STANDARDIZATION AND SURVEILLANCE OF ALLERGENIC EXTRACTS

摘要： a. 标记为"无美国效价标准"的过敏性提取物的标准化 八个草（提摩太，六月，多年生黑麦，百慕大，红顶，果园，甜春，和草甸牛毛草）进行了标准化。致敏提取物制造商已将其标准化草花粉提取物样品提交给LAIB进行测试，然后再批准产品许可证申请补充材料。 三种蟑螂（美洲、德国和东方）、乳胶和花生的标准化工作仍在继续。 B。 标准化致敏性提取物的体外试验根据PLA补充剂提交批准的所有草花粉提取物均通过ELISA竞争试验进行体外相对效价试验，通过IEF和BIEF Light检测与CBER参考品的相似性，并通过改良茚三酮法检测蛋白质含量。所有批次的标准化过敏性提取物的样品在复制前提交给CBER批准。 LAIB审查样品方案，检测样品的效价，并酌情鉴别和接受/重新样品。 LAIB正在研究一种新的方法来评估毒液批次放行样品;研究已经完成，测试将很快开始开始。正在评估一种测量效力的新方法。该方法将定量和定性测量与提取物结合的抗体的量。 实验室还考虑使用SDS-PAGE和蛋白质印迹法评价当前参比品、支持PLA的批次和批放行样品。 C. 标准化致敏性提取物参考品的管理LAIB提供了生产商用于生产标准化致敏性提取物的参考提取物。 必须定期补充每一参考资料。 通过比较效价和 市售提取物与当前参比品的鉴别。 候选人将接受一系列测试和统计分析，以与当前参考进行比较。 然后选择替换参考。本财政年度确定的替代参比浸提液：Df Mite、Perennial Rye Grass、Bermuda Grass、Cat Pelt和Cat RID校准品。 目前正在接受评价的替代参比浸提液：Df Mite和Short Ragweed RID校准品。 短豚草的替代血清池的过程已经开始。正在研究冻干螨参比品的稳定性。

ABSTRACT: 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/re 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.