Exponent : Comprehensive Safety Assessment of a Precision Fermentation Ingredient
May 10, 2024 at 09:26 pm EDT
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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.
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09 May 2024 and is solely responsible for the information contained therein. Distributed by
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Exponent, Inc., together with its subsidiaries, is a science and engineering consulting firm. The Company serves clients in chemicals, construction, consumer products, energy, food, beverage and nutrition, government, life sciences, insurance, manufacturing, technology, industrial equipment, transportation, and other sectors. It provides engineering and scientific consulting services to clients around the world. Its service offerings are provided on a project- by-project basis. The Company has two segments: Engineering and Other Scientific, and Environmental and Health. The Engineering and Other Scientific segment is a service group providing technical consulting in different practices, primarily in engineering. The Environmental and Health segment provides services in the area of environmental, epidemiology and health risk analysis. This segment provides a range of consulting services relating to environmental hazards and risks and the impact on both human health and the environment.
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