VIRAL INACTIVATION DURING PURIFICATION OF IL-12 AND IL-18 ANTIBODIES

摘要

Disclosed is a method for producing a host cell protein (HCP) reduced antibody, or antigen binding portion thereof, preparation from a sample mixture comprising an antibody, or antigen binding portion thereof, an HCP and a viral particle, wherein said sample mixture has not been exposed to Protein A, and wherein the preparation comprises a decreased viral activity in comparison to the sample mixture, said method comprising: Subjecting said sample mixture to a reduction in pH thus forming a primary recovery sample, wherein said reduction in pH is to a pH of 3.8 and said reduction is achieved by the addition of citric or phosphoric acid; Adjusting said primary recovery sample to a pH of about 4.5 to about 6.5 followed by; Applying said primary recovery sample to an ion exchange resin and collecting an ion exchange sample; and Applying said ion exchange sample to a hydrophobic interactive chromatography (HIC) resin and collecting an HIC sample, wherein said HIC sample comprises said HCP-reduced antibody, or antigen binding portion thereof, preparation.