Slater J E
Laboratory of Immunobiochemistry, Division of Bacterial Parasitic and Allergenic Products, Office of Vaccines Regulation and Research, CBER/USFDA, Bethesda, MD, USA.
Dev Biol (Basel). 2005;122:145-52.
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.
变应原疫苗是天然产物的复杂提取物，用于过敏性疾病的诊断和治疗。在美国，已有19种变应原提取物实现了标准化。对于这些疫苗，效力通过高度过敏个体的皮肤试验反应来评估，并建立了替代体外试验用于批放行和质量控制。不同提取物的替代试验有所不同。FDA/CBER保存了供生产批次与之比较的国家参考标准。变应原标准化有助于建立基于数据的放行限度。
