Abstract：
Endotoxin testing by recombinant factor C (rFC) is increasing with the addition of new suppliers of reagents. By use of a recombinantly produced factor C , based on the sequence of a coagulation enzyme present in horseshoe crab amebocyte lysates, the rFC tests are designed as substitutes for the traditional Limulus amebocyte lysate (LAL)/Tachypleus amebocyte lysate tests based on horseshoe crab blood. Comparative testing of samples with both the LAL and recombinant reagents has shown a high degree of correlation, suggesting that use of rFC is comparable to the more traditional LAL tests and may be technologically superior. Recombinant factor C does not recognize the factor G pathway, the alternate coagulation pathway that the lysate reagents detect. This feature allows rFC to detect endotoxin more selectively. As a recombinantly produced material, it avoids the use of the horseshoe crabs required for lysate production, thereby protecting this species, which is at risk in some parts of the world. Recombinant factor C is expected to further benefit from a more sustainable supply chain based upon a robust biotechnological production process. We summarize here the results of many studies that evaluated the use of recombinant technology for the detection of environmental endotoxin. Additionally, we include a review of the current compendia and regulatory status of the recombinant technologies for use in the quality control of pharmaceutical manufacturing. Our analysis confirms that the recombinant technologies are comparable in protecting patient safety.
摘要：
随着新试剂供应商的加入，重组因子C（rFC）的内毒素测试正在增加。通过使用重组产生的因子C，基于horse蟹变形细胞裂解物中存在的凝固酶的序列，rFC测试被设计为替代传统的以马蹄蟹血为基础的Liu形细胞裂解物（LAL）/Tachypleus形细胞裂解物测试。用LAL和重组试剂对样品进行的比较测试显示出高度的相关性，这表明rFC的使用与更传统的LAL测试相当，并且在技术上可能更优越。重组因子C不识别因子G途径，裂解物试剂检测的替代凝血途径。该特征允许rFC更有选择性地检测内毒素。作为一种重组生产的材料，它避免了使用裂解物生产所需的马蹄蟹，从而保护这个物种，这在世界某些地区处于危险之中。重组因子C有望进一步受益于基于强大的生物技术生产工艺的更可持续的供应链。我们在此总结了许多评估重组技术用于检测环境内毒素的研究结果。此外,我们包括对重组技术用于药品生产质量控制的现行药典和监管状况的审查。我们的分析证实，重组技术在保护患者安全方面具有可比性。
