Abstract
RATIONALE: Standardization of allergen extracts requires availability of well-characterized recombinant allergens used as reference standards provided by the European regulatory authorities. The objective of this study was the detailed physicochemical and immunological characterization of rBet v 1.0101 and rPhl p 5.0109, which shall be used in a ring trial within the framework of the Biological Standardization Program BSP090 of the European Directorate for Quality of Medicines and Healthcare (EDQM).
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