Patent ID: 7108791

Claim:
A virus removal methodology, suitable for conducting a high-flux fluid separation of a virus from a protein in the course of biopharmaceutical manufacture, the methodology comprising the steps of: (a) providing a filtration device comprising a housing having a fluid inlet and a filtrate outlet, and containing at least two interfacially contiguous asymmetric membranes, wherein: (i) the asymmetric membranes are each substantially hydrophilic, (ii) at least two of the asymmetric membranes are each capable of substantially selectively preventing the passage therethrough of said virus and substantially permitting the passage therethrough of said protein, (iii) at least two of the asymmetric membranes have each a tight-side and an open-side, the average surface pore size of said tight-side being less than the average surface pore size of said open-side, and (iv) the foremost asymmetric membrane is oriented such that fluid introduced into said housing through the fluid inlet commences passage through said foremost asymmetric membrane through its open-side; (b) providing a manufactured protein-containing solution, wherein the predominant solute in said solution is said protein, and wherein the solution is prone to contamination by said virus; and (c) flowing said manufactured protein-containing solution through said filtration device using a normal flow filtration mode under conditions sufficient to effect substantial passage of said protein through each of said asymmetric membranes and out of said housing through said filtrate outlet, whereby any of said virus contaminating said manufactured protein-containing solution, being substantially prevented from passage through said asymmetric membranes, is substantially removed therefrom.