ABSTRACT
This chapter reviews the manufacturing procedures for food allergen extracts. The chapter also reviews applicable regulatory requirements, potential approaches to standardization, and clinical application of these products. Food allergen extracts are complex biological products used for the diagnosis, but not treatment, of food allergy. Preparation of a food allergen extract requires careful selection and identification of source materials, grinding, defatting, extraction conditions, clarification, sterilization, and product testing. Variation in any of these steps can affect the quality of the final product. Although extractions for all products licensed for use in the United States are performed using raw source materials, many foods are not consumed in their raw form. Thermal and nonthermal processing alters the allergenicity of many common food allergens. Processing prior to extraction may therefore change the allergenicity of the final product. The manufacture of food allergen extracts is a complex process with many considerations to maximize the 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.
