Preparation and Analysis of Peanut Flour Used in Oral Immunotherapy Clinical Trials

Abstract

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.

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