Native and Engineered Mycobacteriophages: Sources, Manufacturing Technologies, and Applications in Diagnosis and Therapy of Mycobacterioses

Mycobacteriophages – viruses that infect members of the genus Mycobacterium — are emerging as a rapidly advancing platform for the diagnosis and treatment of infections caused by both tuberculous and nontuberculous mycobacteria (NTM). This review critically summarizes current approaches to (i) the discovery and isolation of native mycobacteriophages from environmental substrates; (ii) their biological and morphological characterization; (iii) molecular identification and genome annotation; (iv) targeted modification and construction of recombinant phages (including BRED) with desired properties; (v) development of pharmaceutical formulations, quality control, and biosafety; and (vi) strategies for personalized phage therapy of NTM infections, as well as the potential of reporter phages for diagnostics. Limitations (narrow host range activity, emergence of bacterial resistance, interactions with the immune system), regulatory and technological barriers, and perspectives on integrating phage platforms with antibiotic therapy and bioengineering are discussed. Standardized workflows for sampling, screening, purification, and quality control, as well as minimal research and clinical documentation sets, are proposed.