STANDARDIZATION AND SURVEILLANCE OF ALLERGENIC EXTRACTS

摘要：A.标有“无美国药效标准”的变应原提取物的标准化八种牧草(蒂莫西、六月、多年生黑麦、百慕大、红顶、果园、甜美春草和草甸羊茅)被标准化。过敏性提取物制造商一直在向LAIB提交他们的标准化草花粉提取物样本，以便在批准产品许可证申请补充剂之前进行测试。继续努力使三种蟑螂(美国蟑螂、德国蟑螂和东方蟑螂)、乳胶和花生标准化。B.标准变应原提取物的体外测试所有根据聚乳酸补充剂提交审批的草花粉提取物均在体外通过EL ISA竞争分析进行相对效力测试，以与IEF和BIEF Light的CBER参考标准相似，并通过改进的金刚三酮法测试蛋白质含量。所有批次的标准化变应原提取物的样品在复制之前都要提交CBER审批。LAIB审查样品协议，测试样品的效力，并视情况识别和接受/重新接收样品。LAIB正在研究一种评估毒液批量释放样本的新方法；研究已经完成，测试将很快开始。一种测量效力的新方法正在评估中。这种方法将定量和定性地测量与提取物结合的抗体的量。实验室还在考虑使用十二烷基硫酸钠-PAGE和Western Blot来评估当前的参考文献、支持解放军的批次和批次放行样本。标准化变应原提取物参考的管理LAIB提供制造商用于生产标准化变应原提取物的参考提取物。每个参考文献的定期补充是必要的。通过将市售提取物的效力和特性与当前参考文献进行比较来选择候选参考文献。候选人将接受一系列测试和统计分析，以确定与当前参考标准的可比性。然后选择替换参考。本财政年度建立的替代参考提取物：DF粉尘、多年生黑麦草、百慕大草、猫皮和猫里德校准剂。目前正在进行评估的替代参考提取物：DF粉尘和短豚草干草校准剂。短豚草的替代血清池的进程已经开始。为了提高稳定性，正在研究一种冷冻干燥的螨类参照物。

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.