Objectionable organisms remain a major threat to pharmaceutical product safety, and among them, human bacterial pathogens stand out for their potential to impact not only product integrity and safety but also manufacturing continuity. Contamination can mean delayed releases, facility shutdowns, and steep financial and reputational costs. In a 5-year global review of over 764,040 EM isolates from 3,300+ sites, more than 800 of the 1,460 known human bacterial pathogens (Bartlett et al., Microbiology 2022;168:001269) were confirmed by DNA sequencing. These findings underscore the frequency - and risk - posed by potentially pathogenic species in manufacturing environments.Curated complementary information such as Risk Group and physiological attributes provide microbiologists with immediate access to essential information for risk assessments. However, such information does not always provide a comprehensive evaluation for assessing pathogenicity. Whole genome sequencing can provide deeper insights into the organism of concern when further characterization is required, especially when screened for genes relevant to preservative resistance, cold sensitivity, pathogenicity, or antimicrobial/disinfectant resistance. This additional testing can improve the quality of risk assessments. This approach enhances environmental control and supports better protection for both products and people.
Khot et al. (Thu,) studied this question.