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New publication on an EDQM Biological Standardisation Programme study for standardisation of allergen products

European Pharmacopoeia
Biological standardisation programme (BSP)
03 August 2021
Strasbourg, France

Following the successful completion of the BSP090 study on recombinant major allergens, in collaboration with project leaders from the Paul-Ehrlich-Institut, an article on one of the major study outcomes “Validation of a candidate European Pharmacopoeia standard method for quantification of major grass pollen allergen Phl p 5” has recently been published in the scientific journal Allergy.

The BSP090 study successfully achieved the establishment of reference standards for the quantification of Bet v 1, the major allergen in the pollen from birch (Betula verrucosa), and Phl p 5, a primary allergen in the pollen of meadow timothy grass (Phleum pratense). Validation of standardised enzyme-linked immunosorbent assay (ELISA) methods for the two allergens was also part of the scope of the project. The inclusion of the ELISA for Bet v 1 in the European Pharmacopoeia has undergone public consultation in Pharmeuropa (31.4) and the text will shortly be proposed to the European Pharmacopoeia Commission for adoption.

The last phase of the BSP090 study was aimed at the validation of an ELISA method for Phl p 5a, and this was successfully completed in 2020. The method has been submitted for consideration for inclusion in the European Pharmacopoeia. A further article on the study outcome including more details on the method is expected to be published in Pharmeuropa Bio & Scientific Notes in the autumn.

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