Abstract
In silico frameworks have the potential to improve experimentally designed processes for monoclonal antibody (mAb) manufacturing. In this paper, a framework for the analysis of mAb process alternatives is presented with the objective of realizing process improvements from a flowsheet perspective. The key elements of the proposed method include the generation and decomposition of the design space, the formulation of a flowsheet model, and the simulation and evaluation of alternative designs. An example of an evaluation of a new technology step in mAb manufacturing is given to demonstrate the application of the framework and to illustrate how the design problem is solved using the proposed step-by-step procedure. The methodical approach provides the opportunity to systematically and quantitatively evaluate the impact of different design decisions before selecting a final design. Therefore, it supports the finding of improved process designs that may be ignored using conventional experiment-based methods and sequential optimization of processing steps.
Original language | English |
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Journal | Chemical Engineering Research and Design |
Volume | 182 |
Pages (from-to) | 448-464 |
ISSN | 0263-8762 |
DOIs | |
Publication status | Published - 2022 |
Keywords
- In silico process design
- Flowsheet analysis
- Flowsheet model
- Discrete-event simulation
- Monoclonal antibody
- Capacity analysis