Allergen extracts are biological products used to diagnose and treat allergic diseases. Knowledge about how allergen extracts are made is critical for the clinician for the purpose of selecting appropriate extracts for diagnosis and allergen specific immunotherapy.
Various steps are involved in the production of allergen extracts. These steps include, but are not limited to, the proper selection and procurement of allergenic raw materials, the manufacturing processes utilized, the quality procedures in place to assure that the extracts have a consistent allergen composition and potency, and the measures used to support particular expiration dates.
The allergens utilized to produce extracts generally can be classified as natural or recombinant. Natural allergens have been used for many years and will continue to be used for the time to come because of the varying limitations regarding the production and use of recombinant allergens.
Most catalogs of allergen extracts list pollen, mites, fungi (“molds”), insects, epithelia (mammalian allergens), hymenoptera venoms, foods, and “others”. Therefore, the procurement of the raw materials to produce those allergen extracts varies, depending on the product. Natural allergenic raw materials are diverse in origin and have different characteristics. They are obtained from the outdoor environment (i.e. pollen), from laboratory cultures (i.e mites and fungi), animal groomers (i.e. epithelia), and supermarkets (foods).
A series of articles, entitled “How Allergen Extracts Are Made – From Raw Materials to Final Extracts”, which address each type of product individually, has been prepared to inform the clinician and other interested professionals about the topic. The individual articles of the series have been published monthly in the Annals of Allergy and Immunology during 2017, and are included below.