Genetically Modified Microorganism Safety Assessment

Genetically Modified Microorganism Safety Assessment

Genetically modified microorganisms (GMOs), whether used as production strains for industrial enzymes, food additives, or biopesticides, or as live biotherapeutic products (e.g., engineered probiotics), require multi-dimensional safety evaluation encompassing recipient strain identification, exogenous gene safety, genetic stability, and product residual detection. GeneRulor has built a systematic GMO safety assessment platform in accordance with domestic and international regulatory guidelines, including GB/T standards and FDA GRAS certification requirements. Recipient microorganism taxonomic identification integrates phenotypic characterization, genotyping (16S/ITS/gyrB molecular markers), physicochemical property determination, and average nucleotide identity (ANI) analysis, achieving strain identification precision to the species/subspecies level and establishing clear taxonomic status and safety history. Whole-genome sequencing of the recipient microorganism employs a hybrid second- and third-generation sequencing strategy to obtain high-quality complete assemblies, annotating safety-relevant elements such as virulence genes, antibiotic resistance genes, pathogenicity islands, and phage integration sites to assess the intrinsic safety of the host strain. Toxicity, anti-nutritional, and allergenicity evaluation of exogenous gene-encoded proteins utilizes bioinformatics tools to compare against known toxin databases, anti-nutritional factor libraries, and allergen databases, predicting the potential risks of exogenous proteins. GMO whole-genome sequencing (passage 1 + passage 5) evaluates exogenous gene integration stability, plasmid loss risk, and genomic mutation accumulation by comparing genome integrity across successive passages. Exogenous gene residual detection, GMO residual detection, and protein residual detection in the final product are performed by qPCR, ELISA, and related technologies to ensure the final product meets safety standards. The platform provides comprehensive technical support for GMO product regulatory submissions, GRAS certification, and market authorization.