Li Qiangyi, Macdonald Shirley, Bienek Carol, Foster Peter R, Macleod Alex J
Protein Fractionation Centre, Scottish National Blood Transfusion Service, Ellen's Glen Road, Edinburgh EH17 7QT, UK.
Biologicals. 2005 Jun;33(2):101-10. doi: 10.1016/j.biologicals.2005.02.001. Epub 2005 Apr 26.
The ability of ultraviolet (UV) light to inactivate viruses is well established. However, attempts to apply this to the manufacture of pharmaceutical proteins have been limited by incomplete treatment, low capacity or excessive dilution. Effective processing of large-scale batches of UV-opaque protein solutions has been achieved using a continuous-flow device. The operation of this device has been modelled and a design equation derived to relate the processing conditions and product characteristics to the degree of virus inactivation obtained. Variables included in the model are UV-absorbance at 254 nm (A(254)), hydrodynamic properties of the protein solution, residence time, intensity of UV light and diameter and length of irradiation tube. With this information a specific constant was calculated for each virus which denotes its relative sensitivity to UV and from which the degree of virus inactivation expected can be estimated.
紫外线（UV）使病毒失活的能力已得到充分证实。然而，将其应用于药用蛋白质生产的尝试受到处理不完全、容量低或过度稀释的限制。使用连续流动装置已实现对大量紫外线不透明蛋白质溶液的有效处理。对该装置的运行进行了建模，并推导出一个设计方程，以将处理条件和产品特性与获得的病毒灭活程度相关联。模型中包括的变量有254nm处的紫外线吸光度（A(254)）、蛋白质溶液的流体动力学性质、停留时间、紫外线强度以及照射管的直径和长度。利用这些信息，为每种病毒计算出一个特定常数，该常数表示其对紫外线的相对敏感性，并可据此估计预期的病毒灭活程度。
