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Current challenges and recent advances on the path towards continuous biomanufacturing

Published

Author(s)

Boonserm Kulvatunyou, Milos Drobnjakovic, Nenad Ivezic, Vijay Srinivasan, Roger Hart

Abstract

Continuous biopharmaceutical manufacturing is currently a field of intense research due to its potential to make the entire production process more optimal for the modern, ever-evolving biopharmaceutical market. Compared to traditional batch manufacturing, continuous bioprocessing is more efficient, adjustable, and sustainable and has reduced capital costs. However, despite its clear advantages, continuous bioprocessing is yet to be widely adopted in commercial manufacturing. This paper gives a review of the technological and organizational roadblocks for extensive adoptions and points out the recent advances that could help overcome them. In total, three key areas for improvement are identified: Quality by Design (QbD) implementation, integration of upstream and downstream technologies, and data and knowledge management. First, the challenges to QbD implementation are explored. Specifically, process control, process analytical technology (PAT), media formulation, critical process parameter (CPP) identification, and mathematical models for bioprocess control and design are recognized as crucial for successful QbD realizations. Next, the difficulties of end-to-end process integration are examined, with a particular emphasis on downstream processing. Finally, the problem of data and knowledge management and its potential solutions are outlined where ontologies and data standards are pointed out as key drivers of progress.
Citation
Biotechnology Progress

Keywords

continuous biomanufacturing, process intensification, Quality by Design, process integration, knowledge management, process analytical technology, process modeling

Citation

Kulvatunyou, B. , Drobnjakovic, M. , Ivezic, N. , Srinivasan, V. and Hart, R. (2023), Current challenges and recent advances on the path towards continuous biomanufacturing, Biotechnology Progress, [online], https://doi.org/10.1002/btpr.3378, https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=935066 (Accessed March 1, 2024)
Created June 21, 2023, Updated November 27, 2023