A framework for biosafety assessment of microbial strains in Biotechnology applications.

Abstract

Biosafety refers to the principles and practices that prevent unintentional exposure to biological agents and limit their potential harm to humans and the environment. Therefore, we developed a comprehensive biosafety assessment framework for 40 microbial strains used in biotechnology, evaluating five key parameters: pathogenicity, immunogenicity, environmental persistence, genetic stability, and taxonomy. Principal component analysis showed that 84% of the risk variation was unrelated to taxonomy, emphasizing the need for strain-specific evaluations. Among the strains assessed, 76% of fungi triggered high levels of TNF-α and IL-6 in immune cell assays, and 68% persisted beyond 30 days in simulated environmental conditions. Meanwhile, 71% of gram-negative bacteria carried virulence genes (et al., hlyA, invA) and exhibited significant cytotoxicity in human cell cultures. These findings support a data-driven, parameter-based approach for advancing biosafety standards in modern biotechnology.