PDF(Pubmed)
Abstract：
UNASSIGNED: Prior 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.
UNASSIGNED: The 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.
UNASSIGNED: The 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.
UNASSIGNED: Collectively, 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.
UNASSIGNED: The 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.
UNASSIGNED: The 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.
UNASSIGNED: Collectively, 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.
摘要：
■在将新的食品配料引入食品供应之前，需要进行安全风险评估，并且已经开发和验证了许多预测模型来评估安全性。
■Helaina重组人乳铁蛋白（rhLF，Effera™),在Komagataellaphafii(K.phafii)通过文献检索进行评估，与已知过敏原的生物信息学序列比较，聚糖变应原性评估，和模拟胃蛋白酶消化模型。
■文献检索发现HelainarhLF没有过敏风险，K.phafii,或其聚糖。生物信息学搜索策略显示rhLF或36种残留宿主蛋白与已知人类变应原之间的交叉反应性或变应原性没有显著风险。HelainarhLF在模拟胃液中也被快速消化，其消化率与人乳乳铁蛋白（hmLF）相当，进一步证明了低过敏风险和与hmLF蛋白的相似性。
■集体，这些结果证明HelainarhLF的潜在致敏风险较低,并且不表明在将HelainarhLF引入食品供应之前,需要进一步的临床检测或血清IgE结合来评估HelainarhLF的食物过敏风险.
■Helaina重组人乳铁蛋白（rhLF，Effera™),在Komagataellaphafii(K.phafii)通过文献检索进行评估，与已知过敏原的生物信息学序列比较，聚糖变应原性评估，和模拟胃蛋白酶消化模型。
■文献检索发现HelainarhLF没有过敏风险，K.phafii,或其聚糖。生物信息学搜索策略显示rhLF或36种残留宿主蛋白与已知人类变应原之间的交叉反应性或变应原性没有显著风险。HelainarhLF在模拟胃液中也被快速消化，其消化率与人乳乳铁蛋白（hmLF）相当，进一步证明了低过敏风险和与hmLF蛋白的相似性。
■集体，这些结果证明HelainarhLF的潜在致敏风险较低,并且不表明在将HelainarhLF引入食品供应之前,需要进一步的临床检测或血清IgE结合来评估HelainarhLF的食物过敏风险.
