Development and Evaluation of Standards for Assessing the Biological Activity of Allergens

The guidelines for construction and approval of international standards and reference reagents of biological substances according to which allergens, like all immunobiological drugs, should be standardized were described. The units of biological (allergic) activity for the first batch of standard are determined in vivo (provocative tests, intradermal tests, skin-prick test, etc.) in sensitized persons. The activity of the first batch of the standard is also studied in parallel by immunoassay methods using inhibition of serum containing allergen-specific IgE. The standard should also be characterized with respect to content of main (major) allergenic proteins, protein profile, and protein structure. Modern requirements for allergen preparations were introduced for the first time in the XIIIth Edition of the State Pharmacopoeia of the Russian Federation.