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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Pörtner, Ralf edt Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing Basel MDPI Books 2022 1 electronic resource (226 p.) text txt rdacontent computer c rdamedia online resource cr rdacarrier Open access Unrestricted online access star 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. English Technology: general issues bicssc History of engineering & technology bicssc 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 3-0365-5210-3 3-0365-5209-X Möller, Johannes edt Pörtner, Ralf oth Möller, Johannes oth |
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English |
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Möller, Johannes Pörtner, Ralf Möller, Johannes |
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Möller, Johannes Pörtner, Ralf Möller, Johannes |
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HerausgeberIn Sonstige Sonstige |
title |
Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing |
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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_auth |
Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing |
title_new |
Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing |
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bioprocess systems engineering applications in pharmaceutical manufacturing |
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MDPI Books |
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2022 |
physical |
1 electronic resource (226 p.) |
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3-0365-5210-3 3-0365-5209-X |
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Not Illustrated |
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AT portnerralf bioprocesssystemsengineeringapplicationsinpharmaceuticalmanufacturing AT mollerjohannes bioprocesssystemsengineeringapplicationsinpharmaceuticalmanufacturing |
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(CKB)5680000000080798 (oapen)https://directory.doabooks.org/handle/20.500.12854/92142 (EXLCZ)995680000000080798 |
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Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing |
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