04645nam 2201093z- 450 991059507280332120220916(CKB)5680000000080798(oapen)https://directory.doabooks.org/handle/20.500.12854/92142(oapen)doab92142(EXLCZ)99568000000008079820202209d2022 |y 0engurmn|---annantxtrdacontentcrdamediacrrdacarrierBioprocess Systems Engineering Applications in Pharmaceutical ManufacturingBasel20221 online resource (226 p.)3-0365-5210-3 3-0365-5209-X 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.History of engineering and technologybicsscTechnology: general issuesbicsscAdeno-associated virusBayes optimizationbiopharmaceutical manufacturingbioprocessbioreactorbioreactor characterizationbiosensorbiotherapeutics productioncell culturecell culture modelChinese hamster ovary cellsCHO DP-12clonal cell populationcomputational fluid dynamicscontinuouscritical shear stresscryopreservationdiabetesEscherichia coliGaussian processesgene therapyhybrid modelinghydrodynamic gradientshydrodynamic stressinoculum trainKolmogorov length scalemachine learningmicrocarriersmodel-assisted DoEmonitoringmonoclonal antibodiesmulti-objectiven/aN−1 perfusionoperational spacePareto optimizationPATPEIphenotypic diversityprocess analytical technology (PAT)process developmentprocess intensificationquality by designquality by design (QbD)seed trainsensorsshear stress-guided productionsmart biomanufacturingsoft-sensorspectroscopyspheroid strengthsurface plasmon resonance (SPR)transfectiontransient expressionuncertainty-basedupstream bioprocessingupstream processingvaccines productionβ-cellsHistory of engineering and technologyTechnology: general issuesPörtner Ralfedt1207271Möller JohannesedtPörtner RalfothMöller JohannesothBOOK9910595072803321Bioprocess Systems Engineering Applications in Pharmaceutical Manufacturing3033986UNINA