LAPSE:2021.0647
Published Article
LAPSE:2021.0647
Why Is Batch Processing Still Dominating the Biologics Landscape? Towards an Integrated Continuous Bioprocessing Alternative
Ashish Kumar, Isuru A. Udugama, Carina L. Gargalo, Krist V. Gernaey
July 28, 2021
Continuous manufacturing of biologics (biopharmaceuticals) has been an area of active research and development for many reasons, ranging from the demand for operational streamlining to the requirement of achieving obvious economic benefits. At the same time, biopharma strives to develop systems and concepts that can operate at similar scales for clinical and commercial production—using flexible infrastructures, such as single-use flow paths and small surge vessels. These developments should simplify technology transfer, reduce footprint and capital investment, and will allow to react readily to changing market pressures while maintaining quality attributes. Despite a number of clearly identified benefits compared to traditional batch processes, continuous bioprocessing is still not widely adopted for commercial manufacturing. This paper details how industry-specific technological, organizational, economic, and regulatory barriers that exist in biopharmaceutical manufacturing are hindering the adoption of continuous production processes. Based on this understanding, the roles of process systems engineering (PSE), process analytical technologies, and process modeling and simulation are highlighted as key enabling tools in overcoming these multi-faceted barriers in today’s manufacturing environment. Of course, we do recognize that there is also a need for a clear set of regulations to guide a transition of biologics manufacturing towards continuous processing. Furthermore, the role played by the emerging fields of process integration and automation as well as digitalization is explored, as these are the tools of the future to facilitate this transition from batch to continuous production. Finally, an outlook focusing on technology, management, and regulatory aspects is presented to identify key concerted efforts required to drive the broad adaptation of continuous manufacturing in biopharmaceutical processes.
Keywords
bioprocessing, continuous manufacturing, process systems engineering, single-use technology
Subject
Suggested Citation
Kumar A, Udugama IA, Gargalo CL, Gernaey KV. Why Is Batch Processing Still Dominating the Biologics Landscape? Towards an Integrated Continuous Bioprocessing Alternative. (2021). LAPSE:2021.0647
Author Affiliations
Kumar A: Pharmaceutical Engineering Research Group (PharmaEng), Department of Pharmaceutical Analysis, Ghent University, 9000 Gent, Belgium [ORCID]
Udugama IA: Process and Systems Engineering Center (PROSYS), Department of Chemical and Biochemical Engineering, Technical University of Denmark, 2800 Kongens Lyngby, Denmark
Gargalo CL: Process and Systems Engineering Center (PROSYS), Department of Chemical and Biochemical Engineering, Technical University of Denmark, 2800 Kongens Lyngby, Denmark
Gernaey KV: Process and Systems Engineering Center (PROSYS), Department of Chemical and Biochemical Engineering, Technical University of Denmark, 2800 Kongens Lyngby, Denmark [ORCID]
Journal Name
Processes
Volume
8
Issue
12
Article Number
E1641
Year
2020
Publication Date
2020-12-12
Published Version
ISSN
2227-9717
Version Comments
Original Submission
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PII: pr8121641, Publication Type: Journal Article
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LAPSE:2021.0647
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doi:10.3390/pr8121641
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Jul 28, 2021
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CC BY 4.0
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Jul 28, 2021
 
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Calvin Tsay
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