Viral inactivation during purification of antibodies cross reference to related applications
AssigneeAbbVie Inc.
InventorsRobert K. Hickman, Ivan R. Correia
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Abstract
Described herein are methods for isolating and purifying antibodies from a sample matrix. One aspect of the present disclosure is directed to viral reduction/inactivation of samples generated in the various steps of antibody purification. In a particular aspect, methods herein employ an acidification step followed by one or more chromatography steps. The chromatography steps can include one or more of the following chromatographic procedures: ion exchange chromatography, affinity chromatography, and hydrophobic interaction chromatography.
Claims31
A method for producing a host cell-protein (HCP) reduced antibody preparation from a sample mixture comprising an antibody, an HCP and a viral particle, wherein the preparation comprises a decreased number of viral particles or decreased viral activity in comparison to the sample mixture, 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 to a pH of about 3 to about 5;
- (b) 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;
- (c) 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 preparation.
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 to about 3.5;
- (b) adjusting said primary recovery sample to a pH of about 5.0 followed by applying said primary recovery sample to a cation exchange resin and collecting a cation exchange sample;
- (c) applying said cation exchange sample to an anion exchange resin and collecting a anion exchange sample;
- and
- (d) applying said anion exchange sample to a hydrophobic interactive chromatography (HIC) resin and collecting an HIC sample, wherein said HIC sample comprises said HCP-reduced antibody preparation.
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 to about 3.5;
- (b) adjusting said primary recovery sample to a pH of about 5.0 followed by applying said primary recovery sample to a cation exchange resin and collecting a cation exchange sample;
- (c) subjecting said cation exchange sample to filtration and collecting a filtrate,
- (d) applying said filtrate from (c) to an anion exchange resin and collecting an anion exchange sample;
- and
- (e) applying said anion exchange sample to a hydrophobic interactive chromatography (HIC) resin and collecting an HIC sample, wherein said HIC sample comprises said HCP-reduced antibody preparation.
Dependencies are inferred from the claim text.