Allergen Standardisation in Allergens and Allergoids – Challenges and Considerations

Background: The range of therapeutics and dosing schedules for allergen preparations and allergoids produced and used clinically are considerable. Standardisation of allergy immunotherapies is considered a positive step; however there are difficulties in identifying universal metrics for standardisation.  Many advocate the use of major allergen content whilst others advocate total allergenicity.  Additionally as a compounding argument, where major allergen is used, many disagree on what the major allergen is for certain species.

Methods: Major allergen content measurement allows a consistent recognised measure, and IgE responses of a serum pool are often dominated by IgE against major allergens. However issues such as specificity of different assays toward isoforms and other variants of single allergens often results in diverging allergen contents that can cause unexpected and misleading disparity. Other aspects that increase complication are the relevance to modified allergens, use of adjuvants and differing dosing regimes.

Results: The major allergen content of key products in different therapeutic formats have been measured. 

Conclusions: This has been performed in conjunction with techniques such as total allergenicity, as allergy treatments and therapeutics require careful characterisation to allow supply of consistent, safe and efficacious products.