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

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. The allergenic risk potential of Helaina recombinant human lactoferrin (rhLF, Effera™), produced in ( )...

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Bibliographic Details
Published in:	Frontiers in immunology Vol. 15; p. 1380028
Main Authors:	Anaya, Yanisa, Rosario Martinez, Raysa, Goodman, Richard E, Johnson, Philip, Vajpeyi, Shashwat, Lu, Xiaoning, Peterson, Ross, Weyers, Sarah M, Breen, Bella, Newsham, Kahler, Scottoline, Brian, Clark, Anthony J, Malinczak, Carrie-Anne
Format:	Journal Article
Language:	English
Published:	Switzerland Frontiers Media S.A 24-07-2024
Subjects:	allergenicity Allergens - immunology codex Computational Biology - methods Food Hypersensitivity - immunology human lactoferrin Humans Immunology Komagataella phaffii Lactoferrin - immunology Pichia pastoris recombinant protein Recombinant Proteins - immunology Risk Assessment Saccharomycetales - immunology Saccharomycetales - metabolism Komagataella phaffii human lactoferrin recombinant protein glycosylation Pichia pastoris codex allergenicity
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Summary:	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. The allergenic risk potential of Helaina recombinant human lactoferrin (rhLF, Effera™), produced in ( ) was assessed by literature search, bioinformatics sequence comparisons to known allergens, glycan allergenicity assessment, and a simulated pepsin digestion model. The literature search identified no allergenic risk for Helaina rhLF, , 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. 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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Reviewed by: Darren Nicholas Nesbeth, University College London, United Kingdom Edited by: Weicheng Hu, Yangzhou University, China Gisele Monteiro, University of São Paulo, Brazil Brian Effer Roldan, University of La Frontera, Chile
ISSN:	1664-3224 1664-3224
DOI:	10.3389/fimmu.2024.1380028