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01-03-2016 | Immunologic/Diagnostic Tests in Allergy (M Chapman and A Pomés, Section Editors)

Standardization and Regulation of Allergen Products in the European Union

Authors: Julia Zimmer, Stefan Vieths, Susanne Kaul

Published in: Current Allergy and Asthma Reports | Issue 3/2016

Abstract

Product-specific standardization is of prime importance to ensure persistent quality, safety, and efficacy of allergen products. The regulatory framework in the EU has induced great advancements in the field in the last years although national implementation still remains heterogeneous. Scores of methods for quantification of individual allergen molecules are developed each year and also the challenging characterization of chemically modified allergen products is progressing. However, despite the unquestionable increase in knowledge and the subsequent improvements in control of quality parameters of allergen products, an important aim has not been reached yet, namely cross-product comparability. Still, comparison of allergen product potency, either based on total allergenic activity or individual allergen molecule content, is not possible due to a lack of standard reference preparations in conjunction with validated standard methods. This review aims at presenting the most recent developments in product-specific standardization as well as activities to facilitate cross-product comparability in the EU.

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Title: Standardization and Regulation of Allergen Products in the European Union
Authors: Julia Zimmer
Stefan Vieths
Susanne Kaul
Publication date: 01-03-2016
Publisher: Springer US
Published in: Current Allergy and Asthma Reports / Issue 3/2016
Print ISSN: 1529-7322
Electronic ISSN: 1534-6315
DOI: https://doi.org/10.1007/s11882-016-0599-4

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Standardization and Regulation of Allergen Products in the European Union

Abstract

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

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