Patent ID: 11860156
Assignee: GENENTECH, INC.
Field: Measurement (Instruments)
Classification: CPC G  A  C | IPC A  C  G

Claim 0:
1. A method to detect and quantify antibody protein concentration and antibody-conjugated drug quantity in an antibody drug conjugate (ADC) comprising:
a. digesting the ADC bound via the Fab region to a target antigen-paramagnetic bead capture media, where the ADC comprises at least one drug moiety linked to an antibody at a recombinantly-engineered site cysteine amino acid residue in the Fab region with IdeS protease that cleaves the ADC, to remove the Fc fragment and form a digested ADC composition comprising at least one peptide fragment that is not linked to the at least one drug moiety, and at least one peptide fragment that is linked to the at least one drug moiety, wherein the digesting comprises incubating the ADC with the IdeS protease for a time period of 1 hour; and,
b. analyzing the digested ADC composition by a method comprising electrospray ionization liquid chromatography mass spectrometry.