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
Hyperthermia to Treat Cancer in Low-Middle-Income Group Countries
Loco-regional hyperthermia at 40–44 °C is a multifaceted therapeutic modality with the distinct triple advantage of being a potent radiosensitizer, a chemosensitizer and an immunomodulator. Risk difference estimates from pairwise meta-analysis have shown that the local tumour control could be improved by 22.3% (p < 0.001), 22.1% (p < 0.001) and 25.5% (p < 0.001) in recurrent breast cancers, locally advanced cervix cancer (LACC) and locally advanced head and neck cancers, respectively by adding hyperthermia to radiotherapy over radiotherapy alone. 
  • 331
  • 06 May 2023
Topic Review
DNA Origami Nanostructures
Rapid breakthroughs in nucleic acid nanotechnology have always driven the creation of nano-assemblies with programmable design, potent functionality, good biocompatibility, and remarkable biosafety during the last few decades. Researchers are constantly looking for more powerful techniques that provide enhanced accuracy with greater resolution. The self-assembly of rationally designed nanostructures is now possible because of bottom-up structural nucleic acid (DNA and RNA) nanotechnology, notably DNA origami. Because DNA origami nanostructures can be organized precisely with nanoscale accuracy, they serve as a solid foundation for the exact arrangement of other functional materials for use in a number of applications in structural biology, biophysics, renewable energy, photonics, electronics, medicine, etc. DNA origami facilitates the creation of next-generation drug vectors to help in the solving of the rising demand on disease detection and therapy, as well as other biomedicine-related strategies in the real world. These DNA nanostructures, generated using Watson–Crick base pairing, exhibit a wide variety of properties, including great adaptability, precise programmability, and exceptionally low cytotoxicity in vitro and in vivo. 
  • 543
  • 08 May 2023
Topic Review
Enzyme-Associated Pathogenesis Mechanisms of Alzheimer’s Disease
Alzheimer’s disease (AD) is the most common form of dementia. It increases the risk of other serious diseases and causes a huge impact on individuals, families, and socioeconomics. AD is a complex multifactorial disease, and current pharmacological therapies are largely based on the inhibition of enzymes involved in the pathogenesis of AD.
  • 384
  • 04 May 2023
Topic Review
Intervertebral Disc Degeneration Therapy
Intervertebral disc degeneration (IDD) and associated conditions are an important problem in modern medicine. The onset of IDD may be in childhood and adolescence in patients with a genetic predisposition. With age, IDD progresses, leading to spondylosis, spondylarthrosis, herniated disc, spinal canal stenosis. One of the leading mechanisms in the development of IDD and chronic back pain is an imbalance between pro-inflammatory and anti-inflammatory cytokines. 
  • 361
  • 04 May 2023
Topic Review
Immunopotentiating Activity of Fucoidans
Fucoidans, discovered in 1913, are fucose-rich sulfated polysaccharides extracted mainly from brown seaweed. These versatile and nontoxic marine-origin heteropolysaccharides have a wide range of favorable biological activities, including antitumor, immunomodulatory, antiviral, antithrombotic, anticoagulant, antithrombotic, antioxidant, and lipid-lowering activities. In the early 1980s, fucoidans were first recognized for their role in supporting the immune response and later, in the 1990s, their effects on immune potentiation began to emerge. The understanding of the immunomodulatory effects of fucoidan has expanded significantly. The ability of fucoidan(s) to activate CTL-mediated cytotoxicity against cancer cells, strong antitumor property, and robust safety profile make fucoidans desirable for effective cancer immunotherapy.
  • 352
  • 06 May 2023
Topic Review
Biosynthetic Pathway of Heme b
Hemes belong to a small subgroup of the tetrapyrrole family, which is characterized by the combination of a ferrous ion and a porphyrin macrocycle. The ‘true’ hemes possess a fully oxidized porphyrin macrocycle, including heme a, heme b, heme c, and heme o. Hemes are an important class of prosthetic molecules that play roles in a number of biological processes. The most widespread and ubiquitous is heme b, which plays an important role in transporting oxygen as part of hemoglobin. In addition, heme b is a cofactor for many enzymes, such as myoglobin, cytochrome P450, and peroxidases, and plays significant roles in catalysis, transcription, signaling, and electron transfer. 
  • 524
  • 27 Apr 2023
Topic Review
DNA-Based Nanomaterials as Drug Delivery Platforms in Tumors
DNA nanotechnology has significantly advanced and might be used in biomedical applications, drug delivery, and cancer treatment. DNA nanomaterials are widely used in biomedical research involving biosensing, bioimaging, and drug delivery since they are remarkably addressable and biocompatible. Gradually, modified nucleic acids have begun to be employed to construct multifunctional DNA nanostructures with a variety of architectural designs. Aptamers are single-stranded nucleic acids (both DNAs and RNAs) capable of self-pairing to acquire secondary structure and of specifically binding with the target. Diagnosis and tumor therapy are prospective fields in which aptamers can be applied. Many DNA nanomaterials with three-dimensional structures have been studied as drug delivery systems for different anticancer medications or gene therapy agents. Different chemical alterations can be employed to construct a wide range of modified DNA nanostructures. Chemically altered DNA-based nanomaterials are useful for drug delivery because of their improved stability and inclusion of functional groups.
  • 637
  • 27 Apr 2023
Topic Review
Synthesis and Characterization of Proteinoid and Nanocapsules
Proteinoids are random polymers composed of amino acids synthesized by stepwise thermal polymerization. They were discovered and studied in the 1950s by Fox and coworkers, who suggested that they formed spontaneously by high heat at the beginning of life on Earth. Nanocapsules (NCs) form spontaneously by heating proteinoids to about 70 °C in an aqueous solution to completely dissolve the polymers, followed by slow cooling to room temperature.
  • 431
  • 27 Apr 2023
Topic Review
Nano-Gels in Skin Cancer
Nano-gels, a dual combination of hydrogels and nanoparticles, have demonstrated significant promise as a targeted drug delivery system in the treatment of cancer, attributing to excellent drug loading capacity. Skin disorders, the 4th foremost source of non-fatal diseases, are frequently the outward manifestation of more serious systemic illnesses, such as HIV, and neglected tropical diseases, such as elephantiasis and other ailments causing lymphedema.
  • 467
  • 27 Apr 2023
Topic Review
Tregs in Psoriasis
Psoriasis is a chronic inflammatory skin disease, which affects 2–4% of the population worldwide. Psoriasis has a strong genetic component, but environmental factors are also important. T-cell derived factors such as Psoriasis is characteristic, with thickening and scaling of the epidermisdue to hyper-proliferation of keratinocytes (acanthosis). CD4 and CD8 T-cell infiltrate characterizes the skin in psoriasis, a T-cell-driven disease, but other cell types are also present in the lesions, including neutrophils, macrophages, NK cells, dendritic cells. It has been long known that the pathogenesis of psoriasis is driven by T-cell derived factors, produced by subsets including T-helper (Th) 1 cells, Th17, Th22 and regulatory T cells (Tregs). 
  • 263
  • 27 Apr 2023
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