Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing
Biopharmaceutical and pharmaceutical manufacturing are strongly influenced by the process analytical technology initiative (PAT) and quality by design (QbD) methodologies, which are designed to enhance the understanding of more integrated processes. The major aim of this effort can be summarized as...
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| Format: | Online |
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| Jezik: | engleski |
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2022
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| Online pristup: | ONIX_20220916_9783036552101_128 |
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| collection | Directory of Open Access Books |
| description | Biopharmaceutical and pharmaceutical manufacturing are strongly influenced by the process analytical technology initiative (PAT) and quality by design (QbD) methodologies, which are designed to enhance the understanding of more integrated processes. The major aim of this effort can be summarized as developing a mechanistic understanding of a wide range of process steps, including the development of technologies to perform online measurements and real-time control and optimization. Furthermore, minimization of the number of empirical experiments and the model-assisted exploration of the process design space are targeted. Even if tremendous progress has been achieved so far, there is still work to be carried out in order to realize the full potential of the process systems engineering toolbox. Within this reprint, an overview of cutting-edge developments of process systems engineering for biopharmaceutical and pharmaceutical manufacturing processes is given, including model-based process design, Digital Twins, computer-aided process understanding, process development and optimization, and monitoring and control of bioprocesses. The biopharmaceutical processes addressed focus on the manufacturing of biopharmaceuticals, mainly by Chinese hamster ovary (CHO) cells, as well as adeno-associated virus production and generation of cell spheroids for cell therapies. |
| format | Online |
| id | doab-20.500.12854ir-92142 |
| institution | Directory of Open Access Books |
| language | eng |
| publishDate | 2022 |
| publishDateRange | 2022 |
| publishDateSort | 2022 |
| record_format | ojs |
| spelling | doab-20.500.12854ir-921422024-04-11T15:10:27Z Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing Pörtner, Ralf Möller, Johannes clonal cell population phenotypic diversity inoculum train uncertainty-based cell culture model biopharmaceutical manufacturing Escherichia coli hybrid modeling machine learning model-assisted DoE quality by design upstream bioprocessing surface plasmon resonance (SPR) bioprocess monitoring biosensor quality by design (QbD) process analytical technology (PAT) biotherapeutics production vaccines production CHO DP-12 computational fluid dynamics bioreactor characterization hydrodynamic gradients process development critical shear stress Kolmogorov length scale operational space sensors cell culture spectroscopy PAT smart biomanufacturing soft-sensor Adeno-associated virus transfection PEI continuous gene therapy microcarriers bioreactor transient expression spheroid strength β-cells diabetes shear stress-guided production hydrodynamic stress Gaussian processes Bayes optimization Pareto optimization multi-objective seed train Chinese hamster ovary cells cryopreservation monoclonal antibodies N−1 perfusion process intensification upstream processing n/a thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues::TBX History of engineering and technology Biopharmaceutical and pharmaceutical manufacturing are strongly influenced by the process analytical technology initiative (PAT) and quality by design (QbD) methodologies, which are designed to enhance the understanding of more integrated processes. The major aim of this effort can be summarized as developing a mechanistic understanding of a wide range of process steps, including the development of technologies to perform online measurements and real-time control and optimization. Furthermore, minimization of the number of empirical experiments and the model-assisted exploration of the process design space are targeted. Even if tremendous progress has been achieved so far, there is still work to be carried out in order to realize the full potential of the process systems engineering toolbox. Within this reprint, an overview of cutting-edge developments of process systems engineering for biopharmaceutical and pharmaceutical manufacturing processes is given, including model-based process design, Digital Twins, computer-aided process understanding, process development and optimization, and monitoring and control of bioprocesses. The biopharmaceutical processes addressed focus on the manufacturing of biopharmaceuticals, mainly by Chinese hamster ovary (CHO) cells, as well as adeno-associated virus production and generation of cell spheroids for cell therapies. 2022-09-16T13:48:15Z 2022-09-16T13:48:15Z 2022 book ONIX_20220916_9783036552101_128 9783036552101 9783036552095 https://directory.doabooks.org/handle/20.500.12854/92142 eng application/octet-stream Attribution 4.0 International https://mdpi.com/books/pdfview/book/6019 https://mdpi.com/books/pdfview/book/6019 10.3390/books978-3-0365-5209-5 10.3390/books978-3-0365-5209-5 MDPI - Multidisciplinary Digital Publishing Institute 9783036552101 9783036552095 226 Basel open access |
| spellingShingle | clonal cell population phenotypic diversity inoculum train uncertainty-based cell culture model biopharmaceutical manufacturing Escherichia coli hybrid modeling machine learning model-assisted DoE quality by design upstream bioprocessing surface plasmon resonance (SPR) bioprocess monitoring biosensor quality by design (QbD) process analytical technology (PAT) biotherapeutics production vaccines production CHO DP-12 computational fluid dynamics bioreactor characterization hydrodynamic gradients process development critical shear stress Kolmogorov length scale operational space sensors cell culture spectroscopy PAT smart biomanufacturing soft-sensor Adeno-associated virus transfection PEI continuous gene therapy microcarriers bioreactor transient expression spheroid strength β-cells diabetes shear stress-guided production hydrodynamic stress Gaussian processes Bayes optimization Pareto optimization multi-objective seed train Chinese hamster ovary cells cryopreservation monoclonal antibodies N−1 perfusion process intensification upstream processing n/a thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues::TBX History of engineering and technology Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing |
| title | Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing |
| title_full | Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing |
| title_fullStr | Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing |
| title_full_unstemmed | Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing |
| title_short | Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing |
| title_sort | bioprocess systems engineering applications in pharmaceutical manufacturing |
| topic | clonal cell population phenotypic diversity inoculum train uncertainty-based cell culture model biopharmaceutical manufacturing Escherichia coli hybrid modeling machine learning model-assisted DoE quality by design upstream bioprocessing surface plasmon resonance (SPR) bioprocess monitoring biosensor quality by design (QbD) process analytical technology (PAT) biotherapeutics production vaccines production CHO DP-12 computational fluid dynamics bioreactor characterization hydrodynamic gradients process development critical shear stress Kolmogorov length scale operational space sensors cell culture spectroscopy PAT smart biomanufacturing soft-sensor Adeno-associated virus transfection PEI continuous gene therapy microcarriers bioreactor transient expression spheroid strength β-cells diabetes shear stress-guided production hydrodynamic stress Gaussian processes Bayes optimization Pareto optimization multi-objective seed train Chinese hamster ovary cells cryopreservation monoclonal antibodies N−1 perfusion process intensification upstream processing n/a thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues::TBX History of engineering and technology |
| topic_facet | clonal cell population phenotypic diversity inoculum train uncertainty-based cell culture model biopharmaceutical manufacturing Escherichia coli hybrid modeling machine learning model-assisted DoE quality by design upstream bioprocessing surface plasmon resonance (SPR) bioprocess monitoring biosensor quality by design (QbD) process analytical technology (PAT) biotherapeutics production vaccines production CHO DP-12 computational fluid dynamics bioreactor characterization hydrodynamic gradients process development critical shear stress Kolmogorov length scale operational space sensors cell culture spectroscopy PAT smart biomanufacturing soft-sensor Adeno-associated virus transfection PEI continuous gene therapy microcarriers bioreactor transient expression spheroid strength β-cells diabetes shear stress-guided production hydrodynamic stress Gaussian processes Bayes optimization Pareto optimization multi-objective seed train Chinese hamster ovary cells cryopreservation monoclonal antibodies N−1 perfusion process intensification upstream processing n/a thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues thema EDItEUR::T Technology, Engineering, Agriculture, Industrial processes::TB Technology: general issues::TBX History of engineering and technology |
| url | ONIX_20220916_9783036552101_128 |