Standardization and Regulation of Allergen Products in the European Union

Abstract

Product-specific standardization is of prime importance to ensure persistent quality, safety, and efficacy of allergen products. The regulatory framework in the EU has induced great advancements in the field in the last years although national implementation still remains heterogeneous. Scores of methods for quantification of individual allergen molecules are developed each year and also the challenging characterization of chemically modified allergen products is progressing. However, despite the unquestionable increase in knowledge and the subsequent improvements in control of quality parameters of allergen products, an important aim has not been reached yet, namely cross-product comparability. Still, comparison of allergen product potency, either based on total allergenic activity or individual allergen molecule content, is not possible due to a lack of standard reference preparations in conjunction with validated standard methods. This review aims at presenting the most recent developments in product-specific standardization as well as activities to facilitate cross-product comparability in the EU.

Minor allergen patterns in birch pollen allergen products—A question of pollen?

“…Although some observations imply a link between more severe allergy symptoms and sensitization to minor allergens, their relevance for safety and efficacy of allergen products is virtually unknown and data from controlled clinical trials are lacking. While standardization of allergen product manufacturing and composition has generally advanced in the past decade, neither raw materials nor production processes or storage conditions are standardized with regard to minor allergens . If at all, methods for minor allergen quantification are developed in scientific contexts and are not commercially available.…”

Indoor Allergens and Allergic Respiratory Disease

“…Commercial allergen extracts are standardized based on in-house assays and standards and are not comparable between different manufacturers [99]. Efforts to improve standardization and enable cross-product comparisons using individual recombinant allergens were initiated in 2001 with the CREATE project of the European Union [100].…”

Evaluation of the manufacturer-dependent differences in specific immunoglobulin E results for indoor allergens

“…In the European Union, many extracts are mainly standardized by in-house assays based on their allergenic potency. 18 This would most likely account for the large differences between the collectives, for no one knows the "correct" values.…”