STANDARDIZATION AND SURVEILLANCE OF ALLERGENIC EXTRACTS

A.标有“无美国标准”的过敏原提取物的标准化 效力“ 八种牧草(蒂莫西，六月，多年生黑麦，百慕大，红顶，果园， 甜蜜的春天和草地羊茅)是标准化的。致敏萃取物 制造商已经提交了他们的标准化草的样品 在产品批准之前，将花粉提取液送到LAIB进行测试 许可证申请补充。继续努力实现标准化 三种蟑螂(美国蟑螂、德国蟑螂和东方蟑螂)、乳胶和花生。 B.对所有草花粉的标准化变应原提取物的体外测试 根据解放军补充剂提交审批的提取物在体外进行测试 用与CBER相似的EL ISA竞争分析进行相对效价 IEF和BIEF Light的参考和改良的蛋白质含量 金刚烷法。所有批次的标准变应原提取物样品 在复制之前提交CBER审批。莱布回顾了 样本协议，测试样本的效力并识别和 视情况接受/拒绝样品。 莱布正在研究一种评估毒液批量释放的新方法 样本；研究已经完成，不久将开始测试。 一种测量效力的新方法正在评估中。此方法将 定量和定性地测量结合的抗体的量 摘录。实验室还在考虑使用十二烷基硫酸钠-PAGE和 Western Blot在评价目前的参考文献时，很多人都支持 解放军和批次放行样品。 C.LAIB提供的标准化变应原提取物参考文献的管理 制造商用来生产标准化产品的参比提取物 过敏性提取物。每个参考资料的定期补充是 这是必要的。候选引用的选择是通过比较效力和 商业上可获得的提取物与当前参考文献的一致性。这个 考生要接受一系列测试和统计分析 以便于与当前引用进行比较。替代引用是 然后被选中。在本财政年度建立的替代参考摘录 年份：粉尘螨、多年生黑麦草、百慕大草、猫毛和猫草 校准器。目前正在进行的替代参考提取物 评价：DF粉尘和短豚草除草剂。这是一种- 短豚草的替代血清池已经开始。冻干的尘螨 正在对参照物进行研究，以提高稳定性。

A. Standardization of Allergenic Extracts Labeled "No U.S.Standard of Potency" Eight grasses (timothy, june, perennial rye, bermuda, redtop, orchard, sweet vernal, and meadow fescue) were standardized. Allergenic extract manufacturers have been submitting samples of their standardized grass pollen extracts to LAIB for testing prior to approval of the Product License Application Supplements. Efforts continue for the standardization of three cockroaches (American, German, and Oriental), latex and peanut. B. In Vitro Testing of Standardized Allergenic Extracts All grass pollen extracts submitted for approval under a PLA supplement are tested in vitro for relative potency by ELISA Competition Assay for similarity to the CBER reference by IEF and BIEF Light and for protein content by the Modified Ninhydrin Method. Samples of all lots of standardized allergenic extracts are submitted to CBER for approval before duplication. LAIB reviews the sample protocols, tests the samples for potency and identifies and accepts/rejects the sample as appropriate. LAIB is investigating a new method for evaluating venom lot release samples; the research has been completed and testing will begin shortly. A new method for measuring potency is being evaluated. This method would quantitatively and qualitatively measure the amount of antibody bound to the extract. The Laboratory is also considering the use of SDS-PAGE and Western Blot in the evaluation of current references, lots in support of PLA and lot release samples. C. Management of Standardized Allergenic Extract References LAIB provides the reference extracts used by the manufacturers to produce standardized allergenic extracts. Periodic replenishment of each reference is necessary. Candidate references are selected by comparing the potency and identity of commercially available extracts to the current reference. The candidates are subjected to a battery of tests and statistical analysis for comparability to the current reference. A replacement reference is then chosen. Replacement reference extracts established during this fiscal year: Df Mite, Perennial Rye Grass, Bermuda Grass, Cat Pelt and Cat RID Calibrators. Replacement reference extracts currently undergoing evaluation: Df Mite and Short Ragweed RID Calibrators. The process for a- replacement serum pool for Short Ragweed has begun. A lyophilized Mite reference is being investigated for increased stability.