Manabe S
Fukuoka Women's University, Japan.
Dev Biol Stand. 1996;88:81-90.
To protect against virus infections, the new technology of the virus removal membrane has been developed. The novel virus removal filter PLANOVA is validated for virus removal, that is, reproducible and predictable. The removal is based on the sieving mechanism. The removal of viruses by PLANOVA with a given mean pore size ranging between 10 and 75 nm is predictable when the geometrical size and the deformability of the virus are known in advance under the given filtration conditions. The high removability of viruses originates from the unique pore structure, that is the structure of the multi-layer (or multi-screen) each of which is composed of two types of pores, the capillary and void pores. The good recovery rate of proteins is attained by using material with a good hydroscopic property such as regenerated cellulose. Designing the worst case of the process and selecting model viruses in the process validation experiment are important in the practical application of PLANOVA. The integrity tests by the membrane producer and by the user have been established. Although PLANOVA has already worked well in the field of drug manufacture, the combination of virus removal using PLANOVA and virus inactivation treatment gives potentially wide application.
为了预防病毒感染，人们研发了病毒去除膜的新技术。新型病毒去除过滤器PLANOVA经过了病毒去除验证，即具有可重复性和可预测性。去除基于筛分机制。当在给定过滤条件下预先知道病毒的几何尺寸和可变形性时，PLANOVA对平均孔径在10至75纳米之间的病毒的去除是可预测的。病毒的高去除率源于独特的孔结构，即多层（或多筛）结构，每层由两种类型的孔组成，即毛细管孔和空隙孔。通过使用具有良好吸湿性的材料（如再生纤维素）可实现蛋白质的良好回收率。在PLANOVA的实际应用中，设计工艺的最坏情况并在工艺验证实验中选择模型病毒很重要。膜生产商和用户的完整性测试已经建立。尽管PLANOVA在药物制造领域已经运行良好，但将使用PLANOVA的病毒去除与病毒灭活处理相结合具有潜在的广泛应用前景。
