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
Chronicles of Nanoerythrosomes
Nanoerythrosomes (NERs) are the carrier erythrocytes (C-ERs) which are recognized as modern day, novel, and smart drug delivery systems associated with increased bioavailability, improved pharmacokinetics, and low toxicity.
  • 661
  • 30 Apr 2021
Topic Review
Volatile Anesthetic-Induced Organ Protection
Ischemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively impacts graft and patient outcome. Reperfusion takes place in the recipient and most of the injury following ischemia and reperfusion occurs during this reperfusion phase; therefore, the intra-operative period seems an attractive window of opportunity to modulate IRI and improve short- and potentially long-term graft outcome. Commonly used volatile anesthetics such as sevoflurane and isoflurane have been shown to interfere with many of the pathophysiological processes involved in the injurious cascade of IRI. 
  • 514
  • 29 Apr 2021
Topic Review
Neuroprotection of Quercetin
Quercetin possess multiple pharmacological applications including anti-inflammatory, antitumoral, antiapoptotic and anti-thrombotic activities, widely demonstrated in both in vitro and in vivo studies.
  • 510
  • 22 Apr 2021
Topic Review
Supercritical Carbon-di-Oxide Technology for Polymeric-Particles
Supercritical carbon dioxide (SC-CO2)  based techniques can be exploited for the formulation of polymeric nanocarriers, limiting the use of toxic organic solvent. The currently approved FDA pharmaceutical polymers like PLA and PLGA particles can be obtained in the micro-and nanometer range by techniques that involve SC-CO2 as solvent (RESS, RESOLV), anti-solvent (SAS, SEDS, SAILA) or extractant (SFEE), depending on the SC-CO2 compatibility with the system materials and the final product.
  • 561
  • 27 Apr 2021
Topic Review
Glycosphingolipid Antigens and Human Diseases
Glycosphingolipids (GSLs) are composed of a mono-, di-, or oligosaccharide and a ceramide and function as constituents of cell membranes. Various molecular species of GSLs have been identified in mammalian cells due to differences in the structures of oligosaccharides. The oligosaccharide structure can vary depending on cell lineage, differentiation stage, and pathology; this property can be used as a cell identification marker. 
  • 636
  • 18 Apr 2021
Topic Review
Lipopolysaccharide, Inflammation and Mitochondria-Targeted Antioxidants
Lipopolysaccharide (LPS), the major component of the outer membrane of Gram-negative bacteria, is the most abundant proinflammatory agent. Considerable evidence indicates that LPS challenge inescapably causes oxidative stress and mitochondrial dysfunction, leading to cell and tissue damage. Increased mitochondrial reactive oxygen species (mtROS) generation triggered by LPS is known to play a key role in the progression of the inflammatory response. mtROS at excessive levels impair electron transport chain functioning, reduce the mitochondrial membrane potential, and initiate lipid peroxidation and oxidative damage of mitochondrial proteins and mtDNA. Over the past 20 years, a large number of mitochondria-targeted antioxidants (mito-AOX) of different structures that can accumulate inside mitochondria and scavenge free radicals have been synthesized. Their protective role based on the prevention of oxidative stress and the restoration of mitochondrial function has been demonstrated in a variety of common diseases and pathological states.
  • 595
  • 16 Apr 2021
Topic Review
Guava Leaves
Psidium guajava (L.) belongs to the Myrtaceae family and it is an important fruit in tropical areas like India, Indonesia, Pakistan, Bangladesh, and South America. The leaves of the guava plant have been studied for their health benefits which are attributed to their plethora of phytochemicals, such as quercetin, avicularin, apigenin, guaijaverin, kaempferol, hyperin, myricetin, gallic acid, catechin, epicatechin, chlorogenic acid, epigallocatechin gallate, and caffeic acid. Extracts from guava leaves (GLs) have been studied for their biological activities, including anticancer, antidiabetic, antioxidant, antidiarrheal, antimicrobial, lipid-lowering, and hepatoprotection activities.
  • 9.9K
  • 14 Apr 2021
Topic Review
Delivery Systems for Nucleic Acids/Proteins
Gene therapy has been used as a potential approach to address the diagnosis and treatment of genetic diseases and inherited disorders. In this line, non-viral systems have been exploited as promising alternatives for delivering therapeutic transgenes and proteins. In this entry, we explored how biological barriers are effectively overcome by non-viral systems, usually nanoparticles, to reach an efficient delivery of cargoes.
  • 731
  • 31 Mar 2021
Topic Review
Biopolymeric Materials as Nonviral Vectors
Bacterial transformation and gene transfection can be understood as being the results of introducing specific genetic material into cells, resulting in gene expression, and adding a new genetic trait to the host cell. Many studies have been carried out to investigate different types of lipids and cationic polymers as promising nonviral vectors for DNA transfer. The present study focused on the use of biopolymeric materials as nonviral vectors. The methodology was carried out based on searches of scientific articles and applications for patents published or deposited from 2006 to 2020 in different databases for patents (EPO, USPTO, and INPI) and articles (Scopus, Web of Science, and Scielo). The results showed that there are some deposits of patents regarding the use of chitosan as a gene carrier. The 16 analyzed articles allowed us to infer that the use of biopolymers as nonviral vectors is limited due to the low diversity of biopolymers used for these purposes. It was also observed that the use of different materials as nonviral vectors is based on chemical structure modifications of the material, mainly by the addition of cationic groups. Thus, the use of biopolymers as nonviral vectors is still limited to only a few polysaccharide types, emphasizing the need for further studies involving the use of different biopolymers in processes of gene transfer.
  • 474
  • 05 Apr 2021
Topic Review
Flavonols
Flavonols are ones of the most common phytochemicals found in diets rich in fruit and vegetables. Research suggests that molecular functions of flavonoids may bring a number of health benefits to people, including the following: decrease inflammation, change disease activity, and alleviate resistance to antibiotics as well as chemotherapeutics. 
  • 900
  • 23 Mar 2021
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