LEADER 04645nam 2201093z- 450 001 9910595072803321 005 20220916 035 $a(CKB)5680000000080798 035 $a(oapen)https://directory.doabooks.org/handle/20.500.12854/92142 035 $a(oapen)doab92142 035 $a(EXLCZ)995680000000080798 100 $a20202209d2022 |y 0 101 0 $aeng 135 $aurmn|---annan 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aBioprocess Systems Engineering Applications in Pharmaceutical Manufacturing 210 $aBasel$d2022 215 $a1 online resource (226 p.) 311 08$a3-0365-5210-3 311 08$a3-0365-5209-X 330 $aBiopharmaceutical 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. 606 $aHistory of engineering and technology$2bicssc 606 $aTechnology: general issues$2bicssc 610 $aAdeno-associated virus 610 $aBayes optimization 610 $abiopharmaceutical manufacturing 610 $abioprocess 610 $abioreactor 610 $abioreactor characterization 610 $abiosensor 610 $abiotherapeutics production 610 $acell culture 610 $acell culture model 610 $aChinese hamster ovary cells 610 $aCHO DP-12 610 $aclonal cell population 610 $acomputational fluid dynamics 610 $acontinuous 610 $acritical shear stress 610 $acryopreservation 610 $adiabetes 610 $aEscherichia coli 610 $aGaussian processes 610 $agene therapy 610 $ahybrid modeling 610 $ahydrodynamic gradients 610 $ahydrodynamic stress 610 $ainoculum train 610 $aKolmogorov length scale 610 $amachine learning 610 $amicrocarriers 610 $amodel-assisted DoE 610 $amonitoring 610 $amonoclonal antibodies 610 $amulti-objective 610 $an/a 610 $aN?1 perfusion 610 $aoperational space 610 $aPareto optimization 610 $aPAT 610 $aPEI 610 $aphenotypic diversity 610 $aprocess analytical technology (PAT) 610 $aprocess development 610 $aprocess intensification 610 $aquality by design 610 $aquality by design (QbD) 610 $aseed train 610 $asensors 610 $ashear stress-guided production 610 $asmart biomanufacturing 610 $asoft-sensor 610 $aspectroscopy 610 $aspheroid strength 610 $asurface plasmon resonance (SPR) 610 $atransfection 610 $atransient expression 610 $auncertainty-based 610 $aupstream bioprocessing 610 $aupstream processing 610 $avaccines production 610 $a?-cells 615 7$aHistory of engineering and technology 615 7$aTechnology: general issues 700 $aPo?rtner$b Ralf$4edt$01207271 702 $aMo?ller$b Johannes$4edt 702 $aPo?rtner$b Ralf$4oth 702 $aMo?ller$b Johannes$4oth 906 $aBOOK 912 $a9910595072803321 996 $aBioprocess Systems Engineering Applications in Pharmaceutical Manufacturing$93033986 997 $aUNINA