Background
Oral immunotherapy (OIT) is an investigational therapeutic approach for the treatment of food allergies. Characterization of the drug product used in oral immunotherapy trials for peanut allergy has not been reported.
Objective
To quantify relative amounts of the major peanut allergens and microbial load present in peanut flour used in OIT trials and assess whether these parameters change over a 12 month period. We also anticipate that this report will serve as a guide for investigators seeking to conduct OIT trials under FDA-approved Investigational New Drug applications.
Methods
Densitometric scanning of Ara h 1 and Ara h 2 resolved on SDS-PAGE gels was used to assess allergen content in peanut flour extracts. Microbial testing was conducted on peanut flour under US Pharmacopeia guidelines for the presence of E. coli, Salmonella, yeast, mold, and total aerobic bacteria. Additionally, aflatoxin was quantified in peanut flour. Reported results were obtained from four unique lots of peanut flour.
Results
Relative amounts of the major peanut allergens were similar between different lots of peanut flour and remained stable over a 12 month period. E. coli and Salmonella were absent from all lots of flour. Yeast, mold, total aerobic bacteria, and aflatoxin were within established US Pharmacopeia guidelines on all lots tested and remained within the criteria over a 12 month period.
Conclusions
Peanut flour used as a drug product contains the major peanut allergens and has low levels of potentially harmful microbes. Both of these parameters remain stable over a 12 month period.
The manufacture of food allergen extracts requires many considerations to achieve the maximal quality of the final product. Allergen extracts for a select number of foods may be inconsistent between manufacturers or unreliable in a clinical setting, indicating a potential area for future improvement.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.