Allergenicity, Genotoxicity and Subchronic Toxicity Assessment of IgG Binding Protein LT Produced From Aspergillus oryzae

Gastrointestinal health is one of the fastest growing areas in the food and beverage industry, as its importance to overall health and well-being is becoming increasingly recognized. Immunoglobulins play a key role in protecting the gastrointestinal tract, and nonbovine sources of immunoglobulins (including camel milk, which has a long history of consumption in East Africa and Asia) are increasing in popularity in Western countries as functional foods, particularly for individuals with allergies or intolerances to cow's milk. The physiological benefits of consuming certain heavy-chain immunoglobulins from camel milk relate to the binding domains of camelid single-domain antibodies; thus, a novel binding protein termed "immunoglobulin G (IgG) binding protein LT" (a dimer of two camelid single-domain antibody protein sequences) has been developed for use in food and beverage products, to provide some of the physiological benefits attributed to consuming camel milk, on an industrial scale. To support the safety of IgG binding protein LT for such use, a comprehensive safety assessment (in silico allergenicity assessment, in vitro genotoxicity studies [bacterial reverse mutation test and in vitro mammalian cell micronucleus test], and a 90-day gavage toxicity study in rats) was conducted. The in silico allergenicity assessment results demonstrate that IgG binding protein LT is highly unlikely to pose a risk of allergenic cross-reactivity, and there was no evidence of genotoxicity in vitro. There were no test article-related effects in the 90-day toxicity study. These data demonstrate the safety of IgG binding protein LT for its intended uses in foods and beverages.