（キャンセルとなりました）第344回化学システム工学専攻公開セミナー Digitalization platform and supervisory control for continuous integrated manufacture of monoclonal antibodies
- 2019年9月19日(木) 10:30-12:00
|講演題目||Digitalization platform and supervisory control for continuous integrated manufacture of monoclonal antibodies|
|講演者||Prof. Massimo Morbidelli
Department of Chemistry, Materials and Chemical Engineering Politecnico di Milano, Milano, Italy and Department of Chemistry and Applied Biosciences ETH Zurich, Zurich, Switzerland
|概要||In the last years, there has been an increased interest in continuous and integrated manufacturing of biopharmaceuticals, due to increasing cost and time pressure in industry as well as diversifying pipelines asking for more flexible production concepts. However, we are still far from an efficient implementation of modern process analyzers, a centralized data mining combined with online use of advanced analysis algorithms and the integration of process knowledge into a supervisory control frame.
In this contribution, we present an automated end-to-end integrated platform for the production of a monoclonal antibody. The process consists of a perfusion bioreactor, a continuous protein A capture step, which is followed by low-pH virus inactivation, and frontal and flow-through chromatographic steps for final polishing. Automated at-line HPLC systems equipped with protein A and size exclusion columns give insight into critical process parameters without the necessity of manual sampling. Additionally, the potential of Raman spectroscopy was investigated in USP and a flow cell was developed to enable important real-time information from downstream units.
The presented results will show the need for an efficient process data collection and hierarchical control system to handle process perturbations and drifts, facilitating robust product yield and quality. The presented concept provides a very important basis to intensify the main advantages of continuous integrated manufacturing in agreement with the trends of industry 4.0.