Ideally, generic PK or TK immunoassays for drug candidates belonging to different IgG subclasses should be compatible with common species used in pre-clinical studies. Given the wide analyte concentration range that may occur in serum samples from pre-clinical studies, the assay should also be easily adaptable to detect wide variations in sample analyte concentration. Low sample volume requirements are desirable to conserve limited samples from mouse models early in development.
In this poster, data from IgG subclasses using a generic PK assay kit compatible with Gyrolab platforms is presented. Data is shown supporting use of the kit in studies throughout early-stage and pre-clinical development of recombinant human antibodies of different IgG subclasses in different species.
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