Table_1_Evaluation of the potential food allergy risks of human lactoferrin expressed in Komagataella phaffii.xlsx

IntroductionPrior to the introduction of novel food ingredients into the food supply, safety risk assessments are required, and numerous prediction models have been developed and validated to evaluate safety.
MethodsThe allergenic risk potential of Helaina recombinant human lactoferrin (rhLF, Effera™), produced in Komagataella phaffii (K. phaffii) was assessed by literature search, bioinformatics sequence comparisons to known allergens, glycan allergenicity assessment, and a simulated pepsin digestion model.
ResultsThe literature search identified no allergenic risk for Helaina rhLF, K. phaffii, or its glycans. Bioinformatics search strategies showed no significant risk for cross-reactivity or allergenicity between rhLF or the 36 residual host proteins and known human allergens. Helaina rhLF was also rapidly digested in simulated gastric fluid and its digestibility profile was comparable to human milk lactoferrin (hmLF), further demonstrating a low allergenic risk and similarity to the hmLF protein.
ConclusionCollectively, these results demonstrate a low allergenic risk potential of Helaina rhLF and do not indicate the need for further clinical testing or serum IgE binding to evaluate Helaina rhLF for risk of food allergy prior to introduction into the food supply.

引言：在新型食品成分纳入食品供应链之前，需开展安全性风险评估，目前已开发并验证了多种用于评估食品安全性的预测模型。

方法：通过文献检索、与已知过敏原的生物信息学序列比对、聚糖致敏性评估以及模拟胃蛋白酶消化模型，对在巴斯德毕赤酵母（Komagataella phaffii）中表达的海莱娜重组人乳铁蛋白（Helaina recombinant human lactoferrin，rhLF, Effera™）的致敏风险潜力进行了评估。

结果：文献检索未发现海莱娜重组人乳铁蛋白、巴斯德毕赤酵母及其聚糖存在致敏风险。生物信息学检索策略显示，重组人乳铁蛋白或36种残留宿主蛋白与已知人类过敏原之间不存在交叉反应性或致敏性的显著风险。海莱娜重组人乳铁蛋白在模拟胃液中可被快速消化，其消化特性与人乳乳铁蛋白（human milk lactoferrin, hmLF）相当，进一步证实其致敏风险较低且与人乳乳铁蛋白具有相似性。

结论：综上，上述结果表明海莱娜重组人乳铁蛋白具有较低的致敏风险潜力，无需开展进一步的临床试验或血清IgE结合试验以评估其在纳入食品供应链前的食物过敏风险。