LAPSE:2024.0415
Published Article

LAPSE:2024.0415
Technoeconomic Analysis of Intensified PEGylated Biopharmaceutical Recombinant Protein Production: Alpha Antitrypsin as a Model Case
June 5, 2024
Alpha-1 antitrypsin deficiency (AATD) is a genetic disorder characterized by the insufficient production of the AAT protein. Due to availability limitations, not all AATD patients receive protein therapy treatment. In this study, the technoeconomic analysis of different processes (conventional and intensified) producing 200 kg/year of PEGylated recombinant AAT (PEG-AAT) using a Chinese hamster ovary cell line was investigated. All bioprocesses consist of upstream, downstream, and PEGylation sections. A base-case model (process A) of the conventional fed-batch production bioreactor was developed using SuperPro Designer software (Version 13) to evaluate the economic feasibility of the process. The cost of goods (COG) was estimated to be approximately USD 387.6/g. Furthermore, an intensified process (B) was modeled and evaluated to reduce the COG. Process intensification was implemented in the process (N-1 perfusion bioreactor). The specific operating COG for process B was found to be 10% less than that of process A. Scenario analysis was performed to assess the impact of process capacity (100−1000 kg/year) and cell-specific productivity (30−90 pg/cell/day). With an increase in process capacity, the specific operating COG was reduced for all processes. Increasing cell-specific productivity decreases the specific operating COG at different rates for each process, depending on the titer level. Future investigations into the PEGylation section are required since it has the highest COG of all the sections.
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Keywords
bioprocess engineering, Process Intensification, protein PEGylation, scenario analysis, Technoeconomic Analysis
Subject
Suggested Citation
Alkanaimsh S, Alsalal AM, El-Touney H. Technoeconomic Analysis of Intensified PEGylated Biopharmaceutical Recombinant Protein Production: Alpha Antitrypsin as a Model Case. (2024). LAPSE:2024.0415
Author Affiliations
Alkanaimsh S: Department of Chemical Engineering, College of Engineering and Petroleum, Kuwait University, P.O. Box 5969, Safat, Kuwait City 13060, Kuwait [ORCID]
Alsalal AM: Department of Chemical Engineering, College of Engineering and Petroleum, Kuwait University, P.O. Box 5969, Safat, Kuwait City 13060, Kuwait [ORCID]
El-Touney H: Department of Chemical Engineering, College of Engineering and Petroleum, Kuwait University, P.O. Box 5969, Safat, Kuwait City 13060, Kuwait
Alsalal AM: Department of Chemical Engineering, College of Engineering and Petroleum, Kuwait University, P.O. Box 5969, Safat, Kuwait City 13060, Kuwait [ORCID]
El-Touney H: Department of Chemical Engineering, College of Engineering and Petroleum, Kuwait University, P.O. Box 5969, Safat, Kuwait City 13060, Kuwait
Journal Name
Processes
Volume
12
Issue
5
First Page
979
Year
2024
Publication Date
2024-05-10
ISSN
2227-9717
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Original Submission
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PII: pr12050979, Publication Type: Journal Article
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LAPSE:2024.0415
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https://doi.org/10.3390/pr12050979
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Jun 5, 2024
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