title: Stability of a set of allergens and non-allergens in simulated gastric fluid.
abstract: Stability in simulated gastric fluid has been suggested as a parameter for consideration in the allergenicity assessment of transgenic proteins. However, the relationship between the stability of proteins in simulated gastric fluid and allergenicity has been inconsistent among studies conducted with reference allergens and non-allergens. Differences in laboratory methods and data interpretation have been implicated as possible causes for conflicting study results. We attempted to mitigate some of the methodological inconsistencies among laboratory methods by applying a kinetic interpretation to results of digestion experiments conducted with a set of known allergens and putative non-allergens. We found that pepsinolysis in simulated gastric fluid generally followed an exponential (pseudo-first-order) pattern of decay, at least during the terminal (slower) phase of digestion, allowing the calculation of digestion half-lives. While digestibility estimates were reproducible and robust, results for the proteins evaluated in this study did not support a significant association between stability in simulated gastric fluid and allergenicity.
authors.affiliation: Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268, USA. raherman@dow.com
authors.forename: Rod A
authors.initials: RA
authors.lastname: Herman
authors.forename: Michael M
authors.initials: MM
authors.lastname: Woolhiser
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Ladics
authors.forename: Valerie A
authors.initials: VA
authors.lastname: Korjagin
authors.forename: Barry W
authors.initials: BW
authors.lastname: Schafer
authors.forename: Nicholas P
authors.initials: NP
authors.lastname: Storer
authors.forename: Susan B
authors.initials: SB
authors.lastname: Green
authors.forename: Lynn
authors.initials: L
authors.lastname: Kan
mesh_terms: D000485:Allergens / Q000378:metabolism*; D004044:Dietary Proteins / Q000276:immunology / Q000378:metabolism*; D004063:Digestion / Q000502:physiology; D004591:Electrophoresis, Polyacrylamide Gel / Q000379:methods; D005750:Gastric Juice / Q000276:immunology* / Q000378:metabolism; D006207:Half-Life; D006801:Humans
chemical_list: D000485:Allergens; D004044:Dietary Proteins