Application of mass spectrometry to facilitate advanced process controls of biopharmaceutical manufacture

摘要

Development and implementation of process analytical technology and real-time release testing (here defined as advanced process controls) requires an approach to product development that emphasizes product and process understanding and process control, based on sound science and quality risk management (i.e., quality by design). Mathematical models can enhance the scientific understanding of a process and can also be explored for their predictive capability. Utilizing advanced process controls and mathematical models for biopharmaceutical products can be challenging given product/process complexity. Recent publications and preliminary work from our group are reviewed to show how the analytical capabilities of mass spectrometry can be leveraged to address these challenges.