Improved quality control of allergen products: Assessing the molecular allergen composition by mass spectrometry

IF 12.6 1区医学 Q1 ALLERGY

Allergy Pub Date : 2024-10-24 DOI:10.1111/all.16339

Steffen Augustin, Thomas Eichhorn, Martin Wald, Frank Fischer, Marek Jutel, Oliver Pfaar, Christoph Willers

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Abstract

Background

Natural allergen sources contain a variety of allergens, against which allergic subjects have developed individual sensitization profiles. Ideal allergen products for skin prick testing (SPT) and allergen immunotherapy (AIT) should contain the complete set of allergens of the respective allergen sources to cover all sensitization profiles. However, commercially available allergen products were shown to vary regarding their allergen composition.

Methods

The qualitative allergen composition of different SPT and AIT products produced from pollen of grasses, birch, mugwort and from house dust mites was assessed by a consistent high-resolution liquid chromatography-coupled tandem mass spectrometry method (LC–MS/MS).

Results

All major, mid-tier and most minor allergens were detected in each of the investigated three batches of SPT and AIT products, demonstrating the completeness of the allergen composition and a high degree of batch-to-batch consistency.

Conclusion

This is the first study using a single consistent high-resolution LC–MS/MS method to provide solid data on the qualitative allergen composition of SPT and AIT products manufactured from various common allergen sources. The applied method showed high reliability in qualitative batch-to-batch consistency testing and can be performed fast and with high throughput. High-resolution LC–MS/MS is applicable for process development and quality control to ensure market availability of allergen products corresponding to the composition of the respective natural allergen sources.

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改进过敏原产品的质量控制：通过质谱法评估分子过敏原成分。

背景天然过敏原来源含有多种过敏原，过敏受试者对这些过敏原会产生不同的过敏特征。用于皮肤点刺试验（SPT）和过敏原免疫疗法（AIT）的理想过敏原产品应包含相应过敏原来源的全套过敏原，以涵盖所有过敏特征。方法采用一致的高分辨率液相色谱-耦合串联质谱法（LC-MS/MS）评估了由草、桦树、艾草花粉和屋尘螨生产的不同 SPT 和 AIT 产品的定性过敏原组成。结果在所调查的三个批次的 SPT 和 AIT 产品中，每个批次都检测到了所有主要、中级和大多数次要过敏原，这表明过敏原成分的完整性和批次间的高度一致性。所应用的方法在批次间定性一致性测试中表现出高度可靠性，并且可以快速、高通量地执行。高分辨率 LC-MS/MS 适用于工艺开发和质量控制，以确保市场上的过敏原产品与相应天然过敏原来源的成分一致。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Allergy 医学-过敏

CiteScore

26.10

自引率

9.70%

发文量

393

审稿时长

2 months

期刊介绍： Allergy is an international and multidisciplinary journal that aims to advance, impact, and communicate all aspects of the discipline of Allergy/Immunology. It publishes original articles, reviews, position papers, guidelines, editorials, news and commentaries, letters to the editors, and correspondences. The journal accepts articles based on their scientific merit and quality. Allergy seeks to maintain contact between basic and clinical Allergy/Immunology and encourages contributions from contributors and readers from all countries. In addition to its publication, Allergy also provides abstracting and indexing information. Some of the databases that include Allergy abstracts are Abstracts on Hygiene & Communicable Disease, Academic Search Alumni Edition, AgBiotech News & Information, AGRICOLA Database, Biological Abstracts, PubMed Dietary Supplement Subset, and Global Health, among others.