| 摘要 |
Disclosed herein are methods for the isolation and purification of anti-IL-13 antibodies wherein the use of an affinity chromatographic step results in an antibody composition sufficiently pure for pharmaceutical uses. The methods described herein comprise pH viral reduction/inactivation, ultrafiltration/diafiltration, affinity chromatography (e.g., Protein A affinity chromatography), ion exchange chromatography, and hydrophobic chromatography. Further, the present invention is directed toward pharmaceutical compositions comprising one or more antibodies of the present invention. |
| 主权项 |
1. A method for producing a host cell protein (HCP)-reduced anti-IL-13 antibody, or antigen-binding portion thereof, preparation from a sample mixture comprising an anti-IL-13 antibody, or antigen-binding portion thereof, and at least one HCP, said method comprising:
(a) contacting said sample mixture to a Protein A affinity chromatography resin, washing said affinity chromatography resin with a buffer comprising 25 mM Tris, 100 mM NaCl, pH 7.2, followed by a buffer comprising 20 mM sodium citrate/citric acid, 0.5 M NaCl, pH 6.0, and then with a buffer comprising 25 mM Tris, 100 mM NaCl, pH 7.2, and collecting an affinity chromatography sample; (b) subjecting said affinity chromatography sample to a reduction in pH thus forming a reduced pH sample, wherein said reduced pH sample has a pH of about 3 to about 4; (c) adjusting said reduced pH sample to a pH of about 4.5 to about 8.5 and contacting said adjusted pH sample to an ion exchange material and collecting an ion exchange sample; (d) contacting said ion exchange sample to a hydrophobic interaction chromatography (HIC) material and collecting an HIC sample, wherein said HIC sample comprises said HCP-reduced antibody, or antigen-binding portion thereof, preparation. |
