MAGNUS WETTERHALL
Global Marketing Manager – Bioprocessing, Waters Corporation, Sweden

Abstract

There is a strong drive to explore and implement new tools for process analytical technology (PAT) in biopharmaceutical drug development and manufacturing. Their implementation facilitates real time monitoring and control of critical quality attributes (CQAs) and critical process parameters (CPPs) throughout the discovery, development, and manufacturing of biologics. Having access to high performing and comprehensive analytics render in better process understanding, improved operational robustness and reduced risk of costly batch failures. Streamlined and easy-to-use instrumentation for liquid chromatography (LC) and mass spectrometry (MS) allow bioprocess engineers to take control of cell culturing and process developments with their own high-quality and high-confidence data without being an MS expert.

The interest in exploring new tools for process analytical technology (PAT) in biopharmaceutical drug development and manufacturing is strong throughout the industry. However, despite the concept being well accepted and supported for almost two decades, the adoption of PAT in manufacturing settings is slower than first anticipated.

The purpose of PATs is to monitor and control a process based on measurable critical process parameters (CPPs) and the product›s critical quality attributes (CQAs). The goal is not to have to test the quality of the final product; this should be built into the process through a quality-by-design (QBD) approach that facilitates real-time monitoring and release.

Their implementation supports increased manufacturing efficiency, reduces waste and cost, speeds up the time to market, and enables intensified and continuous bioprocessing through integrated real-time monitoring and product release.

A complete process understanding where the critical sources of variation are known and controlled will enable the prediction of CQAs, increasing manufacturing efficiency and extending patient safety. In ...