Evaluation of the potential food allergy risks of human lactoferrin expressed in Komagataella phaffii

• DOI: 10.3389/fimmu.2024.1380028
• Publication Date: 2024-07-24T05:14:36Z
• Authors: Yanisa Anaya; Raysa Rosario Mar...; Richard E. Goodman; Philip Johnson; Shashwat Vajpeyi; Xiaoning Lu; Ross Peterson; Sarah M. Weyers; Bella Breen; Kahler Newsham; Brian Scottoline; Anthony J. Clark; Carrie-Anne Malin...
• Keywords: Lactoferrin; Pepsin

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