Abstract

The high level of removability of virus in the purification process of bio-drugs such as 5 logs removal draws the new concept of membrane structure. The novel structure is represented by the multi-layers, each of which shows the characteristics of a screen filter, resulting in the multi-steps filtration. In this review the preparation method of the membrane with multi-layers and its performance of virus removal and protein permeability are dealed with. In order to apply the me-mbrane in the actual purification process, the membrane should be validatable, that is, reproducible and predictable in virus removal. The combination of two type tests of a breakage and a non-breakage tests is employed in the manufacturing process of the membrane. The test for the confirmation of mean characteristic values such as mean pore size is an example of breakage tests and the pressure hold test is one of non-breakage tests. This combination makes the membrane validatable. The users of this membrane should carry out the integrity test developed for the membrane manufacturer. The target particle to be removed spread widely such as prion proteins and DNA. The mechanism of separation of fine particles has been clarified and then, the new separation method of diffusion using the membrane may be succesful in future.

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