Accelerating Biologics PBPK Modelling with Automated Model Building: A Tutorial.

Physiologically based pharmacokinetic (PBPK) modelling for biologics, such as monoclonal antibodies and therapeutic proteins, involves capturing complex processes, including target-mediated drug disposition (TMDD), FcRn-mediated recycling, and tissue-specific distribution. The Simcyp Designer Biologics PBPK Platform Model offers an intuitive and efficient platform for constructing mechanistic PBPK models with pre-defined templates and automated model assembly, reducing manual input and improving reproducibility. This tutorial provides a step-by-step guide to using the platform, highlighting features such as cross-species scaling, population variability simulations, and flexibility for model customization. Practical case studies demonstrate the platform's capability to streamline workflows, enabling rapid, mechanistic model development to address key questions in biologics drug development. By automating critical processes, this tool enhances decision-making in translational research, optimizing the modelling and simulation of large molecules across discovery and clinical stages.