CHARACTERIZATION OF THE FACTOR VIII IN FACTOR VIII CONCENTRATES

因子 VIII 浓缩物中因子 VIII 的表征

• 批准号: 3792653
• 负责人: W FRICKE
• 金额: --
• 依托单位: CENTER BIOLOGICS EVALUATION RESEARCH HEMATOLOGY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3792653
• 关键词: activation product; analytical method; antibody formation; antibody specificity; antigens; bioassay; coagulation factor VIII; hemophilia As; platelet activation; western blottings

The factor VIII in factor VIII concentrates is being characterized by activity and antigen assays and by immunoblotting. The availability of factor VIII concentrates of increasing purity, including recombinant factor VIII, has raised concern about potency testing and potential immunogenicity resulting in increased numbers of hemophiliacs who form antibodies to factor VIII used as therapy. The potency of these products can be influenced by the state of activation of the factor VIII. This activated state can possibly be detected by the presence of factor VIII fragments known to be formed by thrombin cleavage, by an increase in activity relative to antigen, or by assays relatively specific for activated factor VIII. All factor VIII concentrates available in the U.S. or under review by FDA for licensure are being studied in an attempt to characterize their factor VIII and determine if there are differences among then in activation.

第八因子浓缩物中的第八因子的特征是 活性和抗原检测以及免疫印迹。是否可以使用 纯度不断提高的凝血因子VIII，包括重组人 第八因子，引起了人们对效力测试和潜在 免疫原性导致血友病患者数量增加 用于治疗的抗第VIII因子抗体。它们的威力 产品会受到该因子的激活状态的影响 Viii.这种激活状态可能通过以下方式检测到 已知的因子片段是由凝血酶裂解形成的，由一个 相对于抗原的活性增加，或通过相对 专为激活的第VIII因子。所有的第VIII因子浓缩 在美国上市或正在接受FDA审查的许可证正在 试图描述他们的第VIII因子，并确定 在激活方面，它们之间存在差异。