Biochemical assays for therapeutic proteins
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsMichael Partridge, Susan Irvin, Manoj Rajadhyaksha, Aynur Hermann
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Abstract
The present invention generally pertains to methods of testing the concentration of therapeutic proteins and testing for the presence of anti-drug antibodies (ADAs) against therapeutic proteins. In particular, the present invention pertains to the use of mitigating agents against interfering competing drugs in ligand binding assays or cell-based assays for the quantification of therapeutic proteins and detection of anti-drug antibodies and neutralizing antibodies against therapeutic proteins.
Claims31
A method for quantifying the concentration of a therapeutic protein in a sample, comprising:
- (a) contacting said sample having a competing drug to said therapeutic protein, a target of said therapeutic protein, a detection antibody, and a mitigating agent;
- and
- (b) measuring a binding of said therapeutic protein to said target to quantify the concentration of said therapeutic protein.
The method of claim 5, wherein said monoclonal antibody is selected from a group consisting of an anti-PD-1 antibody, an anti-TNF antibody, an anti-PD-L1 antibody, an anti-EGFR antibody, an anti-CD20 antibody, an anti-CD38 antibody, and an anti-LAG3 antibody.
A kit, comprising:
- (a) a therapeutic protein;
- (b) a target of said therapeutic protein;
- (c) a detection antibody;
- (d) a competing drug;
- and
- (e) a mitigating agent.
Dependencies are inferred from the claim text.