Evaluation of the Biological Standardization of Native Der p 1, Der p 2 and Der p 23 Proteins Isolated from Natural Allergen Source

. Each allergen was isolated through an independent downstream process based on successive chromatographic steps, achieving high purity and preserving the structural integrity. Molecular standardization was performed in vivo in 27 mite-allergic patients by skin prick testing (SPT), enabling the separate determination of histamine equivalent potency (HEP) values: 7.43 µg/mL for nDer p 1, 8.11 µg/mL for nDer p 2, and 1.55 µg/mL for nDer p 23. These data establish a direct relationship between the protein concentration and biological activity for each major allergen. In conclusion, the successful production and biological standardization of native nDer p 1, nDer p 2, and nDer p 23 proteins provide well-defined reagents for in vivo molecular diagnosis and enable more precise and reproducible standardization compared with complex allergen extracts.