Evaluation of allergen vaccine potency.

The development of reliable and clinically relevant potency assays is essential to the practice of safe and effective allergen-specific immunotherapy. Allergen standardization in the United States is based on the establishment of a national reference assigned with a biological potency unit to which manufacturers' products are compared using validated relative potency assays. This ensures, at least with standardized allergen vaccines, comparability between lots used in clinical practice. Recent progress in the ability to measure the specific allergen content of allergen vaccines has led to its application in monitoring consistency and characterizing allergen preparations. More recently, the "major allergen" content of allergen vaccines has become a means to compare extracts from different manufacturers and to recommend immunotherapy dosing regimens. At the same time, qualitative differences exist between manufacturers' products, and most allergen vaccines used in clinical practice are nonstandardized. Therefore, this approach can be confusing and is misleading. The establishment of additional allergen reference standards and the development of reliable, accurate, and clinically relevant potency assays are urgently needed.