Model-Based Tools for Pharmaceutical Manufacturing Processes

Abstract

Active pharmaceutical ingredients (APIs) are highly valuable, highly sensitive products resulting from production processes with strict quality control specifications and regulations that are required for the safety of patients. To ensure a profitable and growing pharmaceutical industry of significant societal benefits and low environmental footprint, model-based tools are fundamental to advancing the basic understanding, design, and optimization of pharmaceutical manufacturing processes in accordance with the United Nations “2030 sustainable development goals”. Process analysis principles, for instance, provide a better understanding of underlying pharmaceutical manufacturing mechanisms. Model-based process design concepts facilitate the identification of optimal production and purification pathways and configurations. Process monitoring and control strategies ensure low life-cycle costs and provide new insights into critical failure modes and drug quality control issues. The foregoing model-based concepts, and combinations of them, are key to exploring the full potential of innovative, highly effective pharmaceutical manufacturing processes. These are some of the grand challenges that can be tackled by process systems engineering (PSE), and they have been catalyzed by an unprecedented advent of established methodologies and algorithmic tools that are either available via open access environments or incorporated in commercial software/databases for a plethora of purposes (thermodynamic and solubility modeling, fluid phase equilibria, complex mixture thermophysical/mechanical property estimation, plant-wide simulation, optimization and cost estimation). The respective advances achieved using such a diversity of enabling computational technologies exemplify the Quality-by-Design (QbD) vision and its translation into tangible artefacts and policies, illustrating how academia and industry respond to contemporary challenges for high-quality, more affordable healthcare. This Special Issue on “Model-Based Tools for Pharmaceutical Manufacturing Processes” intends to curate novel advances in the development and application of model-based tools to address ever-present challenges of the traditional pharmaceutical manufacturing practice as well as new trends. As summarized below, the Special Issue provides a collection of nine papers on original advances in the model-based process unit, system-level, QbD under uncertainty, and decision-making applications of pharmaceutical manufacturing processes. The Special Issue is available online at https://www.mdpi.com/journal/processes/special_issues/pharmaceutical_processes.