US 2016/0083452 A1 · Isolation and Purification of Antibodies Using Protein A Affinity Chromatography

Abstract

Disclosed herein are methods for the isolation and purification of 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, preferably Protein A affinity, ion exchange chromatography, and hydrophobic chromatography. Further, the present invention is directed toward pharmaceutical compositions comprising one or more antibodies of the present invention.

Claims26

Dependent claims

A method for producing a host cell-protein (HCP) reduced antibody preparation from a sample mixture comprising an antibody and at least one HCP, said method comprising:

(a) subjecting said sample matrix to a reduction in pH thus forming a primary recovery sample, wherein said reduction in pH is from about 3 to about about 4;
(b) adjusting said primary recovery sample to a pH of about 6.0 to about 8 followed by contacting said primary recovery sample to an affinity chromatography resin and collecting an affinity chromatography sample;
(c) contacting said affinity chromatography sample to an ion exchange resin and collecting an ion exchange sample;
(d) contacting 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 preparation.

1 more element

Dependencies are inferred from the claim text.

Isolation and Purification of Antibodies Using Protein A Affinity Chromatography

Life of this patent

Isolation and Purification of Antibodies Using Protein A Affinity Chromatography

Life of this patent

Abstract

Claims26