requirements, researchers and pharmaceutical companies can focus on innovation and clinical trials, knowing that they have a clear regulatory framework to follow.
In Vitro Studies for a Better Understanding of Bacteriophage-Bacteria Interactions
Synergistic Effects with Antibiotics
SE: Can you discuss the recent findings from Julia Egido’s PhD research at UMC Utrecht regarding bacteriophage-bacteria interactions?
AH: Julia Egido’s research has been quite revealing.It shows that bacteriophages can act synergistically with certain antibiotics to kill bacteria more effectively. This is a promising finding, as it suggests that phage therapy could be combined with traditional antibiotics to enhance their efficacy.
Human Complement System’s Role
SE: Though, the research also highlights that the human complement system can inhibit certain phages. How does this affect the potential of phage therapy?
AH: Yes, that’s correct. The human complement system can sometimes interfere with the antibacterial activity of phages. This is a challenge that needs to be addressed in the development of phage therapies. Understanding these interactions is crucial for designing effective and safe phage-based treatments.
Regulatory Roadmap for Phage Therapy under EU
Submission Settings and Criteria
SE: What are the key points from the regulatory roadmap for phage therapy under the EU?
AH: The regulatory roadmap outlines two main submission settings for phage therapy: one-fits-all in advance versus patient-specific on-demand approaches. Currently, phage therapy is still experimental and has specific criteria, such as infections caused by only one bacterium at a time and no other therapeutic treatments being possible.
Future Directions
SE: What are the future directions for phage therapy under the EU?
AH: The future looks promising. As research continues and more data is gathered,we can expect the criteria for phage therapy to become more flexible. This will allow for a wider range of applications and possibly more personalized treatments. The standardization efforts by the EPC are a crucial step in this direction.
Conclusion
The adoption of the new general chapter on phage therapy medicinal products, the insights from in vitro studies, and the regulatory roadmap under the EU all point towards a future where phage therapy becomes a mainstream option for treating bacterial infections. With continued research and standardization, phage therapy has the potential to revolutionize the way we approach antibiotic-resistant bacteria.
