What is standardization and how do manufacturers standardize extracts?
The FDA, Laboratory of Immunobiochemistry, established a program to develop potency standards for allergenic extracts. The purposes of the program were to assure that widely used allergenic extracts were biologically active and exhibit similar potency from lot to lot and among manufacturers.Under this program the FDA establishes testing methods and potency standards. Each company that manufactures a standardized product must test it by an FDA approved method using approved testing reagents.Which products are standardized?Currently 19 allergenic extracts are standardized:Insect venom proteins are standardized on the basis of the total micrograms of venom protein in the product. In addition, each manufacturer must confirm the presence of key allergens hyaluronidase and phospholipase A in each batch. The standardized insect venom proteins include: Honey bee Yellow jacket Wasp White-faced hornet Yellow hornetMixed vespid (equal mixtures of white faced hornet, yellow jacket, and yellow horn
