Patent ID: 8546548
Filing Date: 2013-10-01
Classification: A61K,A61P,B01D,C07K

Abstract:
1. A method for preparing a concentrated immunoglobulin G (IgG) composition, comprising the steps: (A) concentrating a first solution comprising IgG to a protein concentration of from 2% to 10% (w/v) by ultrafiltration using a first ultra-/diafiltration system comprising a first ultrafiltration membrane, thereby forming a first IgG concentrate; (B) diafiltering the first IgG concentrate against a diafiltration buffer using the first ultra-diafiltration system comprising the first ultrafiltration membrane, thereby forming a first IgG diafiltrate; (C) concentrating the first IgG diafiltrate to a protein concentration of greater than 20% (w/v) by ultrafiltration using the first ultra-/diafiltration system comprising the first ultrafiltration membrane, thereby forming a second IgG concentrate; (D) collecting the second IgG concentrate from the first ultra-/diafiltration system; (E) washing the first ultrafiltration membrane by re-circulating a post-wash buffer through the first ultra-/diafiltration system wherein the first ultra-/diafiltration system is washed with a volume of post-wash buffer equal to at least two times the dead volume of the first ultra-/diafiltration system, thereby forming a first IgG post-wash solution; (F) transfering the first IgG post-wash solution from the first ultra-/diafiltration system into a second ultra-/diafiltration system comprising a second ultrafiltration membrane, wherein the surface area of the second ultrafiltration membrane is lower than the surface area of the first ultrafiltration membrane; (G) concentrating the first IgG post-wash solution to a protein concentration of greater than 20% (w/v) by ultrafiltration using the second ultra-/diafiltration system comprising a second ultra-/diafiltration membrane, thereby forming a third IgG concentrate; and (H) combining the third IgG concentrate from the second ultra-/diafiltration system with the second IgG concentrate, thereby forming a concentrated IgG composition.