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
D-Serine and D-Aspartate in the Pathogenesis of Schizophrenia
Schizophrenia (Sch) is a severe and widespread mental disorder. Antipsychotics (APs) of the first and new generations as the first-line treatment of Sch are not effective in about a third of cases and are also unable to treat negative symptoms and cognitive deficits of schizophrenics. This explains the search for new therapeutic strategies for a disease-modifying therapy for treatment-resistant Sch (TRS). Biological compounds are of great interest to researchers and clinicians, among which D-Serine (D-Ser) and D-Aspartate (D-Asp) are among the promising ones. The Sch glutamate theory suggests that neurotransmission dysfunction caused by glutamate N-methyl-D-aspartate receptors (NMDARs) may represent a primary deficiency in this mental disorder and play an important role in the development of TRS. D-Ser and D-Asp are direct NMDAR agonists and may be involved in modulating the functional activity of dopaminergic neurons.
  • 644
  • 07 Dec 2022
Topic Review
Skeletal Effects of Naringenin
Various natural compounds can positively influence the skeletal remodelling process, of which naringenin is a candidate. Naringenin is an anti-inflammatory and antioxidant compound found in citrus fruits and grapefruit. 
  • 511
  • 07 Dec 2022
Topic Review
Biomedical Applications of Microfluidic Devices
Both passive and active microfluidic chips are used in many biomedical and chemical applications to support fluid mixing, particle manipulations, and signal detection. Passive microfluidic devices are geometry-dependent, and their uses are rather limited. Active microfluidic devices include sensors or detectors that transduce chemical, biological, and physical changes into electrical or optical signals. Also, they are transduction devices that detect biological and chemical changes in biomedical applications, and they are highly versatile microfluidic tools for disease diagnosis and organ modeling. Microfluidic devices are fabricated using a range of techniques, including molding, etching, three-dimensional printing, and nanofabrication. Their broad utility lies in the detection of diagnostic biomarkers and organ-on-chip approaches that permit disease modeling in cancer, as well as uses in neurological, cardiovascular, hepatic, and pulmonary diseases. Biosensor applications allow for point-of-care testing, using assays based on enzymes, nanozymes, antibodies, or nucleic acids (DNA or RNA). 
  • 697
  • 02 Dec 2022
Topic Review
Pap Smear Images Classification with Machine Learning
Cervical cancer is regularly diagnosed in women all over the world. This cancer is the seventh most frequent cancer globally and the fourth most prevalent cancer among women. Automated and higher accuracy of cervical cancer classification methods are needed for the early diagnosis of cancer. In addition, routine Pap smears could enhance clinical outcomes by facilitating the early diagnosis of cervical cancer. Liquid-based cytology (LBC)/Pap smears for advanced cervical screening is a highly effective precancerous cell detection technology based on cell image analysis, where cells are classed as normal or abnormal. Computer-aided systems in medical imaging have benefited greatly from extraordinary developments in artificial intelligence (AI) technology.
  • 547
  • 02 Dec 2022
Topic Review
Antimicrobial Properties of Plant Fibers
Healthcare-associated infections (HAI), or nosocomial infections, are a global health and economic problem in developed and developing countries, particularly for immunocompromised patients in their intensive care units (ICUs) and surgical site hospital areas. Recurrent pathogens in HAIs prevail over antibiotic-resistant bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. For this reason, natural antibacterial mechanisms are a viable alternative for HAI treatment. Natural fibers can inhibit bacterial growth, which can be considered a great advantage in these applications.
  • 524
  • 29 Nov 2022
Topic Review
Advancements in Noble Metal Nanoparticles-Based Point-of-Care Testing
Noble metal nanoparticles (NM NPs) have been used for POC testing for decades. The most known example might be the lateral flow assay (LFA, or test strip), where Au NPs are usually utilized as colorimetric labels owing to their outstanding optical properties. Over-the-counter pregnancy tests and the recent COVID-19 antigen rapid tests are representative examples of the lateral flow assays (LFA). Over the last couple of decades, engineered NM NPs have been extensively used for the point-of-care (POC) tests of various platforms beyond the LFA, despite most of them being in early stages of commercialization. This recent NM NPs-based POC testing techniques with innovative designs are discussed.
  • 431
  • 29 Nov 2022
Topic Review
Skeletal Muscle Gene Delivery
Since Jon A. Wolff found skeletal muscle cells being able to express foreign genes and Russell J. Mumper increased the gene transfection efficiency into the myocytes by adding polymers, skeletal muscles have become a potential gene delivery and expression target. Different methods have been developing to deliver transgene into skeletal muscles. Among them, viral vectors may achieve potent gene delivery efficiency. Therefore, non-viral biomaterial-mediated methods with reliable biocompatibility are promising tools for intramuscular gene delivery in situ. A series of advanced non-viral gene delivery materials and related methods have been reported, such as polymers, liposomes, cell penetrating peptides, as well as physical delivery methods.
  • 525
  • 25 Nov 2022
Topic Review
Types of Membrane Vesicles Acting as Tumor Vaccines
Membrane vesicles, a group of nano- or microsized vesicles, can be internalized or interact with the recipient cells, depending on their parental cells, size, structure and content. Membrane vesicles fuse with the target cell membrane, or they bind to the receptors on the cell surface, to transfer special effects. Based on versatile features, they can modulate the functions of immune cells and therefore influence immune responses. In the field of tumor therapeutic applications, phospholipid-membrane-based nanovesicles attract increased interest. Academic institutions and industrial companies are putting in effort to design, modify and apply membrane vesicles as potential tumor vaccines contributing to tumor immunotherapy. 
  • 433
  • 28 Nov 2022
Topic Review
Monocyte in the Tumor Microenvironment of Breast Cancer
Breast cancer (BC) is well-known for being a leading cause of death worldwide. It is classified molecularly into luminal A, luminal B HER2−, luminal B HER2+, HER2+, and triple-negative breast cancer (TNBC). These subtypes differ in their prognosis; thus, understanding the tumor microenvironment (TME) makes new treatment strategies possible. The TME contains populations that exhibit anti-tumorigenic actions such as tumor-associated eosinophils. Moreover, it contains pro-tumorigenic populations such as tumor-associated neutrophils (TANs), or monocyte-derived populations. The monocyte-derived populations are tumor-associated macrophages (TAMs) and MDSCs. Thus, a monocyte can be considered a maestro within the TME. 
  • 631
  • 24 Nov 2022
Topic Review
miR-21 in Kidney Injuries and Diseases
miR-21, one of the best-characterized miRNAs to date, has received much attention in renal physiology in particular given its high degree of conservation and expression in kidneys, as well as its potent pathogenic role in various debilitating renal diseases. In contrast with normal kidney function, miR-21 switches to a powerful and overactive mediator under stress conditions. In particular, miR-21 is one of the most highly upregulated miRNAs in a wide panel of tissue injuries, and may act as a cellular sensor of injuries that mediates tissue regeneration.
  • 447
  • 24 Nov 2022
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