Plunkett Greg
ALK-Abelló, Inc., Round Rock, Texas, USA.
Curr Opin Otolaryngol Head Neck Surg. 2016 Jun;24(3):261-9. doi: 10.1097/MOO.0000000000000248.
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.
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.
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.
本文回顾了有关美国生产的变应原提取物稳定性的研究，这些研究有助于为批量浓缩物、稀释的患者检测和治疗小瓶的有效期设定提供指导，以及在温度异常升高后的调整。
为满足美国食品药品监督管理局（FDA）的要求，已完成了变应原稳定性研究，这些要求支持对标准化的豚草、尘螨、猫、草和毒液提取物标注有效期，但相关研究尚未发表。这些研究证明了50%甘油的稳定性增强参数，并支持FDA规定的非标准化提取物的有效期，甘油提取物的有效期是非甘油水性提取物的两倍。患者小瓶通常标注6 - 12个月的有效期。有充分证据表明人血清白蛋白可稳定低蛋白稀释小瓶。当混合时，诸如霉菌和昆虫等高蛋白酶变应原会降低花粉的效力。后续工作继续确定稀释剂对提取物稀释的影响、运输或冰箱故障偶尔出现的温度异常以及变应原的兼容性。
已确定了通常用于变应原免疫治疗的稀释剂对变应原稀释液的效价。将讨论这些研究以及各种储存条件下效价的变化和旨在改进我们对变应原提取物有效期指导的混合情况。
