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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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.
  • 38
  • 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.
  • 39
  • 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.
  • 79
  • 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. 
  • 41
  • 08 Aug 2022
Topic Review
Structure-Based Virtual Screening
Molecular docking plays a significant role in early-stage drug discovery, from structure-based virtual screening (VS) to hit-to-lead optimization. VS is a computational approach used to identify chemical structures that are predicted to have particular properties. In drug discovery, it involves computationally searching large libraries of chemical structures to identify those structures that are most likely to bind to a target protein.
  • 38
  • 04 Aug 2022
Topic Review
Bovine Respiratory Disease
Bovine Respiratory Disease is considered one of the most common diseases within the Australian beef industry. During the transitioning period of young cattle going into the feedlot system they experience multiple stressors such as environmental changes, dehydration, and fatigue. These stressors negatively impact on the animals’ overall health by markedly increasing physiological stress and decreasing immune response making them more susceptible to diseases, such as bovine respiratory disease complex (BRD).
  • 63
  • 01 Aug 2022
Topic Review
Phytochemical and Potential Properties of Seaweeds
Seaweeds have been employed as source of highly bioactive secondary metabolites that could act as key medicinal components. Seaweeds have many uses: they are consumed as fodder, and have been used in medicines, cosmetics, energy, fertilizers, and industrial agar and alginate biosynthesis. The beneficial effects of seaweed are mostly due to the presence of minerals, vitamins, phenols, polysaccharides, and sterols, as well as several other bioactive compounds. These compounds seem to have antioxidant, anti-inflammatory, anti-cancer, antimicrobial, and anti-diabetic activities.
  • 48
  • 01 Aug 2022
Topic Review
Evaluation of Biological Activity of Natural Compounds
Natural compounds have diverse structures and are present in different forms of life. Metabolites such as tannins, anthocyanins, and alkaloids, among others, serve as a defense mechanism in live organisms and are undoubtedly compounds of interest for the food, cosmetic, and pharmaceutical industries.
  • 33
  • 01 Aug 2022
Topic Review
Precision Anti-Cancer Medicines by Oligonucleotide in Clinical Reasearch
Oligonucleotide therapeutics enable a direct targeting of the gene by acting at the level of the RNA or at the level of the DNA, based on the Watson-Crick complementary rule of binding.
  • 37
  • 29 Jul 2022
Topic Review
Poly(N-isopropylacrylamide)-Based Hydrogels
Poly(N-isopropylacrylamide) (PNIPAM) is a widely utilized negative thermosensitive polymer (as it has increased solubility with lowering of temperature, causing volume phase transition by forming hydrogen bonds) that has currently sparkled a lot of scientific inquisitiveness. Smart hydrogels based on PNIPAM demonstrate distinct thermoresponsive features close to a lower critical solution temperature (LCST) that enhance their capability in various biomedical applications such as drug delivery, tissue engineering, and wound dressings.
  • 37
  • 29 Jul 2022
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