Update: stability of allergen extracts to establish expiration dating.
OBJECTIVE
The article reviews studies pertaining to US manufactured allergen extract stability that contribute to guidance for expiration dating for bulk concentrates, diluted patient testing and treatment vials, and adjustments following elevated temperature excursions.


RESULTS
Studies on allergen stability were completed to satisfy the Food and Drug Administration requirements supporting labeled expiration dating for standardized short ragweed, dust mites, cat, grass, and venom extracts and are not published. These studies demonstrated the stability enhancing parameters of 50% glycerin and support the Food and Drug Administration mandated expiration of nonstandardized extracts allowing glycerin extracts twice the dating of nonglycerin aqueous extracts. Patient vials are commonly given 6-12 months dating. There is adequate evidence that human serum albumin stabilizes low protein diluted vials. High protease allergens such as molds and insects compromised potency of pollens when mixed. Subsequent work continued to define the effects of diluents on extract dilutions, temperature excursions that occasionally occur with shipping or refrigerator malfunctions, and allergen compatibility.


CONCLUSIONS
Potency has been determined for allergen dilutions with diluents typically used for allergen immunotherapy. These studies along with changes of potency under various storage conditions and mixing designed to improve our guidance on expiration dating of allergen extracts will be discussed.
ALK-Abelló, Inc., Round Rock, Texas, USA.
Greg
G
Plunkett
D000485:Allergens; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D007167:Immunotherapy
D000485:Allergens