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Perspective

Why Is Batch Processing Still Dominating the Biologics Landscape? Towards an Integrated Continuous Bioprocessing Alternative

1
Pharmaceutical Engineering Research Group (PharmaEng), Department of Pharmaceutical Analysis, Ghent University, 9000 Gent, Belgium
2
Process and Systems Engineering Center (PROSYS), Department of Chemical and Biochemical Engineering, Technical University of Denmark, 2800 Kongens Lyngby, Denmark
*
Author to whom correspondence should be addressed.
Processes 2020, 8(12), 1641; https://doi.org/10.3390/pr8121641
Received: 9 November 2020 / Revised: 4 December 2020 / Accepted: 10 December 2020 / Published: 12 December 2020
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. View Full-Text
Keywords: continuous manufacturing; bioprocessing; process systems engineering; single-use technology continuous manufacturing; bioprocessing; process systems engineering; single-use technology
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MDPI and ACS Style

Kumar, A.; Udugama, I.A.; Gargalo, C.L.; Gernaey, K.V. Why Is Batch Processing Still Dominating the Biologics Landscape? Towards an Integrated Continuous Bioprocessing Alternative. Processes 2020, 8, 1641. https://doi.org/10.3390/pr8121641

AMA Style

Kumar A, Udugama IA, Gargalo CL, Gernaey KV. Why Is Batch Processing Still Dominating the Biologics Landscape? Towards an Integrated Continuous Bioprocessing Alternative. Processes. 2020; 8(12):1641. https://doi.org/10.3390/pr8121641

Chicago/Turabian Style

Kumar, Ashish, Isuru A. Udugama, Carina L. Gargalo, and Krist V. Gernaey 2020. "Why Is Batch Processing Still Dominating the Biologics Landscape? Towards an Integrated Continuous Bioprocessing Alternative" Processes 8, no. 12: 1641. https://doi.org/10.3390/pr8121641

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