loading page

Monitoring Product Quantity, Purity and Potency of Biopharmaceuticals in Real-time by Predictive Chemometrics and Soft sensors
  • Astrid Dürauer,
  • Alois Jungbauer,
  • Theresa Scharl
Astrid Dürauer
Universitat fur Bodenkultur Department fur Biotechnologie

Corresponding Author:[email protected]

Author Profile
Alois Jungbauer
Universitat fur Bodenkultur Department fur Biotechnologie
Author Profile
Theresa Scharl
Universitat fur Bodenkultur Wien Institut fur Statistik
Author Profile


The biopharmaceutical industry is still running in batch mode, mostly because it is a highly regulated industry sector. In the past, sensors were not readily available and in-process control was mainly executed off-line. The most important product parameters are quantity, purity and potency besides adventitious agents and bioburden. There is increasing economic pressure on time-to-market and also on the environmental sustainability of biopharmaceutical manufacturing. New concepts for manufacturing using disposable single-use technologies and integrated bioprocessing will dominate the future of bioprocessing. In order to ensure the quality of pharmaceuticals initiatives such as Process Analytical Technologies, Quality by Design and Continuous Integrated Manufacturing have been established. The vision must be that these initiatives together with technology development pave the way for process automation and autonomous bioprocessing without any human intervention. Then a real-time release would be realized leading to a highly predictive and robust biomanufacturing system. The steps toward such automated and autonomous bioprocessing are reviewed in context of monitoring and control. Starting from statistical treatment of single and multiple sensors, establishing soft sensors with predictive chemometrics and hybrid models. A scenario is described how to integrate soft sensors and predictive chemometrics into modern process control. This will be exemplified by selective downstream processing steps such as chromatography and membrane filtration, the most common unit operations for separation of biopharmaceuticals.
10 Mar 2023Submitted to Biotechnology and Bioengineering
16 Mar 2023Submission Checks Completed
16 Mar 2023Assigned to Editor
16 Mar 2023Review(s) Completed, Editorial Evaluation Pending
23 Apr 2023Reviewer(s) Assigned
19 May 2023Editorial Decision: Revise Major
13 Jun 20231st Revision Received
15 Jun 2023Submission Checks Completed
15 Jun 2023Assigned to Editor
15 Jun 2023Review(s) Completed, Editorial Evaluation Pending
07 Jul 2023Editorial Decision: Accept