Navigating Regulatory Frameworks and Compliances for Bacteriophages as Therapeutic Agents.

Abstract

The emergence of multiple antibiotic resistance in recurrent bacterial infections has led to exploring alternative therapeutic options, including using bacteria lysing viruses [bacteriophages] to control recalcitrant infections. Bacteriophages [Phage] and their end products such as enzymes, virus-like particles, and vectors are being used for varied applications such as basic and applied research for the field of phage therapeutics. Phage-based products and services such as viral vectors for gene therapy/vaccines, imaging agents, diagnostics as well as drug delivery agents form a wide range of useful innovative therapeutics that are under development. Regulatory compliances are hence essential for safely implementing phage in varied applications. Product compliances ensure safety, efficacy, stability, and quality control in preclinical as well as manufacturing and marketing processes. A well-established regulatory framework ensures innovative product development with high rates of successful clinical translation and development of phage therapeutics as effective alternatives to antibiotics or for consideration in integrated pathogen management strategies. This review highlights the importance of regulatory standards in different stages of phage therapy- during preclinical research as well as different regulatory bodies in the manufacturing, clinical evaluation, and market approval of phage-based products. Global trends in facilitating phage therapeutics' regulatory frameworks and compliances are discussed.