With the increase in the use of biologic drugs, understanding absorption, distribution, metabolism and excretion (ADME) properties is critical to tuning the pharmacokinetic (PK) profiles of next generation biologics (NGBs). Knowledge of the fate of a drug is essential for the enhancement of the design processes, elongation of exposure at the desired site of action and achieving efficacy with minimum toxicity. In vivo proteolytic cleavage of biotherapeutics may lead to undesirable in vivo properties, such as rapid clearance, low bioavailability and loss of pharmacodynamic (PD) effect which may affect drug efficacy and/or generate safety concerns through increases in immunogenicity or off-target toxicity. Therefore, there is an urgent need for the biopharmaceutical industry to develop adequate bioanalytical methods for comprehensive biotransformation assessment of NGBs. In this work, we present an intact mass analysis using immunoaffinity purification (IA)-capillary electrophoresis-mass spectrometry (CE-MS) workflow to monitor biopharmaceuticals in vitro and in vivo stability.

Characterization of next generation biologics: in vitro and in vivo stability studies by intact mass analysis using immunoaffinity purification-capillary electrophoresis-mass spectrometry (IA-CE-MS) workflow

ACS Fall 2021

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