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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 --- n/a

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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 --- n/a

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A large number of diseases affect salivary gland (SG) secretion through different mechanisms, leading to SG dysfunction and associated oral problems. The glands may suffer from viral, bacterial, and, albeit rarely, fungal infections, which may cause painful swelling or obstruction; they could also become the target of an autoimmune attack or may be affected by various benign and malignant tumors which consist of a heterogeneous group of lesions with complex clinical–pathological characteristics. The loss of normal SG function results in widespread deterioration of oral health. This book, entitled “Diseases of Salivary Glands”, provides an overview of recent advances in the field of SG disorders, focusing on the cellular and molecular mechanisms involved in the pathogenesis of SG diseases and on the most innovative investigation techniques that could help to preserve patients’ health, function, and quality of life.

salivary glands --- minor salivary glands --- salivary gland carcinoma --- mucoepidermoid carcinoma --- in situ carcinoma --- intra-cystic carcinoma --- chronic kidney disease --- salivary gland dysfunction --- salivary biomarkers --- oxidative stress --- nitrosative stress --- viral infection --- Epstein-Barr virus --- HTLV-1 --- salivary gland epithelial cell --- Hashimoto’s disease --- saliva --- Sjögren’s syndrome --- autoimmune disease --- physiopathology --- treatment --- diagnosis --- review --- primary Sjögren’s syndrome --- imaging --- salivary gland --- sialography --- salivary gland ultrasonography --- magnetic resonance imaging --- sialendoscopy --- salivary gland scintigraphy --- positron emission tomography --- NF-κB --- inflammation --- autoimmunity --- innate cells --- adaptive cells --- MR sialography --- dynamic --- sublingual gland ducts --- xerostomia --- SGEC --- immortalization --- acinar --- ductal --- spheroid --- n/a --- autoimmune diseases --- Sjögren syndrome --- B-cell lymphoma --- extranodal marginal zone lymphoma --- MALT lymphoma --- primary breast lymphoma --- radiation --- hyposalivation --- purinergic signaling --- bystander effect --- P2 receptors --- radioprotection --- head and neck cancer --- oral candidiasis --- Hashimoto's disease --- Sjögren's syndrome --- primary Sjögren's syndrome --- Sjögren syndrome

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Canada continues to have a rich history of ground-breaking research in drug delivery within academic institutions, pharmaceutical industry and the biotechnology community.

encapsulation --- biodistribution --- pharmaceutics --- targeted therapies --- gambogic acid --- GE11 peptide --- formulation and dosage form development --- transient modulation --- ROESY NMR spectroscopy --- bioaccessibility --- polymeric micelle --- pharmacological Inhibitors of HIF-1 and STAT3 --- nanoparticles --- Vitamin D --- drug discovery --- EGFR-targeted therapy --- translational research --- clinical trials --- doxorubicin --- dissolution --- drug development --- permeation enhancers --- Canada --- plant --- primary central nervous system lymphomas --- photostabilizers --- head and neck squamous cell carcinoma --- mouse models --- drug delivery systems --- melphalan --- hypoxia-induced chemoresistance --- skin --- virus --- circadian clock --- child friendly formulation --- adenanthin --- co-delivery --- canola oil deodorizer distillate --- Metaplex --- innovation --- controlled drug delivery --- nifedipine --- radiolabeling --- amphotericin B --- biological barriers --- blood-brain barrier (BBB) --- biologicals --- lipid nanoparticles --- oral formulation --- phytosterols --- medical devices --- chronotherapy --- oral --- cationic gemini surfactant --- route of administration --- drug delivery --- intra-arterial chemotherapy --- developing world --- sustained delivery --- water miscible solvents --- combination therapy --- antibodies --- throughput --- magnetic fields --- liposomes --- medulloblastoma --- drug-resistant melanoma --- rosmarinic acid --- topical formulation --- TNO gastrointestinal model --- gastrointestinal simulator --- malignant gliomas --- transdermal drug delivery --- oral delivery --- precision medicine --- 3D spheroid --- flavonoids --- staurosporine --- DOX-Vit D --- loading gradients --- bacteriophage --- phospholipid complex --- triggered drug release --- HIF-1 --- phage display --- pharmacokinetics --- emulsion --- quercetin --- cisplatin --- parasitic infections --- remote loading --- HAV6 cadherin peptide --- blood-brain barrier --- inclusion complex --- tocopherols --- STAT3 --- ultrasound --- liposome --- fungal infections --- magnetic resonance imaging (MRI) --- MG63 --- model orange juice --- radiation --- cancer --- mefloquine --- small molecules --- Drug Delivery Systems --- Delivery systems, Drug --- Drug administration technology --- Drug delivery technology --- Drugs --- Pharmaceutical technology --- Delivery systems

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Adipose tissue is a rich, ubiquitous, and easily accessible source for multipotent mesenchymal stromal/stem cells (MSCs), so-called adipose-derived stromal/stem cells (ASCs). Primary isolated ASCs are a heterogeneous preparation consisting of several subpopulations of stromal/stem and precursor cells. Donor-specific differences in ASC isolations and the lack of culture standardization hinder the comparison of results from different studies. Nevertheless, ASCs are already being used in different in vivo models and clinical trials to investigate their ability to improve tissue and organ regeneration. Many questions concerning their counterparts and biology in situ, their differentiation potential in vitro and in vivo, and the mechanisms of regeneration (paracrine effects, including regeneration-promoting factors and extracellular vesicles, differentiation, and immunomodulation) are not completely understood or remain unanswered. This Special Issue covers research articles investigating various adipose tissues as a source for ASC isolation, specific cultures methods to enhance proliferation or viability, and the differentiation capacity. Furthermore, other studies highlight aspects of various diseases, the immunosuppressive potential of ASCs and their derivates, or the in vivo tracking of transplanted ASCs. This edition is complemented by a review that summarizes the current knowledge of spheroid culture system methods and applications for mesenchymal stem cells.

Medicine --- lipomas --- adipose tissue --- stem cells --- adipogenesis --- osteogenesis --- mesenchymal stem cells --- T-cells --- conditioned medium --- extracellular vesicles --- TLR --- INF-γ --- adipose-derived stromal cells --- equine metabolic syndrome --- metformin --- adipose-derived stem cells --- adipocytes --- differentiation --- collagen I --- adiponectin --- integrins --- discoidin domain-containing receptor --- ageing --- subcutaneous fat --- adipose tissue-derived mesenchymal stromal/stem cells (ASCs) --- cell differentiation --- volatile organic compounds --- metabolic monitoring --- adipose-derived stromal/stem cells --- chondrogenesis --- colony forming unit-fibroblast --- fetal bovine serum --- human platelet lysate --- mesenchymal stem cell --- regenerative medicine --- human adipose-derived stem cells --- stem cell proliferation --- signaling pathway --- adipose-derived mesenchymal stem cells --- migration --- secretion --- primary cilium --- sonic hedgehog signaling --- mesenchymal stromal/stem cells --- perirenal --- fat --- characterization --- stimulation --- lipopolysaccharide --- cytokines --- cytomegalovirus --- angiogenesis --- adipose derived mesenchymal cells --- Histogel --- 3D cell culture --- spheroid culture --- biomaterials --- phenotype --- secretory potential --- ankylosing spondylitis --- systemic lupus erythematosus --- systemic sclerosis --- mesenchymal stromal cells --- breast cancer --- tumor microenvironment --- perineural invasion --- adipose derived stem cells --- valproic acid --- protein interactions --- MAPK pathway --- JAK/STAT pathway --- mesenchymal stromal cell --- tissue of origin --- prolonged culture --- epigenetic memory --- tracking --- bio imaging --- bioluminescence --- qRT-PCR --- Ataxia telangiectasia --- Atm --- n/a