Bacteriophage-Based Therapeutic, Diagnostic, and Biocontrol Platforms: Engineering, Evidence, and Translational...

Area of Science:

• Microbiology
• Biotechnology
• Bioengineering

Background:

• Bacteriophages are viruses that infect bacteria and are being explored for various applications.
• Their utility is highly dependent on the specific context of use, whether therapeutic, diagnostic, or for biocontrol.
• Existing research highlights the need for application-specific evaluation of phage capabilities.

Purpose of the Study:

• To review the biological and engineering principles underlying phage-based platforms.
• To evaluate the efficacy of therapeutic, diagnostic, and non-clinical phage applications using an evidence framework.
• To emphasize the necessity of tailored validation strategies for phage technologies.

Main Methods:

• Literature review focusing on biological and engineering principles of bacteriophages.
• Application-specific evidence framework for evaluating therapeutic, diagnostic, and biocontrol uses.
• Analysis of key performance indicators relevant to each application, including in vitro and in vivo efficacy, resistance, and ecological impact.

Main Results:

• Therapeutic phages require in vivo efficacy, persistence, and resistance management, not just in vitro lysis.
• Diagnostic phages need high sensitivity, specificity, and matrix tolerance.
• Non-clinical applications (food, agriculture, environment) depend on formulation stability, host specificity, and ecological safety.
• Recent findings emphasize the importance of phage dissemination, plaque expansion, and resistance-bypass phenotypes for therapeutic candidates.

Conclusions:

• Phage technologies are versatile but require context-specific validation frameworks.
• Strategies like phage cocktails and engineered phages are adaptive, not universal solutions.
• Linking biological function, manufacturing quality, regulatory feasibility, and meaningful endpoints is crucial for successful phage platform development.