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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

Choose an application

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

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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Poly(lactic-co-glycolic acid) (PLGA) is one of the most successful polymers used for producing therapeutic devices, such as drug carriers (DC). PLGA is one of the few polymers that the Food and Drug Administration (FDA) has approved for human administration due to its biocompatibility and biodegradability. In recent years, DC produced with PLGA has gained enormous attention for its versatility in transporting different type of drugs, e.g., hydrophilic or hydrophobic small molecules, or macromolecules with a controlled drug release without modifying the physiochemical properties of the drugs. These drug delivery systems have the possibility/potential to modify their surface properties with functional groups, peptides, or other coatings to improve the interactions with biological materials. Furthermore, they present the possibility to be conjugated with specific target molecules to reach specific tissues or cells. They are also used for different therapeutic applications, such as in vaccinations, cancer treatment, neurological disorder treatment, and as anti-inflammatory agents. This book aims to focus on the recent progress of PLGA as a drug carrier and their new pharmaceutical applications.

PLGA --- nanoscaled drug delivery --- LED --- cancer --- serum stability --- reactive oxygen species --- cellular uptake --- terahertz spectroscopy --- microspheres --- drug delivery --- formulation development --- molecular mobility --- vitamin E --- tocopherol --- PLA --- core-shell nanoparticles --- controlled drug release --- BMP-2 --- PLGA nanoparticles --- Pluronic F68 --- oxaliplatin --- hydrogel --- intra-abdominal anti-adhesion barrier --- colorectal cancer --- experimental design --- fractional factorial design --- O6-methylguanine DNA methyltransferase (MGMT) protein --- glioblastoma multiforme --- smart nanocarriers --- folic acid --- verteporfin --- cisplatin --- SKOV-3 cells --- CHO-K1 cells --- electroporation --- theranostic cargo --- double emulsion approach --- NSAIDs --- polymeric film --- topical drug delivery --- trolamine salicylate --- triamcinolone acetonide --- microcrystal --- PLGA microsphere --- local delivery --- spray-drying technique --- intra-articular injection --- joint retention --- systemic exposure --- gadolinium --- drug release --- polymeric nanocarrier --- sorafenib --- theranostic nanoparticles --- PLGA-PEG --- nanoparticles --- platelet --- activation --- aggregation --- binding --- uptake --- tissue engineering --- Huntington’s disease --- siRNA --- microcarriers --- mesenchymal stromal cells --- drug delivery systems --- microfluidics --- microparticles --- BMP-2-microspheres --- hydrogel system --- 17-βestradiol release --- bone regeneration --- osteoporosis --- poly-lactide-co-glycolide --- polylactic acid --- alginate --- ophthalmic drug delivery --- dexamethasone --- PLGA-NPs --- nanomedicine --- gastrointestinal tract --- paclitaxel --- in vivo imaging --- controlled release --- risperidone --- microcapsules --- oleogels --- electron microscopy --- three-dimensional X-ray imaging --- nano-CT --- biodegradable polymers --- hydroxy-stearic acid --- PLGA nanocapsules --- magnetic resonance imaging --- photoluminescence --- magnetic targeting --- multimodal imaging --- theranostics --- silicon --- microsphere --- n/a --- Huntington's disease