Objective： To trace the source of microbial contamination A1（Staphylococcus） isolated from injection sterility test in a pharmaceutical company. Methods： Illumina sequencing was used for genome-wide gene sequencing of A1 and other 16 Staphylococcus strains,which were collected from production and testing process. Unicycler software was used to splice the sequences,Prokka software was used to predict the gene of strains. The OrthoANI value and AF value between the genomic sequence and the model strains were calculated to identify the strains. The OrthoANI value in pairs was also compared. The kSNP software was used to compare SNPs in pairs,and cluster analysis was carried out by distance matrix transformation. Relevant software were used to analyze the sequence for splicing,assembling, gene prediction,gene annotation,cluster of orthologous group and single nucleotide polymorphisms respectively to get the information of the genomic size,GC content,number of editing genes,and the homology of A1 and the other collected strains. Results： Microbial contamination A1 was Staphylococcus cohnii. Its genome size was 2 765 495 bp and GC content was 32.27%. A1 was traceable to environmental bacteria A2,which was introduced during the sterility test. Conclusion： Whole-genome sequence（WGS） method is simple,rapid,stable and accurate.It is suitable for pharmaceutical companies to trace the source of contaminated strains accurately,and is conducive to realize the process control in both production and inspection process.
SUN Xue-qi, ZHANG Qin-fen, LIU Cheng-zhi, XIAO Jian, SONG An-hua
. Research of whole-genome sequence and homology analysis of microbiological contamination in injection[J]. Chinese Journal of Pharmaceutical Analysis, 2021
, 41(7)
: 1237
-1243
.
DOI: 10.16155/j.0254-1793.2021.07.15
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