title: 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 Food and Drug Administration-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 Escherichia coli, salmonella, yeast, mold, and total aerobic bacteria. In addition, aflatoxin was quantified in peanut flour. Reported results were obtained from 4 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 these parameters remain stable over a 12-month period.
authors.affiliation: Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC.
authors.forename: Jelena P
authors.initials: JP
authors.lastname: Berglund
authors.affiliation: Department of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Nicole
authors.initials: N
authors.lastname: Szczepanski
authors.affiliation: Department of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Anusha
authors.initials: A
authors.lastname: Penumarti
authors.affiliation: Department of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Ayeshia
authors.initials: A
authors.lastname: Beavers
authors.affiliation: Department of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Janelle
authors.initials: J
authors.lastname: Kesselring
authors.affiliation: Department of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Kelly
authors.initials: K
authors.lastname: Orgel
authors.affiliation: Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC.
authors.forename: Bruce
authors.initials: B
authors.lastname: Burnett
authors.affiliation: Department of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: A Wesley
authors.initials: AW
authors.lastname: Burks
authors.affiliation: Department of Pediatrics, Division of Allergy, Immunology, and Rheumatology, University of North Carolina at Chapel Hill, Chapel Hill, NC. Electronic address: mike.kulis@unc.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: Kulis
mesh_terms: D055516:2S Albumins, Plant / Q000032:analysis; D000348:Aflatoxins / Q000032:analysis; D000485:Allergens / Q000032:analysis; D052179:Antigens, Plant / Q000032:analysis; D010367:Arachis; D001419:Bacteria / Q000302:isolation & purification; D002986:Clinical Trials as Topic; D003888:Desensitization, Immunologic; D005433:Flour / Q000032:analysis* / Q000382:microbiology; D005658:Fungi / Q000302:isolation & purification; D006023:Glycoproteins / Q000032:analysis; D006801:Humans; D008565:Membrane Proteins; D021183:Peanut Hypersensitivity / Q000628:therapy; D010940:Plant Proteins / Q000032:analysis
chemical_list: D055516:2S Albumins, Plant; D000348:Aflatoxins; D000485:Allergens; D052179:Antigens, Plant; C500889:Ara h 1 protein, Arachis hypogaea; C078642:Ara h II protein, Arachis hypogaea; D006023:Glycoproteins; D008565:Membrane Proteins; D010940:Plant Proteins
keywords: Ara h 1; Ara h 2; Drug product; Microbial testing; Peanut allergy; Peanut flour; Peanut oral immunotherapy; Stability testing