Safety Evaluation of Serendipity Berry Sweet Protein From Komagataella phaffii.

Abstract

Serendipity Berry Sweet Protein (sweelin) is a novel hyper-sweet thermophilic protein designed using Artificial Intelligence Computational Protein Design (AI-CPD) to improve the stability and sensory profile of the protein found in serendipity berry (Dioscoreophyllum cumminsii). sweelin is produced through precision fermentation by expression in Komagataella phaffii. The safety of sweelin was investigated through an evaluation of its genotoxicity, mutagenicity, systemic toxicity and digestibility potential in in vitro and in vivo models. sweelin was not genotoxic in in vitro reverse mutation and mammalian micronucleus assays and was not associated with systemic toxicity in a 90-day dietary toxicity study in rats. The no-observed-adverse-effect level for sweelin in Sprague Dawley rats was established as 14,300 ppm, the highest dose tested. This dose level corresponds to dietary intakes of 838.3 and 946.0 mg/kg body weight/day in male and female rats, respectively. sweelin was demonstrated to be readily digestible in an in vitro semi-dynamic model of the gastrointestinal tract. The results support the safety of sweelin as a food ingredient for sweetening purposes.