Technology Development, Planova Division, Asahi Kasei Medical Co. Ltd., 2700 Asahimachi 6-chome, Nobeoka, Miyazaki, Japan.
Biotechnol Prog. 2010 Jul-Aug;26(4):1080-7. doi: 10.1002/btpr.415.
We investigated the effect of antibody solution conditions (ionic strength, pH, IgG concentration, buffer composition, and aggregate level (dimer content)) on filter performance for a virus removal filtration process using the Planova 20N, a virus removal filter. Ionic strength and pH affected the filter flux. A consistent high flux was maintained at an ionic strength greater than 10 mM and at pH 4-8 under a typical buffer composition (sodium chloride, citrate, acetate, and phosphate). Optimum IgG concentration was 10-20 mg/mL allowing for high throughput (kg/m(2) of IgG). Dimer content negligibly affected the flux level. Under high throughput conditions, virus spiking did not affect flux whereas a parvovirus logarithmic reduction value greater than 5 was maintained. From the results of zeta potential analyses for IgG and the membrane, we considered that electrostatic interactions between antibodies and the membrane affect filter performance (flux level and throughput). These results indicate that the Planova 20N filter is applicable for a wide range of solution conditions typically used in antibody processing.
我们研究了抗体溶液条件（离子强度、pH 值、IgG 浓度、缓冲液组成和聚集体水平（二聚体含量））对使用 Planova 20N 病毒去除过滤器进行病毒去除过滤过程的过滤性能的影响。离子强度和 pH 值会影响过滤通量。在典型缓冲液组成（氯化钠、柠檬酸盐、醋酸盐和磷酸盐）下，离子强度大于 10 mM 且 pH 值为 4-8 时，可保持一致的高通量。最佳 IgG 浓度为 10-20 mg/mL，可实现高通量（每 kg/m(2) IgG 的通量）。二聚体含量对通量水平的影响可以忽略不计。在高通量条件下，病毒接种不会影响通量，而细小病毒的对数减少值大于 5 时可保持不变。根据 IgG 和膜的 ζ 电位分析结果，我们认为抗体和膜之间的静电相互作用会影响过滤性能（通量水平和高通量）。这些结果表明 Planova 20N 过滤器适用于抗体处理中常用的广泛溶液条件。
