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
Ultrasonic Microbubble Cavitation in Tumor Therapy
Chemotherapy has an essential role not only in advanced solid tumor therapy intervention but also in society’s health at large. Chemoresistance, however, seriously restricts the efficiency and sensitivity of chemotherapeutic agents, representing a significant threat to patients’ quality of life and life expectancy. How to reverse chemoresistance, improve efficacy sensitization response, and reduce adverse side effects need to be tackled urgently. Consequently, studies on the effect of ultrasonic microbubble cavitation on enhanced permeability and retention (EPR) have attracted the attention of researchers. Compared with the traditional targeted drug delivery regimen, the microbubble cavitation effect, which can be used to enhance the EPR effect, has the advantages of less trauma, low cost, and good sensitization effect, and has significant application prospects.
  • 1.6K
  • 15 Aug 2022
Topic Review
Cancer Immunotherapy and Delivery System
Immunotherapy is a powerful clinical strategy for the treatment of various diseases, including cancer, and an understanding of cancer immunology is important to the optimization of this strategy to achieve higher efficacy. 
  • 1.3K
  • 15 Aug 2022
Topic Review
3D Bioprinting Skin and Melanoma Models
Melanoma is a potentially fatal cancer with rising incidence, associated with enhanced sun exposure and ultraviolet radiation. Its incidence is highest in people of European descent and the ageing population. Although survival has improved due to advances in targeted and immunotherapies, new understanding of melanoma biology and disease progression is vital to improving clinical outcomes. Efforts to develop three-dimensional human skin equivalent models using biofabrication techniques, such as bioprinting, promise to deliver a better understanding of the complexity of melanoma and associated risk factors. These 3D skin models can be used as a platform for patient specific models and testing therapeutics.
  • 1.2K
  • 11 Aug 2022
Topic Review
Representative Applications of Conjugated Nanomedicine
Chemotherapy is one of the standard methods for the clinical treatment of malignant tumors. Due to the heterogeneity of tumors and the complexity of their pathological mechanisms, a single chemotherapeutic drug is usually unable to eradicate cancer cells. It may also encounter some problems, such as toxic side effects induced by high doses of drugs and obtaining multidrug resistance (MDR) after repeated treatment. These problems then increase the likelihood of cancer metastasis or recurrence. The emergence of the combination of multiple antineoplastic drugs makes up for the deficiency of single drug application. Accordingly, the overall treatment benefit of the multidrug combination is usually higher than that of single drug administration by virtue of different therapeutic mechanisms. More importantly, the drug dose used during synergistic therapy usually decreases and the unfavorable side effects could be weakened under the premise of the same or better therapeutic efficacy. Thereinto, conjugated nanomedicine, as an important type of nanomedicine, can not only possess the targeted delivery of chemotherapeutics with great precision but also achieve controlled drug release to avoid adverse effects. Meanwhile, conjugated nanomedicine provides the platform for combining several different therapeutic approaches (chemotherapy, photothermal therapy, photodynamic therapy, thermodynamic therapy, immunotherapy, etc.) with the purpose of achieving synergistic effects during cancer treatment.
  • 967
  • 09 Aug 2022
Topic Review
Regulations of RNA Metabolism by RNA-Binding Proteins
RNA-binding proteins (RBPs) are proteins that physically and functionally bind to RNA to regulate the RNA metabolism such as alternative splicing, polyadenylation, transport, maintenance of stability, localization, and translation. There is accumulating evidence that dysregulated RBPs play an essential role in the pathogenesis of malignant tumors including a variety of types of sarcomas. On the other hand, prognosis of patients with sarcoma, especially with sarcoma in advanced stages, is very poor, and almost no effective standard treatment has been established for most of types of sarcomas, highlighting the urgent need for identifying novel therapeutic targets based on the deep understanding of pathogenesis.
  • 741
  • 09 Aug 2022
Topic Review
Targeting Mitochondria in Kidney Diseases
Kidney function highly depends on mitochondria, organelles that regulate different metabolic pathways. Mitochondria-altered function and structure are present during acute kidney injury (AKI) and chronic kidney disease (CKD).
  • 1.6K
  • 08 Aug 2022
Topic Review
Assessment of Negative Gingival Recession
Accurate measurement of negative gingival recession (GR) is essential to accurately determine the clinical attachment loss, which leads to an accurate diagnosis and optimal therapy of periodontal disease.
  • 1.8K
  • 10 Aug 2022
Topic Review
Skin-Lightening Active Ingredients in Japan
Japanese pharmaceutical cosmetics, often referred to as quasi-drugs, contain skin-lightening active ingredients formulated to prevent sun-induced pigment spots and freckles. Their mechanisms of action include suppressing melanin production in melanocytes and promoting epidermal growth to eliminate melanin more rapidly. For example, arbutin and rucinol are representative skin-lightening active ingredients that inhibit melanin production, and disodium adenosine monophosphate and dexpanthenol are skin-lightening active ingredients that inhibit melanin accumulation in the epidermis. In contrast, oral administration of vitamin C and tranexamic acid in pharmaceutical products can lighten freckles and melasma, and these products are more effective than quasi-drugs. On the basis of their clinical effectiveness, skin-lightening active ingredients can be divided into four categories according to their effectiveness and adverse effects.
  • 7.3K
  • 08 Aug 2022
Topic Review
CXCL12/CXCR4 Biological Axis and Its Physiological Functions
The CXCL12/CXCR4 biological axis is a coupled molecular pair, which is formed by the interaction of CXCL12 and its corresponding receptor CXCR4, and is closely related to intercellular messaging and cell migration.
  • 3.4K
  • 05 Aug 2022
Topic Review
MSC-Secretome for Autoimmune and Immune-mediated Inflammatory Diseases
Immune-mediated inflammatory diseases (IMIDs) encompass several entities such as “classic” autoimmune disorders or immune-mediated diseases with autoinflammatory characteristics. Adult stem cells including mesenchymal stem cells (MSCs) are by far the most commonly used type in clinical practice. However, due to the possible side effects of MSC-based treatments, there is an increase in interest in the MSC-secretome (containing large extracellular vesicles, microvesicles, and exosomes) as an alternative therapeutic option in IMIDs. A wide spectrum of MSC-secretome-related biological activities has been proven including anti-inflammatory, anti-apoptotic, and immunomodulatory properties. In comparison with MSCs, the secretome is less immunogenic but exerts similar biological actions, so it can be considered as an ideal cell-free therapeutic alternative. 
  • 1.3K
  • 08 Aug 2022
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