ABSTRACT
Pollen and fungal raw materials are utilized to produce allergen extracts for diagnosis and treatment of allergies in most areas of the world. Because these materials are natural products, they are subjected to large qualitative and quantitative variations of their allergenic characteristics, which are addressed during manufacturing. For example, because pollen is collected from the outdoors, environmental contaminants may impact this product before and during collection. The fungi utilized to produce raw materials are derived from particular strains grown in a laboratory. The culture medium and growth conditions are relevant parameters partially responsible for the allergenic properties of the fungal raw materials. While manufacturers of allergen extracts use different raw materials and manufacturing techniques, they follow analogous steps to produce allergen extracts. Another consideration is associated with the diverse regulations in place in different areas of the world. Harmonization is needed to produce consistent pollen and fungal allergen extracts. This chapter provides an overview of the steps involved in obtaining pollen and fungal raw materials and in manufacturing the associated allergen extracts. A brief comparison between the general regulations in place in the United States and Europe is also provided. This information will assist the clinician to properly select the best allergen extracts commercially available.
