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PK assays for antibody-drug conjugates: case study with ado-trastuzumab emtansine
Ist Teil von
Bioanalysis, 2013-05, Vol.5 (9), p.1025-1040
Ort / Verlag
England
Erscheinungsjahr
2013
Link zum Volltext
Quelle
Taylor & Francis Journals Auto-Holdings Collection
Beschreibungen/Notizen
Antibody-drug conjugates (ADCs) combine the characteristics of large-molecule biologics and small-molecule drugs and are heterogeneous mixtures that can biotransform in vivo, resulting in additional complexity. ADC bioanalytical strategies require novel analytical methods, as well as existing large- and small-molecule methods. Because ADCs in late-stage clinical development are relatively new, regulatory guidelines and standard industry best practices for developing strategies for bioanalytical PK assays are still being established.
A PK assay strategy was developed that included comprehensive novel reagent and assay characterization approaches for the ADC ado-trastuzumab emtansine (T-DM1).
The bioanalytical strategy was successfully applied to the drug development of T-DM1 and ensured that key analytes were accurately measured in support of nonclinical and clinical development.