Summary

The advent of biopharmaceuticals in current medicine brought enormous benefits to the treatment of life-threatening human diseases (e.g., cancer, diabetes and neurodegenerative disorders), and improved the well-being of many people worldwide. The global portfolio of these therapeutic products include proteins and antibodies, nucleic acids, and cell-based products, and continues to expand at a rapid pace - approvals in the period 2015-2018 essentially double the typical five-yearly historical approval pace (G. Walsh, Nat. Biotechnol., 36:1136-1145, 2018) -, representing a significant share of the entire market of pharmaceuticals.

Innovation in the (bio)pharmaceutical industry has been driven towards the development of cost-effective manufacturing processes, envisaging the delivery of products in high quantity, with superior quality (purity), and high specificity, with the ultimate goal of benefiting patients. Progress in this direction have resulted from the application of novel technologies in the upstream stage (high-throughput, single-use devices, statistical optimization of media and fermentation conditions, QbD, and continuous processing), while at the downstream level, chromatography has evolved through the development of new resins and ligands, coupled with advances in process modelling, operating and control strategies.

An emerging trend is the application of alternative solvents such as ionic liquids and deep eutectic solvents, in which their structure and physicochemical properties can be tuned to address unmet needs in (bio)pharmaceutical research. These compounds may be derived from natural and reneawable sources and hold great promise in the development of efficient, sustainable and cost-effective biopharmaceuticals purification processes.

This Entry Collection aims to provide the latest progresses achieved in pharmaceuticals bioprocessing. We welcome submissions of original research, comprehensive reviews and perspectives, including, but not limited, to the following fields:

- Upstream processing (genetic engineering, systems biology, difficult-to-express proteins, expression conditions, Quality by Design approaches, process analytical technologies);

- Chromatographic purification methods (process modelling and control, continuous bioprocessing, design and characterization of resins and ligands, new formats);

- Alternative purification methods (aqueous biphasic systems, filtration, crystallization, precipitation);

- Application of neoteric solvents in upstream and downstream stages;

- Analytical characterization of biopharmaceuticals (stability, post-translational modifications, biological activity, immunogenicity); 

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Entries
Topic Review
Monoclonal Antibodies for Acute Myeloid Leukemia/Myelodysplastic Syndromes
Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) represent an unmet clinical need whose prognosis is still dismal. Alterations of immune response play a prominent role in AML/MDS pathogenesis, revealing novel options for immunotherapy. Among immune system regulators, CD47, immune checkpoints, and toll-like receptor 2 (TLR2) are major targets. Magrolimab antagonizes CD47, which is overexpressed by AML and MDS cells, thus inducing macrophage phagocytosis with clinical activity in AML/MDS. Sabatolimab, an inhibitor of T-cell immunoglobulin and mucin domain-containing protein 3 (TIM3), which disrupts its binding to galectin-9, has shown promising results in AML/MDS, enhancing the effector functions of lymphocytes and triggering tumor cell death. Several other surface molecules, namely CD33, CD123, CD45, and CD70, can be targeted with monoclonal antibodies (mAbs) that exert different mechanisms of action and include naked and conjugated antibodies, bispecific T-cell engagers, trispecific killer engagers, and fusion proteins linked to toxins. 
  • 836
  • 20 Jul 2022
Topic Review
Molecular Biology of Toona sinensis
Toona sinensis belongs to the Meliaceae family and is commonly called Chinese toon or Chinese mahogany. Young leaves and buds of T. sinensis plants are excellent source of flavonoids, terpenoids, phenylpropanoids, and more. In addition, the bioactive components of T. sinensis possess numerous health benefits, such as antiviral, antioxidant, anti-cancer, anti-inflammatory, and hypoglycemic effects. 
  • 647
  • 19 Jul 2022
Topic Review
Nanoparticle- and Microparticle-Based Vaccines against Orbiviruses
Bluetongue virus (BTV) and African horse sickness virus (AHSV) are widespread arboviruses that cause important economic losses in the livestock and equine industries, respectively. In addition to these, another arthropod-transmitted orbivirus known as epizootic hemorrhagic disease virus (EHDV) entails a major threat as there is a conducive landscape that nurtures its emergence in non-endemic countries. To date, only vaccinations with live attenuated or inactivated vaccines permit the control of these three viral diseases, although important drawbacks, e.g., low safety profile and effectiveness, and lack of DIVA (differentiation of infected from vaccinated animals) properties, constrain their usage as prophylactic measures. Moreover, a substantial number of serotypes of BTV, AHSV and EHDV have been described, with poor induction of cross-protective immune responses among serotypes. In the context of next-generation vaccine development, antigen delivery systems based on nano- or microparticles have gathered significant attention. A diversity of technologies, such as virus-like particles or self-assembled protein complexes, have been implemented for vaccine design against these viruses.
  • 574
  • 19 Jul 2022
Topic Review
Biosensing Applications of PC-12 Cell Line
The immortalized PC-12 cell line demonstrated to be a classical neuronal cell model derived from rat pheochromocytoma with the ability to acquire the sympathetic neurons features in a differentiation process in the presence of nerve growth factor. PC-12 cell line was shown to be the preferred model in neurobiology study using biosensing devices. The analytical achievements and applicability of reported biosensing devices in PC-12 cultures for the detection of ions, neurotransmitters, and cellular events are summarized.
  • 390
  • 18 Jul 2022
Topic Review
PC-12 Cell Line
PC-12 cells have been widely used as a neuronal line study model in many biosensing devices, mainly due to the neurogenic characteristics acquired after differentiation, such as high level of secreted neurotransmitter, neuron morphology characterized by neurite outgrowth, and expression of ion and neurotransmitter receptors. 
  • 973
  • 18 Jul 2022
Topic Review
South African Medicinal Plants in Metabolic Disorders Management
Metabolic syndrome (MetS) is a prevalent, multifactorial and complex disease that is associated with an increased risk of developing diabetes and other major cardiovascular complications. The rise in the global prevalence of MetS has been attributed to genetic, epigenetic, and environmental factors. The adoption of sedentary lifestyles that are characterized by low physical activity and the consumption of high-energy diets contributes to MetS development. Current management criteria for MetS risk factors involve changes in lifestyle and the use of pharmacological agents that target specific biochemical pathways involved in the metabolism of nutrients. Pharmaceutical drugs are usually expensive and are associated with several undesirable side effects. Alternative management strategies of MetS risk factors involve the use of medicinal plants that are considered to have multiple therapeutic targets and are easily accessible. Medicinal plants contain several different biologically active compounds that provide health benefits.
  • 514
  • 18 Jul 2022
Topic Review
Monomers and Oligomers of Arrestin Proteins
Three out of four subtypes of arrestin proteins expressed in mammals self-associate, each forming oligomers of a distinct kind. Monomers and oligomers have different subcellular localization and distinct biological functions. Visual arrestin (a.k.a. S-antigen, 48 kDa protein, and rod arrestin; systematic name arrestin-1) is expressed in rod and cone photoreceptor cells in the retina, whereas arrestin-4 is expressed exclusively in cones at a much lower level than arrestin-1.
  • 403
  • 18 Jul 2022
Topic Review
Liver Metastatic Breast Cancer
The median overall survival of patients with metastatic breast cancer is only 2–3 years, and for patients with untreated liver metastasis, it is as short as 4–8 months. Improving the survival of women with breast cancer requires more effective anti-cancer strategies, especially for metastatic disease. Nutrients can influence tumor microenvironments, and cancer metabolism can be manipulated via dietary modification to enhance anti-cancer strategies. Yet, there are no standard evidence-based recommendations for diet therapies before or during cancer treatment, and few studies provide definitive data that certain diets can mediate tumor progression or therapeutic effectiveness in human cancer. This review focuses on metastatic breast cancer, in particular liver metastatic forms, and recent studies on the impact of diets on disease progression and treatment.
  • 685
  • 22 Jul 2022
Topic Review
Adiponectin System (Rescue Hormone)
The adipose tissue, regardless of its role in generating and storing energy, acts as a key player as an endocrine tissue, producing a wide scale of cytokines/hormones called adipokines. Adipokines such as leptin, resistin, visfatin and osteopontin own pro-inflammatory effects on the cardiovascular system in some cases. In contrast, some adipokines have cardioprotective and anti-inflammatory impacts including adiponectin, omentin, and apelin.
  • 535
  • 12 Jul 2022
Topic Review
Chitosan-Based Materials and Devices
Chitosan is one of the most studied polysaccharides in recent decades for its biomedical application. This polymer is derived from chitin, the main component in the exoskeleton of insects and crustaceans, a homopolymer consisting of β-(1→4)-N-acetyl-D-glucosamine. The degree of deacetylation of chitosan depends on the conditions applied during the deacetylation process—such as temperature or sodium hydroxide concentration—and determines various properties of the polymer, such as pKa, solubility, and viscosity. Chitosan has been used in a broad assortment of medical materials and devices. Each system benefits from the properties that chitosan can provide for surgical applications. The shape, porosity, consistency, and size of the fabricated systems can be precisely tuned for the intended application.
  • 519
  • 11 Jul 2022
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