Overcoming Challenges and Regulatory Hurdles for Sustainable Bacteriophage Therapy Products

Bacteriophages are naturally occurring bacteria eaters that instantly kill a bacterial cell or integrate its genome into a bacterial chromosome. The potential use of lytic bacteriophage emerged as a new promising alternative to combat antibiotic resistance among bacterial pathogens and eliminate targeted nuisance bacteria. Therefore, it is important to understand their mode of action, application, dosage and potential side effects which is relatively complex. To maximize the potential of phage therapy, certain biological and regulatory challenges should be addressed including bacterial resistance to phage, quorum sensing, large-scale production, and receptor adaptation. In this chapter, we discuss the role of phage cocktail, phage product deployment, phage product modification, phage encapsulation to enhance shelf life of phage to allayed challenges. Also Engineered Phage with antibacterial CRISPR-Cas to allayed challenges. Safety and quality are other key concerns for prospective phage therapeutics. The production and purification process of phages requires rigorous protocols to ensure the final product contains a pure and effective cocktail. Regulators must establish guidelines and benchmarks to assess the quality, safety, and consistency ensuring to meet necessary standards for clinical settings. We also discuss here the National regulatory framework, development of Good Laboratory Practices based processes to meet international quality standards, idea of Emergency use of Investigational New Drug (IND) protocols in accordance with FDA and clinical laboratory standards for phage susceptibility testing. Information discussed in this chapter will serve as basic guidelines for addressing these challenges and bacteriophage therapy can contribute significantly to the fight against Multi-drug resistant bacterial infection, offering new hope against antibiotic resistant.