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Regulatory Research: New Test Improves Quality Control of Allergy Therapeutics
An interdisciplinary research team from the Allergology and Veterinary Medicine Divisions at the Paul-Ehrlich-Institut (PEI) has developed a novel laboratory test that enables the determination of adjuvanted allergoids in finished medicinal products. Content analyses of finished medicinal products were not possible in the past due to the complex structure of this medicinal product group, which contains both adjuvants and allergoids (chemically modified allergens) and therefore had to be performed on an intermediary production step. The new test method represents significant progress in the quality control of medicines for allergy therapy. The journal Allergy reports on the results.
Jun 6, 2025, 5:19:22 PM
Dr. Susanne Stöcker
, Paul-Ehrlich-Institut - Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
Allergen immunotherapy (AIT) is used to treat allergies. Allergoids are chemically modified allergens that are used in specific immunotherapy to modulate the immune response and achieve allergen tolerance. Precise dosing and efficacy of these preparations is crucial for the success of the therapy. However, it was not previously possible to quantify the allergoid content in the finished medicinal product. The Paul-Ehrlich-Institut is responsible for monitoring the quality, efficacy, and safety of therapy allergens. These medicinal products are required by law to undergo official batch testing, which is carried out at the Paul-Ehrlich-Institut. A research group of scientists from the Allergology and Veterinary Medicine Divisions at the Paul-Ehrlich-Institut under the direction of Dr Frank Führer, Deputy Head of the Allergens Product Testing Section in the Allergology Division, has developed a method that enables precise quantification of the allergoid content in AIT products with grass pollen allergoids. An ELISA (enzyme-linked immunosorbent assay)-like antibody-based detection method was developed for quantification using a fluorescence detection system. The antibodies used are highly specific and enable the exact determination of the allergoid content in the therapy allergen products. The newly developed immunoassay allows for precise measurement of the allergoid content of medicinal products. The research shows that this test can be used to reliably detect specific grass pollen allergoids without having to rely on animal testing. The introduction of this test significantly improves the quality assurance of AIT preparations and could contribute to their standardisation.