(74c) Systems-Based Pharmaceutics – an End-of-Decade Report

Systems-based Pharmaceutics (SbP) is a systems engineering methodology for the pharmaceutical industry that encompasses drug substance and drug product manufacturing, as well as in vivo drug performance. The approach aims to capture available relevant knowledge in the form of validated mathematical models. By integrating knowledge across the product lifecycle, SbP allows the quantification of the impact of critical process parameters and other decisions and environmental factors on the product’s critical quality attributes and the process key performance indicators.

This paper assesses the extent to which the above vision, originally formulated at the start of this decade, has been translated into reality. Aspects considered include the extent to which advances in scientific understanding have been incorporated into mathematical models that can be deployed in support of product and process design and process operations; the formal validation of these models; and the use of models in quantifying and managing the risk in model-based decisions, and in identifying practically important gaps in current knowledge. The paper also considers how current trends towards digitalization, and the associated advances in IT technologies, impact the SbP vision and its ongoing realization.