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US 12,007,398 B2Granted
Cell-based assay for detecting anti-CD3 homodimers
AssigneeGenentech, Inc.
InventorKendall Carey
Life of this patent
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Abstract
The present invention provides a cell-based assay for identifying and/or quantifying anti-CD3 homodimers in a composition comprising a T cell-dependent Bispecific antibody (TDB). In some aspects, the invention T cells comprising a T cell activation responsive reporter are contacted with the TDB to detect the presence of anti-CD3 homodimers. Compositions of reporter T cells and kits are also contemplated.
Claims10
A method for quantitating an amount of anti-CD3 homodimer antibody in a composition comprising a T cell dependent bispecific antibody (TDB), the method comprising:
- (a) contacting a population of T cells with the composition at one or more concentrations of the TDB, wherein:
- (i) the population of T cells comprise a nucleic acid encoding a reporter operably linked to a response element that is responsive to T cell activation, and wherein expression of the reporter indicates the presence of anti-CD3 homodimer antibodies,
- (ii) the TDB comprises a target antigen binding fragment and a CD3 binding fragment, and
- (iii) the population of T cells does not comprise the target antigen;
- and
- (b) quantitating the amount of anti-CD3 homodimer antibody in the composition by correlating the expression of the reporter as a function of anti-CD3 homodimer antibody concentration in the composition using a standard curve, wherein the standard curve is generated by contacting T cells comprising the nucleic acid with different concentrations of a purified anti-CD3 homodimer antibody.
3 more elements
Dependencies are inferred from the claim text.