Allergen extracts prepared from purified mite bodies (PMB) and whole mite culture (WMC) were investigated by using in vivo and in vitro methods. PMB showed a more complex allergen pattern than WMC. In PMB, 6 out of 16 allergens could be detected as major allergens. In WMC, 5 out of 10 allergens could be detected as major allergens. Both extracts contained the same amount of the major allergen Der p I. By skin prick testing comparable results were obtained with both extracts. Investigation of the reproducibility showed that 15 production lots of PMB could be produced in a high conformity according to their allergenic potency and their protein and allergen composition.