ULTRAPURIFIED DsbA AND DsbC AND METHODS OF MAKING AND USING THE SAME
AssigneeGenentech, Inc.
InventorsMarc Wong, Liliana T. Yee, Amy Lim, Chris B. Fong
Life of this patent
Estimating the term…
Abstract
The present invention provides methods for producing disulfide oxidoreductase A (DsbA) and disulfide oxidoreductase C (DsbC) polypeptides at very high levels of purity. Also provided are ultrapure DsbA and DsbC and methods of using same, e.g., for use in immunoassays to show removal of DsbA and DsbC from biologics produced in bacteria.
Claims47
1-189. (canceled)
A method for quantifying disulfide oxidoreductase C (Dsb C) in a sample, comprising detecting DsbC in the sample using a detection system and comparing the amount of DsbC detected in the sample with the detection of one or more concentrations of an ultrapure DsbC reference standard.
A method for analyzing a recombinant polypeptide sample for the presence of and/or quantity of DsbC, comprising detecting DsbC in the sample using an immunoassay and comparing the amount of DsbC detected in the sample with the detection of one or more concentrations of an ultrapure DsbC reference standard.
200-203. (canceled)
(canceled)
207-210. (canceled)
213-214. (canceled)
An immunoassay method for detecting DsbC in a sample, wherein the sample is obtained from a recombinant polypeptide preparation or a host cell line, the method comprising:
- (a) contacting a capture antibody that binds DsbC with the sample thereby generating a sample-capture antibody combination material;
- (b) contacting a detection antibody that binds DsbC with the sample-capture antibody combination material;
- and
- (c) detecting the antibody bound to the sample-capture antibody combination material.
(canceled)
(canceled)
226-229.
231-232. (canceled)
235-236. (canceled)
(canceled)
247-255. (canceled)
Dependencies are inferred from the claim text.