Patent ID: 9580506
Date: 2017-02-28
CPC Classifications: C07K,G01N

Claim:
1. A method for analyzing and selecting at least one batch of a drug product, wherein the batch comprises an antibody or antibody fragment having an Fc receptor (FcR)-binding moiety, and wherein at least one mechanism of action of the antibody or antibody fragment of the drug product is mediated through the binding of the antibody or antibody fragment of the drug product to an Fc receptor, the method comprising the steps of: (a) providing an antibody or antibody fragment of the drug product and a reference standard antibody or antibody fragment, (b) contacting the antibody or antibody fragment of the drug product with an FcγRIII receptor, wherein the FcγRIII receptor has been modified such that it has a reduced amount of sialic acid on the N-linked glycosylation as compared to the same FcγRIII receptor in unmodified form, (c) contacting the reference standard to the FcγRIII receptor, (d) measuring the binding of the antibody or antibody fragment to the FcγRIII receptor, (e) measuring the binding of the reference standard to the FcγRIII receptor, (f) comparing the FcR binding of the antibody or antibody fragment to the FcR binding of the reference standard, and (g) selecting the antibody or antibody fragment that has equal to or greater binding to the FcγRIII receptor compared to the reference standard, wherein the reference standard and the antibody or antibody fragment of the drug product are two different batches of the same antibody or antibody fragment.