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US 2017/0370906 A1Published application
Bioanalytical analysis of site-specific antibody drug conjugates
AssigneeGenentech, Inc.
InventorsMartine Darwish, Surinder Kaur, Dian Su, Keyang Xu
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Abstract
Methods to rapidly and accurately detect, characterize, measure, and quantify site-specific antibody drug conjugates, that may be present in pre-clinical animal biological samples, or human biological samples, including plasma/serum and tissue samples.
Claims24
A method of evaluating an antibody drug conjugate (ADC) comprising:
- a. digesting an ADC comprising at least one drug moiety linked to an antibody at a recombinantly-engineered site selected from:
- a cysteine amino acid residue,
- a selenocysteine amino acid residue,
- a glutamine amino acid residue,
- a non-naturally occurring amino acid residue, and
- a sugar-modified glycan residue,
- with a protease that cleaves the ADC, to 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;
- and,
- b. analyzing the digested ADC composition by high performance liquid chromatography (HPLC) and/or mass spectrometry (MS) to detect at least one peptide fragment that is not linked to the at least one drug moiety.
6 more elements
Dependencies are inferred from the claim text.