Highly sensitive monoclonal antibody residual detection assay

Patent metadata

Field	Value
Publication number	US-8945860-B2
Application number	US-201113231280-A
Country	US
Kind code	B2
Filing date	Sep 13, 2011
Priority date	Sep 13, 2010
Publication date	Feb 3, 2015
Grant date	Feb 3, 2015

Abstract

The present invention relates to compositions and highly sensitive methods for the detection of biotechnology product residual when monitoring product carry over and/or for cleaning verification in the manufacture of biotechnology products. In particular, the present invention is directed to immunoassays wherein one or more capture antibodies, or antigen binding fragments thereof, are used to detect residuals associated with the production of biotechnology products.

First claim

What is claimed is:

1. A method for detecting an antibody product, or fragment thereof, the method comprising:
(a) contacting a test sample suspected of containing the antibody product or fragment thereof with a substrate comprising a mixture of five or more distinct classes of capture antibodies or antigen binding fragments thereof so as to form at least one capture antibody-antibody product complex;
wherein the five or more distinct classes of capture antibodies or antigen bin…

Assignees

• Yang Lihua
• Ramasubramanyan Natarajan
• Abbvie Inc

Inventors

• Yang Lihua
• Ramasubramanyan Natarajan

Classifications

• G01N33/6854

  Physics · mapped topic

• C07K16/42

  Chemistry & Metallurgy · mapped topic

• G01N33/53 Primary

  Physics · mapped topic