Allergoid Content material Assay (ACA). (A) Schematic illustration of ACA. Particular person parts of the assay are depicted. (B) Proof of Idea of ACA and willpower of sensitivity. Imply alerts from three unbiased assays carried out in triplicates of testing adjuvanted grass pollen allergoid AIT product A (purple) or an aluminum hydroxide management (grey) with anti-grass pollen allergoid serum 1 (#S1, steady line), anti-Phl p 5 mAb (mAb, dashed line); or pre-immune serum (#S1 pre, dotted line). AU, arbitrary fluorescence models. Error bars point out customary deviation SD. Restrict of detection (LoD) displayed for anti-grass pollen allergoid serum 1 (#S1, steady line) and anti-Phl p 5 mAb (mAb, dashed line). Credit score: Allergy (2025). DOI: 10.1111/all.16543
An interdisciplinary analysis group from the Allergology and Veterinary Medication Divisions on the Paul-Ehrlich-Institut (PEI) has developed a novel laboratory check that permits the willpower of adjuvanted allergoids in completed medicinal merchandise. Content material analyses of completed medicinal merchandise weren’t potential previously as a result of complicated construction of this medicinal product group, which comprises each adjuvants and allergoids (chemically modified allergens) and due to this fact needed to be carried out on an middleman manufacturing step.
The brand new check technique represents important progress within the high quality management of medicines for allergy remedy. The journal Allergy stories on the outcomes.
Allergen immunotherapy (AIT) is used to deal with allergic reactions. Allergoids are chemically modified allergens which might be utilized in particular immunotherapy to modulate the immune response and obtain allergen tolerance. Exact dosing and efficacy of those preparations is essential for the success of the remedy. Nonetheless, it was not beforehand potential to quantify the allergoid content material within the completed medicinal product.
The Paul-Ehrlich-Institut is chargeable for monitoring the standard, efficacy, and security of remedy allergens. These medicinal merchandise are required by regulation to endure official batch testing, which is carried out on the Paul-Ehrlich-Institut.
A analysis group of scientists from the Allergology and Veterinary Medication Divisions on the Paul-Ehrlich-Institut beneath the course of Dr. Frank Führer, Deputy Head of the Allergens Product Testing Part within the Allergology Division, has developed a technique that permits exact quantification of the allergoid content material in AIT merchandise with grass pollen allergoids.
An ELISA (enzyme-linked immunosorbent assay)-like antibody-based detection technique was developed for quantification utilizing a fluorescence detection system. The antibodies used are extremely particular and allow the precise willpower of the allergoid content material within the remedy allergen merchandise.
The newly developed immunoassay permits for exact measurement of the allergoid content material of medicinal merchandise. The analysis reveals that this check can be utilized to reliably detect particular grass pollen allergoids with out having to depend on animal testing. The introduction of this check considerably improves the standard assurance of AIT preparations and will contribute to their standardization.
Extra info:
S. Schlünder et al, Immunological In Vitro Assay for Quantification of Adjuvanted Allergoids, Allergy (2025). DOI: 10.1111/all.16543
Supplied by
Paul Ehrlich Institute
Quotation:
New check improves high quality management of allergy therapeutics (2025, June 6)
retrieved 6 June 2025
from https://medicalxpress.com/information/2025-06-quality-allergy-therapeutics.html
This doc is topic to copyright. Other than any truthful dealing for the aim of personal research or analysis, no
half could also be reproduced with out the written permission. The content material is offered for info functions solely.
