Methodology for fast development of digital solutions in integrated continuous downstream processing

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...

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Bibliographic Details
Published in:Biotechnology and bioengineering Vol. 121; no. 8; pp. 2378 - 2387
Main Authors: Andersson, Niklas, Fons, Joaquín Gomis, Isaksson, Madelène, Tallvod, Simon, Espinoza, Daniel, Sjökvist, Linnea, Andersson, Gusten Zandler, Nilsson, Bernt
Format: Journal Article
Language:English
Published: United States Wiley Subscription Services, Inc 01.08.2024
Subjects:
Analytical Chemistry
Analytisk kemi
Automation
batch‐to‐batch conttrol
Biological Products - metabolism
Biotechnology - methods
Chemical Sciences
continuous downstream processing
Continuous production
Control Engineering
Control equipment
Data analysis
digital twin
Digital twins
Electrical Engineering, Electronic Engineering, Information Engineering
Elektroteknik och elektronik
Engineering and Technology
Kalman filters
Kemi
Natural Sciences
Naturvetenskap
on‐line model‐based monitoring
Parallel operation
process automation
real‐time data analysis
Reglerteknik
Remote control
Remote monitoring
Software
Supervisory control
Teknik
Time synchronization
digital twin
continuous downstream processing
process automation
batch‐to‐batch conttrol
real‐time data analysis
on‐line model‐based monitoring
ISSN:0006-3592, 1097-0290, 1097-0290
Online Access:Get full text
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Summary: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 become 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 allows 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 implies 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.
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ISSN:0006-3592
1097-0290
1097-0290
DOI:10.1002/bit.28501