TY - BOOK ID - 138941869 TI - Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing AU - Pörtner, Ralf AU - Möller, Johannes PY - 2022 PB - Basel MDPI Books DB - UniCat KW - clonal cell population KW - phenotypic diversity KW - inoculum train KW - uncertainty-based KW - cell culture model KW - biopharmaceutical manufacturing KW - Escherichia coli KW - hybrid modeling KW - machine learning KW - model-assisted DoE KW - quality by design KW - upstream bioprocessing KW - surface plasmon resonance (SPR) KW - bioprocess KW - monitoring KW - biosensor KW - quality by design (QbD) KW - process analytical technology (PAT) KW - biotherapeutics production KW - vaccines production KW - CHO DP-12 KW - computational fluid dynamics KW - bioreactor characterization KW - hydrodynamic gradients KW - process development KW - critical shear stress KW - Kolmogorov length scale KW - operational space KW - sensors KW - cell culture KW - spectroscopy KW - PAT KW - smart biomanufacturing KW - soft-sensor KW - Adeno-associated virus KW - transfection KW - PEI KW - continuous KW - gene therapy KW - microcarriers KW - bioreactor KW - transient expression KW - spheroid strength KW - β-cells KW - diabetes KW - shear stress-guided production KW - hydrodynamic stress KW - Gaussian processes KW - Bayes optimization KW - Pareto optimization KW - multi-objective KW - seed train KW - Chinese hamster ovary cells KW - cryopreservation KW - monoclonal antibodies KW - N−1 perfusion KW - process intensification KW - upstream processing KW - n/a UR - https://www.unicat.be/uniCat?func=search&query=sysid:138941869 AB - 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. ER -