| 摘要 |
Disclosed is a pharmaceutical composition comprising: (a) an HCP-reduced anti-IL-12 antibody, or antigen binding portion thereof, preparation produced by (1) subjecting a sample mixture comprising an anti-IL-12 antibody, or antigen binding portion thereof, and at least one HCP, and wherein said sample mixture has not been exposed to Protein A, to a reduction in pH thus forming a primary recovery sample, wherein said reduction in pH is to between 3 and 4; (2) adjusting said primary recovery sample to a pH of between about 4.5 and 6 followed by; (3) applying said primary recovery sample to an ion exchange resin and collecting an ion exchange sample; (4) applying said ion exchange sample to a hydrophobic interactive chromatography (HIC) resin, washing said resin with a 25 mM sodium phosphate, 0.85 M ammonium sulfate wash buffer at pH 7, and collecting an HIC sample, wherein said HIC sample comprises said HCP-reduced anti-IL-12 antibody, or antigen binding portion thereof, preparation; (b) and a pharmaceutically acceptable carrier. |
