In Vivo Biotransformation
In context of Whole Blood Stability: ADC, in vivo biotransformation is a critical step to evaluate the stability of the protein/antibody/ADC in animal studies. For ADC, important information (e.g., payload metabolism, deconjugation) can be gained by in vivo biotransformation studies. For regular protein or antibody therapeutics, critical quality attributes such as PTM can be evaluated for in vivo biotransformation studies. Successful biotransformation study will provide information on blood/tissue distribution of ADC and catabolites, and on the pathway and rate of payload release. Taken together, biotransformation data enable intelligent screen, design and optimization of ADC conjugation scheme, selection of linker payload combination and chemistry.
At NovaBioAssays, we provide the workflow to evaluate in vivo biotransformation of Therapeutic protein/antibody/ADC. After immunoprecipitation of the analyte of interest from in vivo sample (serum or plasma), we perform either peptide mapping or intact mass analysis to characterize various properties of the analytes. We can evaluate DAR, PTM and metabolites with limited quantities of in vivo samples.