Innovative Test Enhances Quality Control in Allergy Treatments

A multidisciplinary team from the Allergology and Veterinary Medicine Divisions at the Paul Ehrlich Institute has developed a groundbreaking laboratory assay that allows for the precise quantification of adjuvanted allergoids within finished allergy medicinal products. Previously, assessing the content of these complex formulations was challenging due to their intricate structures, which contain both allergen-modifying compounds (allergoids) and adjuvants, restricting analysis to intermediary production stages. The newly introduced testing method marks a significant breakthrough in the quality assurance of allergy immunotherapy (AIT) medications.

Allergy immunotherapy involves using sensitized allergens to train the immune system towards tolerance, with allergoids being chemically modified allergens designed for this purpose. Accurate dosing and proven efficacy depend heavily on knowing the exact allergoid concentration, yet until now, this measurement in final pharmaceutical formulations was not feasible. The novel immunoassay employs highly specific antibodies in an enzyme-linked detection system, enabling accurate, reliable detection of allergoids directly in medicinal products. This method can effectively eliminate the need for animal testing and enhances the standardization and quality control processes.

The research, published in the journal "Allergy," demonstrates that this assay can consistently measure allergen content in grass pollen allergoids, which are common components in allergy therapy. The project was led by Dr. Frank Führer from the Paul Ehrlich Institute, emphasizing the importance of this advancement for regulatory oversight and manufacturing quality assurance. The implementation of such precise testing protocols promises to improve the consistency, safety, and efficacy of allergy treatments, benefiting both manufacturers and patients.

This development reinforces the Paul Ehrlich Institute's role in ensuring the safety and quality of allergy immunotherapies, responding to regulatory requirements by providing a sophisticated tool for batch testing and standardization. Source: https://medicalxpress.com/news/2025-06-quality-allergy-therapeutics.html