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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.

Technology: general issues --- History of engineering & technology --- 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 --- 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

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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.

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

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Research & information: general --- vaccine --- adjuvants --- Sporothrix schenckii --- toluene --- virulence --- enolase --- Montanide PetGel A --- Amphotericin B --- cutaneous leishmaniasis --- hydrogel --- wound dressing --- controlled release --- thermoreversible gel --- poloxamer 407 --- candidiasis --- amphotericin B --- skin and vaginal mucosa --- butenafine --- SNEDDS --- solid SNEDDS --- spray drying --- leishmaniasis --- design of experiments --- orodispersible films --- fast-dissolving films --- micelles --- fungal infections --- aspergillosis --- oral delivery --- chitosan --- shiitake --- Lentinula edodes --- AHCC® --- Molecular Envelope Technology --- praziquantel --- calcium carbonate --- schistosomiasis --- bioavailability --- solubility --- cytotoxicity --- fluconazole --- orthopedic infection --- Poly(d,l-lactide-co-glycolide) beads --- sustained release --- Leishmania infantum --- meglumine antimoniate --- Sepigel 305® --- topical treatment --- polymer micelles --- drug delivery --- liposomes --- transferosomes --- nanoparticles --- emulsions --- azoles --- combined therapy --- quality by design --- malaria --- trypanosomiasis

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vaccine --- adjuvants --- Sporothrix schenckii --- toluene --- virulence --- enolase --- Montanide PetGel A --- Amphotericin B --- cutaneous leishmaniasis --- hydrogel --- wound dressing --- controlled release --- thermoreversible gel --- poloxamer 407 --- candidiasis --- amphotericin B --- skin and vaginal mucosa --- butenafine --- SNEDDS --- solid SNEDDS --- spray drying --- leishmaniasis --- design of experiments --- orodispersible films --- fast-dissolving films --- micelles --- fungal infections --- aspergillosis --- oral delivery --- chitosan --- shiitake --- Lentinula edodes --- AHCC® --- Molecular Envelope Technology --- praziquantel --- calcium carbonate --- schistosomiasis --- bioavailability --- solubility --- cytotoxicity --- fluconazole --- orthopedic infection --- Poly(d,l-lactide-co-glycolide) beads --- sustained release --- Leishmania infantum --- meglumine antimoniate --- Sepigel 305® --- topical treatment --- polymer micelles --- drug delivery --- liposomes --- transferosomes --- nanoparticles --- emulsions --- azoles --- combined therapy --- quality by design --- malaria --- trypanosomiasis

Choose an application

• Reference Manager
• EndNote
• RefWorks (Direct export to RefWorks)

undefined

Research & information: general --- vaccine --- adjuvants --- Sporothrix schenckii --- toluene --- virulence --- enolase --- Montanide PetGel A --- Amphotericin B --- cutaneous leishmaniasis --- hydrogel --- wound dressing --- controlled release --- thermoreversible gel --- poloxamer 407 --- candidiasis --- amphotericin B --- skin and vaginal mucosa --- butenafine --- SNEDDS --- solid SNEDDS --- spray drying --- leishmaniasis --- design of experiments --- orodispersible films --- fast-dissolving films --- micelles --- fungal infections --- aspergillosis --- oral delivery --- chitosan --- shiitake --- Lentinula edodes --- AHCC® --- Molecular Envelope Technology --- praziquantel --- calcium carbonate --- schistosomiasis --- bioavailability --- solubility --- cytotoxicity --- fluconazole --- orthopedic infection --- Poly(d,l-lactide-co-glycolide) beads --- sustained release --- Leishmania infantum --- meglumine antimoniate --- Sepigel 305® --- topical treatment --- polymer micelles --- drug delivery --- liposomes --- transferosomes --- nanoparticles --- emulsions --- azoles --- combined therapy --- quality by design --- malaria --- trypanosomiasis --- vaccine --- adjuvants --- Sporothrix schenckii --- toluene --- virulence --- enolase --- Montanide PetGel A --- Amphotericin B --- cutaneous leishmaniasis --- hydrogel --- wound dressing --- controlled release --- thermoreversible gel --- poloxamer 407 --- candidiasis --- amphotericin B --- skin and vaginal mucosa --- butenafine --- SNEDDS --- solid SNEDDS --- spray drying --- leishmaniasis --- design of experiments --- orodispersible films --- fast-dissolving films --- micelles --- fungal infections --- aspergillosis --- oral delivery --- chitosan --- shiitake --- Lentinula edodes --- AHCC® --- Molecular Envelope Technology --- praziquantel --- calcium carbonate --- schistosomiasis --- bioavailability --- solubility --- cytotoxicity --- fluconazole --- orthopedic infection --- Poly(d,l-lactide-co-glycolide) beads --- sustained release --- Leishmania infantum --- meglumine antimoniate --- Sepigel 305® --- topical treatment --- polymer micelles --- drug delivery --- liposomes --- transferosomes --- nanoparticles --- emulsions --- azoles --- combined therapy --- quality by design --- malaria --- trypanosomiasis