Allergenicity Assessment of a Genetically Modified Protein-Recombinant Human Lactoferrin

Zhou, Chuanpeng; Sun, Ninghui

doi:10.4172/2155-6121.s3-002

Cited by 5 publications

(7 citation statements)

References 53 publications

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“…34 Considering the rapid digestion by pepsin and no specific binding of IgE using serum from patients with milk and egg allergy, the authors concluded the allergenicity potential of this self-protein is very low. 34 A single paper that suggested a possible risk from human lactoferrin was for protein expressed in rice that has cross-reactive carbohydrate determinants (CCD) on asparagine-linked glycosylation sites which may be linked to allergy. 42 Importantly, the rice-expressed protein did not elicit basophil activity due to IgE binding to CCD and there was no proof of allergy to that product.…”

Section: Resultsmentioning

confidence: 99%

“…42 In the case of α-gal, which can occur in mammalian hosts, studies have shown this allergenic glycan in bovine milk, γ-globulin, lactoferrin, and lactoperoxidase. 53 In the study evaluating rhLF produced in transgenic cows 34 which would likely contain α-gal, no increased allergenic risk was observed, including no specific IgE binding in serum. Helaina-evaluated glycans detect neither CCD nor α-gal and contain only N-linked glycans that are oligomannose.…”

Section: Discussionmentioning

confidence: 99%

“…53 The other suggested cross-reactive allergen based on bioinformatics searches is ovo-transferrin, or Gal d 3, a major allergen naturally found in egg-white that binds IgE. 54,55 Importantly, a study by Zhou, et al evaluated potential serum IgE binding between human LF (rhLF from transgenic cows or hLF) or bovine LF and sera from individuals allergic to milk or egg and found no visible cross-reactivity of rhLF, hLF, or bLF to the test serum samples 34 . The paper that suggested a possible risk from human lactoferrin was for protein expressed in rice that has cross-reactive carbohydrate determinants on some asparagine-linked glycosylation sites.…”

Section: Discussionmentioning

confidence: 99%

“…Codex guidelines have been applied to evaluate the potential allergenicity of other novel proteins expressed in a recombinant host and residual host proteins that remain in food fractions, such as rhLF produced in transgenic cows 34 and soybean leghemoglobin. 35 However, the guidelines have yet to be applied to rhLF expressed in K. phaffii ; therefore, the main objective of this work was to apply Codex criteria to evaluate the potential allergenic risk of Helaina rhLF.…”

Section: Introductionmentioning

confidence: 99%

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Evaluation of the potential food allergy risks of recombinant human lactoferrin expressed inKomagataella phaffii

Anaya,

Rosario Martinez,

Goodman

et al. 2024

Preprint

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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 inKomagataella phaffii(K. phaffii) 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,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. 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.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Evaluation of the potential food allergy risks of recombinant human lactoferrin expressed inKomagataella phaffii

Anaya,

Rosario Martinez,

Goodman

et al. 2024

Preprint

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“…Côte d'Ivoire, Burundi and Angola). Sensitization to egg in South American children ranges greatly, from 5 to 30% [21]. Published evidence on administration of the YFV in this group of patients is surprisingly limited.…”

Section: Discussionmentioning

confidence: 99%

Administration of Yellow Fever Vaccine in Patients with Egg Allergy

Rutkowski

Ewan

Nasser

2013

Int Arch Allergy Immunol

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Background: The population of large parts of Africa, South America and travellers to these areas are at risk of yellow fever (YF) with a 50% mortality risk. Yellow fever vaccine (YFV) propagated in hens' eggs confers protection in 95% of the vaccinated. The rate of anaphylaxis for YFV ranges from 0.42 to 1.8/100,000 doses with most cases considered to be due to egg allergy. Egg allergy is a contraindication for the YFV. Nevertheless, the potential fatal sequelae from YF give the incentive to protect everyone at risk irrespective of their allergic status. Methods: Six subjects who had had a recent reaction to egg and who were travelling to endemic areas (3 adults and 3 children) underwent skin prick tests (SPT) with undiluted YFV and egg extract. Intradermal tests for YFV were undertaken at a 1:10 dilution. In 4 egg-allergic patients with a positive SPT to YFV, a 7-step desensitization protocol was used. A 2-step (10 + 90%) protocol was used in the 2 subjects with a negative YFV SPT. Premedication was not administered. Results: All 6 patients were successfully vaccinated. Four patients completed desensitization: 1 developed mild local erythema at the injection site, 1 had fleeting generalized urticaria with local erythema/angioedema and 2 did not experience any adverse reactions. Patients who received YFV in 2 steps developed no adverse reactions. Conclusions: We describe the successful administration of YFV in 6 egg-allergic patients. The Cambridge Allergy 7-step protocol allows for its safe administration in patients with positive SPT to YFV. A 2-step protocol can be used in patients with negative YFV SPT.

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Overviews of Food Allergy and Evaluating Methods Used in Allergenic Assessment of GMOs with Application Examples Conducted in Our Laboratory

Huang

2017

Safety Assessment of Genetically Modified Foods

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Allergenicity Assessment of a Genetically Modified Protein-Recombinant Human Lactoferrin

Cited by 5 publications

References 53 publications

Evaluation of the potential food allergy risks of recombinant human lactoferrin expressed inKomagataella phaffii

Evaluation of the potential food allergy risks of recombinant human lactoferrin expressed inKomagataella phaffii

Administration of Yellow Fever Vaccine in Patients with Egg Allergy

Overviews of Food Allergy and Evaluating Methods Used in Allergenic Assessment of GMOs with Application Examples Conducted in Our Laboratory

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