Formulating and stabilising therapeutic phages: A review.

Area of Science:

• Microbiology
• Biotechnology
• Pharmaceutical Sciences

Background:

• Bacteriophages (phages) show potential as alternatives to antibiotics against resistant bacteria.
• Current limitations in phage therapy commercialization stem from poor shelf-stability of phage preparations.
• A lack of standardized formulation approaches exists due to phage diversity and varied storage methods.

Purpose of the Study:

• To review existing literature on factors influencing the shelf-stability of therapeutic phages.
• To identify knowledge gaps in phage formulation and stabilization strategies.
• To guide future research toward improving phage preparation longevity.

Main Methods:

• Literature review integrating protein and biotherapeutic formulation data.
• Examination of effects of container materials, buffers, salt/ions, pH, temperature, polymers, surfactants, and semi-solid formulations.
• Analysis of phage viability loss mechanisms.

Main Results:

• Shelf-stability is phage-dependent, influenced by various formulation and storage parameters.
• Mechanisms of viability loss include surface adsorption, colloidal instability, aggregation, and structural/functional compromise.
• Diverse factors like container type, pH, temperature, and excipients significantly impact phage stability.

Conclusions:

• Standardized formulation protocols are needed to enhance phage therapy's clinical viability.
• Further research is required to optimize phage stabilization for large-scale therapeutic use.
• Addressing formulation challenges is crucial for realizing the full potential of phage therapy.