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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.