Burnouf-Radosevich M, Appourchaux P, Huart J J, Burnouf T
Centre Régional de Transfusion Sanguine, Lille, France.
Vox Sang. 1994;67(2):132-8. doi: 10.1111/j.1423-0410.1994.tb01647.x.
We have validated the use of two new regenerated multilayered structured cellulose membranes (BMM), Planova 15 N and Planova 35 N, with respective mean pore sizes of 15 and 35 nm, as a new filtration system to eliminate viruses in highly purified factor IX and factor XI concentrates. Virus spiking experiments indicated that single dead-end filtration on the membranes could remove more than 5.7-7.8 log10 of human immunodeficiency virus, bovine viral diarrhoea virus, porcine pseudorabies virus, reovirus type 3, and simian virus 40, as well as the small non-enveloped viruses, poliovirus Sabin type 1 and bovine parvovirus. In vitro control tests and animal studies (Wessler stasis model, rat hypotension model) of the two concentrates did not reveal any significant differences with the non-nanofiltered material. Viral filtration of plasma derivatives on porous polymeric membranes might be an essential step in the improvement of their viral safety.
我们已验证了两种新型再生多层结构纤维素膜（BMM），即平均孔径分别为15纳米的Planova 15 N和35纳米的Planova 35 N，可作为一种新型过滤系统，用于去除高纯度凝血因子IX和凝血因子XI浓缩物中的病毒。病毒加标实验表明，在这些膜上进行单次死端过滤可去除超过5.7 - 7.8个对数10的人类免疫缺陷病毒、牛病毒性腹泻病毒、猪伪狂犬病病毒、呼肠孤病毒3型和猿猴病毒40，以及小型无包膜病毒，如脊髓灰质炎病毒1型（Sabin株）和牛细小病毒。这两种浓缩物的体外对照试验和动物研究（韦氏停滞模型、大鼠低血压模型）未发现与未经过纳米过滤的材料有任何显著差异。在多孔聚合物膜上对血浆衍生物进行病毒过滤可能是提高其病毒安全性的关键步骤。
