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Bacteriophage-based veterinary products: aligning regulatory framework and development challenges for market
Céline Antoine1, David Mackay2, Paul Midtlyng3
1Laboratory of Veterinary Bacteriology, Department of Infectious and Parasitic Diseases, FARAH Research Center, Faculty of Veterinary Medicine, University of Liège, 4000, Liège, Belgium.
Summary
Bacteriophages offer a promising alternative to antibiotics in veterinary medicine due to rising antimicrobial resistance. However, regulatory and commercial hurdles must be overcome to integrate phage therapy into routine veterinary practice.
Area of Science:
- Veterinary Medicine
- Microbiology
- Biotechnology
Background:
- Antimicrobial resistance (AMR) necessitates alternative treatments in veterinary medicine.
- Bacteriophages (phages) are viruses that infect bacteria and are being reconsidered as a complementary therapy to antibiotics.
Purpose of the Study:
- To discuss the scientific, regulatory, and commercial challenges of developing and marketing phage-based products for veterinary use.
- To identify pathways for regulatory harmonization and market access for phage therapies.
Main Methods:
- The content is based on discussions from the IABS workshop "Avoiding Antimicrobial Resistance: Veterinary Use of Phages for Prevention, Therapy and Control of Bacterial Infections."
- Expert opinions and current regulatory landscapes were considered.
Main Results:
- Phage-based products face unique challenges due to their biological nature, requiring innovative product development and regulatory approaches.
- Current regulatory pathways (veterinary medicinal products, magistral preparations, food additives, biocides) are not ideally suited for phages.
- Recent guidelines offer some flexibility, but manufacturing costs and regulatory feasibility remain concerns.
Conclusions:
- Regulatory harmonization is crucial to facilitate market access for phage-based veterinary products.
- Overcoming regulatory and financial barriers is essential for integrating phage therapy into veterinary medicine for bacterial infection control.
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