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
Potentiality of Nanoenzymes for Cancer Treatment
Nanozyme synthesis is an innovative technology since it connects nanoparticles with biological activities and framework. Various assays have been implemented for the enzymes of proteins that also implement nanozymes, which could also have the potential for performing the catalysis of similar substrates. Due to such different functions of nanozymes, they are used for the treatment of the environment, biosensing, agents that act against microbes, cytoprotection of different cell biomolecules with management, diagnosis of diseases, etc..
  • 533
  • 22 Oct 2021
Topic Review
Biomedical Applications of Plant-Mediated Zinc Oxide Nanoparticles
Zinc oxide nanoparticles have become one of the most popular metal oxide nanoparticles and recently emerged as a promising potential candidate in the fields of optical, electrical, food packaging, and biomedical applications due to their biocompatibility, low toxicity, and low cost. They have a role in cell apoptosis, as they trigger excessive reactive oxygen species (ROS) formation and release zinc ions (Zn2+) that induce cell death. The zinc oxide nanoparticles synthesized using the plant extracts appear to be simple, safer, sustainable, and more environmentally friendly compared to the physical and chemical routes. These biosynthesized nanoparticles possess strong biological activities and are in use for various biological applications in several industries. Initially, the present review discusses the synthesis and recent advances of zinc oxide nanoparticles from plant sources (such as leaves, stems, bark, roots, rhizomes, fruits, flowers, and seeds) and their biomedical applications (such as antimicrobial, antioxidant, antidiabetic, anticancer, anti-inflammatory, photocatalytic, wound healing, and drug delivery), followed by their mechanisms of action involved in detail. 
  • 1.1K
  • 21 Oct 2021
Topic Review
3D Printing in Pharmaceutical Application
Advances in three-dimensional (3D) printing techniques and the development of tailored biomaterials have facilitated the precise fabrication of biological components and complex 3D geometrics over the past few decades. Moreover, the notable growth of 3D printing has facilitated pharmaceutical applications, enabling the development of customized drug screening and drug delivery systems for individual patients, breaking away from conventional approaches that primarily rely on transgenic animal experiments and mass production.
  • 667
  • 25 Jan 2022
Topic Review
Protein Analysis of Gene Mutations in Conjunctival Melanoma
Genetics is the basis of many neoplasms, including conjunctival melanoma (CM). Here, we analyzed five proteins associated with CM, namely BRAF, NRAS, c-KIT, NF1, and PTEN and investigated structures of BRAF, NRAS, c-KIT, and PTEN generated with AlphaFold, and NF1 structure from the Protein Databank (PDB). The Predictor of Natural Disordered Protein Regions (PONDR®), the web server for the prediction of intrinsically unstructured regions of proteins (IUPred), and the mean disorder profile (MDP) were utilized to analyze each protein for intrinsically disordered protein regions (IDPRs). AlphaFold and PDB structures show the presence of IDPRs in all five proteins. The bioinformatics analysis confirmed high levels of disorder in these proteins, with most disordered being BRAF (45.95%), followed by PTEN (31.76%), NF1 (22.19%), c-KIT (21.82%), and NRAS (14.81%). Our STRING analysis found that each of these five proteins had more predicted interactions then expected (p-value < 1.0 × 10−16). Our analysis demonstrates that the mutations linked to CM likely affected IDPRs and possibly altered their highly complex PPIs. Quantifying IDPRs in BRAF, NRAS, c-KIT, NF1, and PTEN and understanding these protein regions are important processes as IDPRs can be possible drug targets for novel targeted therapies for treating CM.
  • 532
  • 21 Oct 2021
Topic Review
Mevalonate Kinase Deficiency and Squalene Synthase Inhibitor (TAK-475)
Mevalonate Kinase Deficiency (MKD) is a rare inborn disease belonging to the family of periodic fever syndromes. The MKD phenotype is characterized by systemic inflammation involving multiple organs, including the nervous system. Current anti-inflammatory approaches to MKD are only partially effective and do not act specifically on neural inflammation. According to the new emerging pharmacology trends, the repositioning of drugs from the indication for which they were originally intended to another one can make mechanistic-based medications easily available to treat rare diseases. According to this perspective, the squalene synthase inhibitor Lapaquistat (TAK-475), originally developed as a cholesterol-lowering drug, might find a new indication in MKD, by modulating the mevalonate cholesterol pathway, increasing the availability of anti-inflammatory isoprenoid intermediates.
  • 576
  • 19 Oct 2021
Topic Review
Bulbous Plants Drimia
Drimia (synonym Urginea) plants are bulbous plants belonging to the family Asparagaceae (formerly the family Hyacinthaceae) and are distinctive, powerful medicinal plants. Just some species are indigenous to South Africa and have been traditionally utilized for centuries to cure various diseases and/or ailments. They have been recognized among the most famous and used medicinal plants in South Africa. Traditionally, the plants are used for various illnesses such as dropsy, respiratory disease, bone and joint complications, skin disorders, epilepsy and cancer. A number of studies have reported biological properties such as antiviral, antibacterial, antioxidant and anti-inflammatory, immunomodulatory, and anticancer activities. Their bulbs are a popular treatment for colds, measles, pneumonia, coughs, fever and headaches. 
  • 699
  • 18 Oct 2021
Topic Review
Melatonin for the Inhibition of Hypoxia-Induced Tumor Progression
Hypoxia has an important role in tumor progression via the upregulation of growth factors and cellular adaptation genes. These changes promote cell survival, proliferation, invasion, metastasis, angiogenesis, and energy metabolism in favor of cancer development. Hypoxia also plays a central role in determining the resistance of tumors to chemotherapy. Hypoxia of the tumor microenvironment provides an opportunity to develop new therapeutic strategies that may selectively induce apoptosis of the hypoxic cancer cells. Melatonin is well known for its role in the regulation of circadian rhythms and seasonal reproduction. Numerous studies have also documented the anti-cancer properties of melatonin including anti-proliferation, anti-angiogenesis, and apoptosis promotion. Here, we hypothesized that melatonin exerts the anti-cancer effects by inhibiting the hypoxia-induced pathways. Considering this action, co-administration of melatonin in combination with other therapeutic medications might increase the effectiveness of anti-cancer drugs. We explained the possible signaling pathways by which melatonin inhibits the hypoxia-induced cancer cell survival, invasion, migration, and metabolism as well as tumor angiogenesis (This context is extracted from our published review study).
  • 510
  • 13 Oct 2021
Topic Review
Gadolinium-Based Oxide and Oxysulfide Particles
Gadolinium-Based Oxide and Oxysulfide Particles in the biomedical field
  • 669
  • 14 Oct 2021
Topic Review
Low-Protein Diet for CKD
The epidemiology of chronic kidney disease (CKD) shows increasing trends in prevalence and mortality and has become the leading health problem worldwide. Reducing the amount of proteins ingested from rice is an easy way to control the total intake of proteins, saving energy sources, particularly in rice-eating countries. 
  • 706
  • 08 Oct 2021
Topic Review
Natural Products from Madagascar
Natural products with biological activity represent a primary source of commodities ranging from human nutrition to therapy. Also they may represent cosmetic principles and/or recreational tools. These natural means have been used by mankind for centuries, if not millennia. They are commonly used all over the world in socio-economical contexts, but are particularly attractive in disadvantaged areas or economically emerging situations all over the world because of their accessibility and low cost/use ratio.
  • 744
  • 08 Oct 2021
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