S22 In vitro & in vivo ADME Considerations for Guiding Engineering of Next Generation of Protein Therapeutics

Josh T Pearson , Pharmacokinetics and Drug Metabolism, Amgen, South San Francisco, CA
The presentation will cover strategies and workflows for characterizing potential instabilities of dual targeting protein therapeutics during their in vivo trafficking. Combined with in vivo studies, in vitro assays to elucidate whether degradative events occur during systemic circulation versus at the site of action are necessary for understanding factors contributing to the observed in vivo PK/PD relationship. This information is essential to guide engineering and for preclinical to clinical translation.