DEVELOPMENT OF MOLECULAR BIOLOGICAL METHODS TO VACCINE AND CELL SUBSTRATE SAFETY

疫苗和细胞基质安全的分子生物学方法的开发

• 批准号: 6161253
• 负责人: K PEDEN
• 金额: --
• 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/6161253
• 关键词: Retroviridae; drug quality /standard; human tissue; nucleic acid sequence; polymerase chain reaction; vaccines

We are establishing, modifying, and developing at CBER sensitive assays for the detection of retroviruses. With the recent publication of three extremely sensitive assays to measure reverse transcriptase (RT) activity and the finding that certain licensed vaccines contain RT activity, it became necessary that CBER set up and investigate these assays biochemically in order to ascertain what precisely they were measuring. Because RT is usually associated with a retroviral particle, it was possible that those vaccines in which RT activity was found were contaminated with low amounts of a retrovirus whose presence was only revealed by the new and more sensitive assays. In fact, these sensitive RT assays do detect minor activities of cellular enzymes, and part of our program at CBER is to develop assays capable of discriminating between the two. This will be important in order to be able interpret any positive signals found in biological products destined for human and veterinary use. Our work involves using applying and developing assays to measure the presence of very low levels of retrovirus contamination in vaccines and cell substrates. The use of such methods is critical to the mission of the FDA in ensuring the safety of the products we regulate. Because of the ever-present possibility that new viruses that are pathogenic to humans will emerge, it should be obvious to all that CBER must be able to respond quickly to contingencies as they arise. To do this, it is necessary to have in-house expertise capable of applying, modifying, and developing new assays.

我们正在 CBER 建立、修改和开发敏感检测 用于检测逆转录病毒。 随着最近三本杂志的出版 用于测量逆转录酶 (RT) 活性的极其灵敏的测定 以及某些获得许可的疫苗含有 RT 活性的发现， CBER 有必要建立并研究这些检测方法 生化以确定他们测量的到底是什么。 由于 RT 通常与逆转录病毒颗粒相关，因此 那些发现 RT 活性的疫苗可能是 被少量逆转录病毒污染，其存在仅 新的、更灵敏的检测揭示了这一点。 事实上，这些敏感 RT 检测确实可以检测细胞酶的微小活性，以及​​我们的一部分 CBER 的计划是开发能够区分 二。 这对于能够解释任何积极的结果非常重要 用于人类和兽医的生物制品中发现的信号 使用。 我们的工作涉及使用应用和开发测定法来测量 疫苗中存在极低水平的逆转录病毒污染 细胞基质。 使用此类方法对于完成使命至关重要 FDA 确保我们监管的产品的安全。 由于 一种永远存在的可能性，即对人类致病的新病毒 人类将会出现，对于所有人来说，CBER 必须能够做到这一点应该是显而易见的 当突发事件发生时迅速做出反应。 要做到这一点，就是 必须拥有能够应用、修改和处理的内部专业知识 开发新的检测方法。