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Review
. 2023 Apr;78(4):923-927.
doi: 10.1111/all.15631. Epub 2023 Jan 6.

Introduction of General Chapters on standard methods for allergen quantification in the European Pharmacopoeia

Julia Zimmer  1 , Andreas Bonertz  1 , Susanne Kaul  1 , Stefan Vieths  1
Affiliations
Review

Introduction of General Chapters on standard methods for allergen quantification in the European Pharmacopoeia

Julia Zimmer et al. Allergy. 2023 Apr.

Abstract

The Biological Standardization Project BSP090 has been successfully concluded in 2021. As a result, two standard methods for quantification of the major allergens Bet v 1 and Phl p 5 will be implemented in the European Pharmacopoeia (Ph. Eur.). The General Chapter describing the protocol of the respective Bet v 1-specific ELISA has already been adopted by the Ph. Eur. Commission and will become an official part of the Ph. Eur. in the beginning of 2023. As this will be the first allergen-specific standard method in the EU, this paper intends to summarize the preceding process and outline the measures necessary to comply with the new regulatory requirement.

Keywords: European pharmacopoeia; Phl p 5; allergen quantification; bet v 1; standardization.

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References

REFERENCES

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