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Dev Biol (Basel). 2005;122:145-52.

Characterization of allergen extracts.

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  • 1Laboratory of Immunobiochemistry, Division of Bacterial Parasitic and Allergenic Products, Office of Vaccines Regulation and Research, CBER/USFDA, Bethesda, MD, USA.


Allergen vaccines are complex extracts of natural products, and are used for the diagnosis and treatment of allergic diseases. In the U.S., 19 allergen extracts have been standardized. For these vaccines, the potency is estimated by the skin test responses of highly allergic individuals, and surrogate in vitro tests are established for lot release and quality control. The surrogate tests differ for different extracts. National reference standards to which manufactured lots are compared are maintained at FDA/CBER. Allergen standardization has facilitated the establishment of data-driven release limits.

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