Comprehensive Safety Assessment of a Precision Fermentation Ingredient

Spermidine is a polyamine essential for the growth and function of normal cells. Precision fermentation techniques enable the reproducible production of highly concentrated, pure compounds such as spermidine, which may be difficult to obtain from natural sources. Appropriately designed and conducted safety studies are often a critical component in bringing these ingredients to market.

Exponent's Paola Chrysostomou, Elaine Freeman, and Mary Murphy and their coauthors designed and conducted multiple toxicological assessments to evaluate the safety of spermidine-3HCl, a highly pure substance produced from a genetically engineered strain of Saccharomyces cerevisiae through a precision fermentation process coupled with an innovative purification methodology. 

The Exponent team worked with the study sponsor and the lab to design guideline compliant toxicology studies to assess the safety of the precision fermentation substance. They published their findings in an article titled "A toxicological assessment of spermidine trihydrochloride produced using an engineered strain of Saccharomyces cerevisiae" in Food and Chemical Toxicology.

The in vitro and in vivo studies demonstrated that spermidine-3HCl produced using an engineered strain of S. cerevisiae was non-genotoxic and caused no adverse effects up to and including the highest concentration tested in subchronic repeated dose toxicity studies by dietary administration. The findings from this study can be used to support the safety of a novel ingredient made through precision fermentation.

From the publication: "Spermidine trihydrochloride (spermidine-3HCl) of high purity can be produced using an engineered strain of Saccharomyces cerevisiae. Spermidine has a demonstrated history of safe use in the diet; however, limited information is available in the public literature to assess the potential toxicity of spermidine-3HCl."