QUALITY CONTROL OF EXPERIMENTAL BATCHES OF THE PREPARATION AGAINST ESKAPE PATHOGENS

The global increase in antibiotic resistance, particularly among pathogens of the ESKAPE group (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter cloacae), highlights the urgent need for alternative antimicrobial approaches. One promising strategy is phage therapy, which involves the use of bacteriophages capable of specifically lysing bacterial cells. The aim of this study was to evaluate the quality parameters of experimental batches of the preparation “Bacteriophage against ESKAPE pathogens,” developed at the Research Institute for Biological Safety Problems LLP, Republic of Kazakhstan. Three experimental batches of the preparation (No. 0011224, No. 0021224, No. 0031224) were examined for appearance, extractable volume, hydrogen ion concentration (pH), sterility, and specific activity against ESKAPE test cultures in accordance with SK-ESKAPE-PR-23 requirements, the State Pharmacopoeia of the Republic of Kazakhstan, and regulatory guidelines of the Eurasian Economic Union for biological medicinal products. The results demonstrated that all batches met the established quality requirements, showing stable physicochemical properties, confirmed sterility, and high specific activity maintained at dilutions up to 10⁻⁷–10⁻¹⁰. These findings confirm the stability, quality, and biological efficacy of the investigated bacteriophage preparation and support its potential for further development and application in the prevention and treatment of infections caused by antibiotic-resistant ESKAPE pathogens.

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