凝血因子Ⅸ纳米膜过滤条件的优化

Optimization of filtration of Factor IX through nano membrane filtration

目的提高纳米膜单位面积内凝血因子Ⅸ(FⅨ)的过滤量。方法采用正交试验设计方法,检验不同蛋白质浓度0.5、0.6、0.7 mg/m L FⅨ;温度4.0、15.0、25.0℃;预过滤膜类型:分别为Millipore(0.1μm、10 cm2),PALL(0.1μm、10 cm2),3M(0.1μm、10 cm2)对FⅨ过滤量的影响,记录2 h FⅨ过滤总量,分析比较过滤优化条件。结果0.7 mg/m L的FⅨ,25℃时,能使20 nm纳米膜的过滤载量由7.6㎏/m2提高至10.2㎏/m2。结论通过优化FⅨ浓度、过滤温度及滤膜类型等条件,可明显提高纳米膜对FⅨ的过滤载量,从而降低生产过程中纳滤膜过滤的成本。

Objective To improve the quantity of Factor IX in nano membrane filtration and to evaluate the performance of the filters. Methods Using the orthogonal experimental design method, different Factor IX protein concentrations at 0. 5, 0. 6 and 0. 7 mg/ml were tested at different temperatures of 4. 0, 4. 0, 15.0 ℃ The filtration membrane types were millipore （0. 1 μm, 10 cm2）, PALL （0. 1 μm,10 cm2）, 3m （0. 1 μm, 10 cm2） , respectively. The effect of the filtration membrane was elucidated on the quantity of Factor IX. The amount of filtration of Factor IX were recorded. Conditions for optimized filtration were analyzed. Results When Factor IX protein concentration was 0.7 mg/mL at 25℃, the capacity of 20 nm nano membrane filtration could increase from 7.6 kg/m2 to 10. 2 kg/m2. Conclusion By optimizing Factor IX concentration and filtration conditions such as temperature and membrane type, the amount of factor IX production can be enhanced and the cost of nano membrane filtration can be reduced during the production process.