Arrighi S, Pacenti L, Borri M G
Sclavo Biotechnology Center, Siena, Italy.
Vox Sang. 1993;64(1):13-8. doi: 10.1111/j.1423-0410.1993.tb02508.x.
This study was carried out with the aim of developing a production process for the manufacture of a highly purified factor VIII concentrate which is virus inactivated by pasteurization in liquid phase. Beside standard plasma protein separation techniques, the procedure uses a chromatographic step on anion exchanger, whose selectivity is increased by using high, but not destabilizing salt concentrations. The final product before stabilization has a specific activity higher than 300 IU/mg of protein, namely the highest specific activity reported for human factor VIII concentrates purified without the use of immunoadsorbents.
本研究旨在开发一种生产工艺,用于制造高纯度的凝血因子VIII浓缩物,该浓缩物在液相中通过巴氏灭菌法进行病毒灭活。除了标准的血浆蛋白分离技术外,该工艺还在阴离子交换剂上采用了色谱步骤,通过使用高浓度但不会破坏稳定性的盐来提高其选择性。稳定化之前的最终产品比活性高于300 IU/mg蛋白质,这是报道的在不使用免疫吸附剂的情况下纯化的人凝血因子VIII浓缩物的最高比活性。