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Methodology for fast development of digital solutions in integrated continuous downstream processing
  • +5
  • Bernt Nilsson,
  • Niklas Andersson,
  • Joaquín Gomis Fons,
  • Madelene Isaksson,
  • Simon Tallvod,
  • Daniel Espinoza,
  • Linnea Sjökvist,
  • Gusten Zandler Andersson
Bernt Nilsson
Lunds Universitet

Corresponding Author:[email protected]

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Niklas Andersson
Lunds Universitet
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Joaquín Gomis Fons
Lunds Universitet
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Madelene Isaksson
Lunds Universitet
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Simon Tallvod
Lunds Universitet
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Daniel Espinoza
Lunds Universitet
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Linnea Sjökvist
Lunds Universitet
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Gusten Zandler Andersson
Lunds Universitet
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Abstract

The methodology for production of biologics is going through a paradigm shift from batch-wise operation to continuous production. Lot of efforts are focused on integration, intensification and continuous operation for decreased foot-print, material, equipment and increased productivity and product quality. These integrated continuous processes with on-line analytics becomes complex processes, which requires automation, monitoring and control of the operation, even unmanned or remote, which means bioprocesses with high level of automation or even autonomous capabilities. The development of these digital solutions becomes an important part of the process development and needs to be assessed early in the development chain. This work discusses a platform that allow fast development, advanced studies and validation of digital solutions for integrated continuous downstream processes. It uses an open, flexible and extendable real-time supervisory controller, called Orbit, developed in Python. Orbit makes it possible to communicate with a set of different physical setups and on the same time perform real-time execution. Integrated continuous processing often imply parallel operation of several setups and network of Orbit controllers makes it possible to synchronize complex process system. Data handling, storage and analysis are important properties for handling heterogeneous and asynchronous data generated in complex downstream systems. Digital twin applications, such as advanced model-based and plant-wide monitoring and control, are exemplified using computational extensions in Orbit, exploiting data and models. Examples of novel digital solutions in integrated downstream processes are automatic operation parameter optimization, Kalman filter monitoring and model-based batch-to-batch control.
02 Feb 2023Submitted to Biotechnology and Bioengineering
08 Feb 2023Submission Checks Completed
08 Feb 2023Assigned to Editor
08 Feb 2023Review(s) Completed, Editorial Evaluation Pending
24 Feb 2023Reviewer(s) Assigned
23 Apr 2023Editorial Decision: Revise Major
01 Jun 20231st Revision Received
02 Jun 2023Submission Checks Completed
02 Jun 2023Assigned to Editor
02 Jun 2023Review(s) Completed, Editorial Evaluation Pending
07 Jul 2023Editorial Decision: Accept