Patent ID: 11919925
Assignee: ALEXION PHARMACEUTICALS, INC.
Field: Chemical engineering (Chemistry)
Classification: CPC C  B | IPC A  B  C

Claim 12:
13. A method of performing viral filtration, the method comprising the steps of:
(a) adjusting the pH of a fluid comprising a recombinant antibody to between about 5.0 and about 6.7, and adding a stabilizing agent to the fluid in an amount sufficient to yield a final concentration of between about 0.1 mM and about 25 mM stabilizing agent in the fluid;
(b) performing ultrafiltration/diafiltration on the fluid;
(c) following step (b), flowing the fluid through a pre-filter, wherein the pre-filter comprises a polyamide membrane; and
(d) immediately following step (c), flowing the fluid through a virus filter to produce a filtrate comprising the recombinant antibody,
wherein:
(i) the stabilizing agent is selected from the group consisting of arginine, alanine, aspartic
acid, glutamic acid, leucine, lysine, histidine, glycine, sucrose, trehalose, mannitol, and sorbitol;
(ii) the recombinant antibody comprises: a heavy chain variable region comprising: the CDR1 comprising a sequence of SEQ ID NO: 1, the CDR2 comprising a sequence of SEQ ID NO: 2, and the CDR3 comprising a sequence of SEQ ID NO: 3, and a light chain variable region comprising: a CDR1 comprising a sequence of SEQ ID NO: 6, a CDR2 comprising a sequence of SEQ ID NO: 7, and a CDR3 comprising a sequence of SEQ ID NO: 8.