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

Publication ,  Journal Article
Berglund, JP; Szczepanski, N; Penumarti, A; Beavers, A; Kesselring, J; Orgel, K; Burnett, B; Burks, AW; Kulis, M
Published in: J Allergy Clin Immunol Pract
2017

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.

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Published In

J Allergy Clin Immunol Pract

DOI

EISSN

2213-2201

Publication Date

2017

Volume

5

Issue

4

Start / End Page

1098 / 1104

Location

United States

Related Subject Headings

  • Plant Proteins
  • Peanut Hypersensitivity
  • Membrane Proteins
  • Humans
  • Glycoproteins
  • Fungi
  • Flour
  • Desensitization, Immunologic
  • Clinical Trials as Topic
  • Bacteria
 

Citation

APA
Chicago
ICMJE
MLA
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Berglund, J. P., Szczepanski, N., Penumarti, A., Beavers, A., Kesselring, J., Orgel, K., … Kulis, M. (2017). Preparation and Analysis of Peanut Flour Used in Oral Immunotherapy Clinical Trials. J Allergy Clin Immunol Pract, 5(4), 1098–1104. https://doi.org/10.1016/j.jaip.2016.11.034
Berglund, Jelena P., Nicole Szczepanski, Anusha Penumarti, Ayeshia Beavers, Janelle Kesselring, Kelly Orgel, Bruce Burnett, A Wesley Burks, and Michael Kulis. “Preparation and Analysis of Peanut Flour Used in Oral Immunotherapy Clinical Trials.J Allergy Clin Immunol Pract 5, no. 4 (2017): 1098–1104. https://doi.org/10.1016/j.jaip.2016.11.034.
Berglund JP, Szczepanski N, Penumarti A, Beavers A, Kesselring J, Orgel K, et al. Preparation and Analysis of Peanut Flour Used in Oral Immunotherapy Clinical Trials. J Allergy Clin Immunol Pract. 2017;5(4):1098–104.
Berglund, Jelena P., et al. “Preparation and Analysis of Peanut Flour Used in Oral Immunotherapy Clinical Trials.J Allergy Clin Immunol Pract, vol. 5, no. 4, 2017, pp. 1098–104. Pubmed, doi:10.1016/j.jaip.2016.11.034.
Berglund JP, Szczepanski N, Penumarti A, Beavers A, Kesselring J, Orgel K, Burnett B, Burks AW, Kulis M. Preparation and Analysis of Peanut Flour Used in Oral Immunotherapy Clinical Trials. J Allergy Clin Immunol Pract. 2017;5(4):1098–1104.
Journal cover image

Published In

J Allergy Clin Immunol Pract

DOI

EISSN

2213-2201

Publication Date

2017

Volume

5

Issue

4

Start / End Page

1098 / 1104

Location

United States

Related Subject Headings

  • Plant Proteins
  • Peanut Hypersensitivity
  • Membrane Proteins
  • Humans
  • Glycoproteins
  • Fungi
  • Flour
  • Desensitization, Immunologic
  • Clinical Trials as Topic
  • Bacteria