About
The UNC Food Allergy Research Manufacturing group (FARM) boasts three cGMP-compliant manufacturing suites to prevent cross-contamination between drug products. All drug doses are measured out by trained technical staff on a professional-grade balance. Protein content is calculated according to nutritional information provided by manufacturers and confirmed through protein assays. All allergens are tested for bioburden content before they are used in manufacturing of drug product and shipped to sites. Stability testing occurs at 0 months, 3 months, 6 months, 9 months, and 12 months after initial receipt of the bulk product. Our Quality Control SOPs ensure that consistent and well-controlled doses are produced and guard against any risks of mislabeling.
As a cGMP-compliant manufacturing facility, we carry out manufacturing, packaging, and shipping of drugs with adherence to cGMP guidelines. We ensure that our products meet cGMP regulations in every aspect. We have experience in writing CMC sections used in successful IND filings with the FDA. Our work on manufacturing peanut and tree nuts used in OIT trials has been published in the Journal of Allergy and Clinical Immunology: In Practice (Penumarti et al., JACI:IP 2020, Berglund et al., JACI:IP 2017).
Manufacturing Products
Depending on the study protocol we manufacture active and placebo products including but not limited to:
Oral Immunotherapy
- Peanut Flour
- Egg Powder
- Milk Powder
- Almond Flour
- Cashew Flour
- Hazelnut Flour
- Walnut Flour
- Whole Wheat Flour
- Sesame Seed Flour
- Oat Flour (Placebo)
- Tapioca Flour (Placebo)
Sublingual Immunotherapy
- Peanut extract
If you would like to discuss your projects with us, please contact us at:
Anusha Penumarti, PhD
Email: anusha23@email.unc.edu
Phone: 919-962-5482