대한민국약전 내 시험균주로 적용할 국산 미생물 5주 동등성 성능 분석

To conduct quality control assessments of sterility and microbial limit tests while reducing costs associated with drug development for domestic pharmaceutical companies, it is necessary to revise the Korean Pharmaceutical (KP) process to use domestic isolates as alternatives to ATCC strains. The National Culture Collection for Pathogens (NCCP) has distributed high-quality Korean isolates to health care fields. In this study, characteristic and equivalence tests were conducted on five species, Staphylococcus aureus NCCP 11854, Pseudomonas aeruginosa NCCP 15783, Escherichia coli NCCP 12480, Salmonella Typhimurium NCCP 16345, and Candida albicans NCCP 31538, and subjected to KP microbiological testing. Molecular and biochemical analysis by MALDI-TOF MS, VITEK-2, serological, antibiotic susceptibility, 16S rRNA sequencing, target gene sequencing, and multilocus sequence typing were performed. The equivalence between the NCCP and ATCC strains was validated by the growth promotion test and the suitability of the counting method. The strains showed more 98% genetic similarity, and equivalence results confirmed that sterility was maintained and that all reactions were conducted within the normal error range. In comparative microbial experiments, the positive and negative controls applied to the sample were compared to the ATCC strains. We expect that the five NCCP strains will be effective alternatives to KP strains. KCI Citation Count: 0