Roberts P L, Dunkerley C, McAuley A, Winkelman L
Bio Products Laboratory, Elstree, Herts, UK.
Vox Sang. 2007 Jan;92(1):56-63. doi: 10.1111/j.1423-0410.2006.00845.x.
Dry heat treatment at 80 degrees C for 72 h is used as a virus inactivation step for some coagulation factor concentrates such as Bio Products Laboratory's (BPL) factor VIII 8Y. In the current study, the effect of this process has been tested on a range of viruses. In addition the effect of various manufacturing process parameters on virus inactivation has been investigated.
Samples of product intermediate were obtained from manufacturing, spiked with virus and subjected to freeze drying and dry heat treatment. Virus inactivation was determined by infectivity assay.
Freeze drying followed by dry heat treatment was effective for inactivating a wide range of enveloped and nonenveloped viruses. Sucrose or protein concentration had no effect on virus inactivation. Product presentation or the interruption of heat treatment also had no effect. The inactivation of some of the viruses was greater at higher residual water content but under such conditions the stability of the product was reduced.
This virus inactivation step was effective for a wide range of viruses and over the range of process conditions encountered in manufacturing. This demonstrates the robustness of this process step.
80摄氏度干热处理72小时被用作某些凝血因子浓缩物（如生物制品实验室（BPL）的VIII因子8Y）的病毒灭活步骤。在本研究中，已对该过程对一系列病毒的效果进行了测试。此外，还研究了各种生产工艺参数对病毒灭活的影响。
从生产过程中获取产品中间体样品，接种病毒，然后进行冷冻干燥和干热处理。通过感染性测定来确定病毒灭活情况。
冷冻干燥后进行干热处理对多种包膜病毒和非包膜病毒均有效。蔗糖或蛋白质浓度对病毒灭活没有影响。产品形式或热处理中断也没有影响。在较高残留水分含量下，某些病毒的灭活效果更好，但在这种情况下产品的稳定性会降低。
该病毒灭活步骤对多种病毒有效，且在生产过程中遇到的一系列工艺条件下均有效。这证明了该工艺步骤的稳健性。
