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First Patient in UMC Utrecht Treated with Experimental Virus Therapy

  1. 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

  1. 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

  1. 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

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.

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