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
Strategies for Improving Transdermal Administration
A transdermal delivery system is a painless method of drug administration through intact skin. Transdermal patches favor the controlled release of active ingredients through the skin into systemic circulation.Substances with analgesic effects can be administered on the skin in the form of topical patches made to produce local effects or transdermal patches that ensure the controlled and prolonged release of the active substance.
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  • 18 Apr 2023
Topic Review
Aptamer-Based Immune Strategies for TNBC Treatment
Aptamer-based immunotherapy has great potential to overcome significant challenges in T cell immunotherapy for solid tumors mainly represented by strong immunosuppressive signals, which induce low T cell activation and decreased synthesis and release of cytotoxic proteins.
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Topic Review
Biological Melatonin versus Synthetic Melatonin
Melatonin dietary supplements are widely consumed worldwide, with developed countries as the largest consumers, with an estimated annual growth rate of approximately 10% until 2027, mainly in developing countries. The wide use of melatonin against sleep disorders and particular problems, such as jet lag, has been added to other applications, such as anti-aging, anti-stress, immune system activation, anticancer, and others, which have triggered its use, normally without a prescription. The chemical industry currently covers 100% of the needs of the melatonin market.
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  • 18 Apr 2023
Topic Review
Selenium Nanoparticles
Dietary selenium (Se) intake within the physiological range is critical to maintain various biological functions, including antioxidant defence, redox homeostasis, growth, reproduction, immunity, and thyroid hormone production. Chemical forms of dietary Se are diverse, including organic Se (selenomethionine, selenocysteine, and selenium-methyl-selenocysteine) and inorganic Se (selenate and selenite). Previous studies have largely investigated and compared the health impacts of dietary Se on agricultural stock and humans, where dietary Se has shown various benefits, including enhanced growth performance, immune functions, and nutritional quality of meats, with reduced oxidative stress and inflammation, and finally enhanced thyroid health and fertility in humans. The emergence of nanoparticles presents a novel and innovative technology. Notably, Se in the form of nanoparticles (SeNPs) has lower toxicity, higher bioavailability, lower excretion in animals, and is linked to more powerful and superior biological activities (at a comparable Se dose) than traditional chemical forms of dietary Se. As a result, the development of tailored SeNPs for their use in intensive agriculture and as an innovative candidate for therapeutic drugs for human pathologies is being actively explored. 
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Topic Review
Yeast-Based Virus-like Particles
Virus-like particles (VLPs) are empty, nanoscale structures morphologically resembling viruses. Internal cavity, noninfectious, and particulate nature with a high density of repeating epitopes, make them an ideal platform for vaccine development and drug delivery. 
  • 1.7K
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Topic Review
Probiotics and Prebiotics Concepts
Probiotics are microorganisms which, if taken in sufficient quantities, contribute positively to the health of the host and are the focus of both scientific studies and commercial companies. 
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  • 06 Apr 2023
Topic Review
Applications of Solid Lipid Nanoparticles in Cancer
Cancer is recognized as one of the world’s most deadly diseases in its different forms. In the field of nanotechnology, solid lipid nanoparticles (SLNs) play a vital role with a wide range of diverse applications, namely drug delivery, clinical medicine, and cancer therapeutics. SLNs establish a significant role owing to their ability to encapsulate hydrophilic and hydrophobic compounds, biocompatibility, ease of surface modification, scale-up feasibility, and possibilities of both active and passive targeting to various organs. In cancer therapy, SLNs have emerged as imminent nanocarriers for overcoming physiological barriers and multidrug resistance pathways.
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Topic Review
Lipid-Based Nanocarrier Systems
Nanotechnology-based tools have played a major role in this. The implementation of this multifaceted nanotechnology concept encourages the advancement of innovative strategies and materials for improving patient compliance.
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  • 03 Apr 2023
Topic Review
Types of Lipid-Based Nanocarriers for Vaccine Delivery
Lipid-based vaccine delivery systems such as the conventional liposomes, virosomes, bilosomes, vesosomes, pH-fusogenic liposomes, transferosomes, immuno-liposomes, ethosomes, and lipid nanoparticles have gained a remarkable interest in vaccine delivery due to their ability to render antigens in vesicular structures, that in turn prevents its enzymatic degradation in vivo. The particulate form of lipid-based nanocarriers confers immunostimulatory potential, making them ideal antigen carriers.
  • 1.5K
  • 31 Mar 2023
Topic Review
Bio-Based Materials for Chronic Diabetic Wounds
Globally, millions of people suffer from poor wound healing, which is associated with higher mortality rates and higher healthcare costs. There are several factors that can complicate the healing process of wounds, including inadequate conditions for cell migration, proliferation, and angiogenesis, microbial infections, and prolonged inflammatory responses.
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  • 30 Mar 2023
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