DEVELOPMENT OF MOLECULAR BIOLOGICAL METHODS TO VACCINE AND CELL SUBSTRATE SAFETY

我们正在建立，修改，并在CBER敏感检测开发 用于检测逆转录病毒 随着最近出版的三本 用于测量逆转录酶（RT）活性的极其灵敏的测定 以及发现某些许可的疫苗含有RT活性， CBER有必要建立并研究这些检测方法 用生物化学的方法来确定他们到底在测量什么。 因为RT通常与逆转录病毒颗粒相关，所以它是 可能那些发现RT活性的疫苗 被少量的逆转录病毒污染， 新的更灵敏的检测方法揭示了这一点。 事实上，这些敏感的 RT分析确实检测到细胞酶的微小活性，并且我们的部分研究结果显示， CBER的一项计划是开发能够区分 两个. 这将是重要的，以便能够解释任何积极的 人类和兽用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来测量 疫苗中存在极低水平的逆转录病毒污染， 细胞基质 这些方法的使用对于执行联合国的使命至关重要。 确保我们监管的产品的安全性。 因为 新的致病性病毒 人类将出现，这应该是显而易见的，所有CBER必须能够 对突发事件迅速做出反应。 要做到这一点， 需要有内部的专业知识，能够应用，修改， 开发新的分析方法。

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.