Major Allergen Characterization
The active ingredients of allergenic extracts are the proteins that the immune system responds to. Within an extract, there may be multiple allergenic proteins. Major allergens are those proteins to which at least 50% of a population are sensitized to. Some of these allergens, such as Fel d 1 in cat, are well established and are used as the basis for standardization.
From the extensive research ALK has performed in its European laboratories, ALK scientists have access to a library of internally validated major allergen assays. With these methods, ALK can monitor the potency and consistency of its extracts between lots based on measures of these important proteins. This is especially useful with products that have not yet been standardized and so far lack FDA-defined methods for potency monitoring. Many non-standardized extracts have well known allergens that can be measured and characterized, such as Bet v 1 in Birch pollen.
ALK’s post manufacturing work on major allergen testing provides information for two important purposes:
- Internal monitoring of extract quality
- Comparing therapeutic doses in the literature, which are based primarily on major allergen measures used in European clinical trials. These measures were the basis for current standardized dosing recommendations.
For more information on how major allergen concentration affects dosing, please see the section on Dosing.