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
Vaccinium Species: Composition and Activity
The genus Vaccinium L. (Ericaceae) includes more than 450 species, which grow mainly in cooler areas of the northern hemisphere. Vaccinium species have been used in the traditional medicine of different cultures and the berries are widely consumed as food. Indeed, Vaccinium supplements-based herbal medicine and functional food, mainly from V. myrtillus and V. macrocarpon, are used in Europe and North America. Biological studies support traditional uses since for many of Vaccinium components important biological functions have been described, including antioxidant, antitumor, anti-inflammatory, antidiabetic, and endothelium protective activities. Vaccinium components, such as polyphenols, anthocyanins, and flavonoids, are widely recognized as modulators of cellular pathways involved in pathological conditions, thus indicating that Vaccinium may be an important source of bioactive molecules. 
  • 607
  • 14 Jul 2021
Topic Review
Melatonin on NLRP3 Inflammasome Activation
The NLRP3 inflammasome is a part of the innate immune system and responsible for the rapid identification and eradication of pathogenic microbes, metabolic stress products, reactive oxygen species, and other exogenous agents. NLRP3 inflammasome is overactivated in several neurodegenerative, cardiac, pulmonary, and metabolic diseases. Therefore, suppression of inflammasome activation is of utmost clinical importance. Melatonin is a ubiquitous hormone mainly produced in the pineal gland with circadian rhythm regulatory, antioxidant, and immunomodulatory functions. Melatonin is a natural product and safer than most chemicals to use for medicinal purposes. Many in vitro and in vivo studies have proved that melatonin alleviates NLRP3 inflammasome activity via various intracellular signaling pathways.
  • 509
  • 07 Jul 2021
Topic Review
Pharmacological Interventions in Epilepsy
Epilepsy is a non-communicable disease of the brain that affects people of all ages. It is characterized by episodes of spontaneous and abnormal electrical activity in the brain. It is often accompanied by depression, anxiety, and substantially increased morbidity and mortality. A large number of third-generation antiepileptic drugs are available, but they have multiple side effects causing a decline in the quality of life. The inheritance and etiology of epilepsy are complex with multiple underlying genetic and epigenetic mechanisms. Different neurotransmitters play intricate functions to maintain the normal physiology of various neurons. 
  • 586
  • 06 Jul 2021
Topic Review
Natural Products from Reniera Sponges
Reniera is one subgenus of Haliclona sponges and has a soft texture and brownish-maroon epidermis, and its body looks like a compressed tree with simple digitate branches and spicules of various sizes and harbors a special arrangement of the flagellated chambers in the incurrent and excurrent canal systems.
  • 375
  • 02 Jul 2021
Topic Review
Herbal Biomedicines for Dermatological Disorders
Herbal extracts and isolated plant compounds play an increasing role in the treatment of skin disorders and wounds. Several new herbal drugs, medicinal products and cosmetic products for the treatment of various skin conditions have been developed in recent years. 
  • 677
  • 01 Jul 2021
Topic Review
Jasmonate Compounds
There are four known stereoisomers of jasmonic acid: trans-(−)-(3R,7R), abbreviated as (−)-JA; trans-(+)-(3S,7S) abbreviated as (+)-JA; cis-(−)-(3S,7R) abbreviated as (−)-epi-JA; cis-(+)-(3R,7S) abbreviated as (+)-epi-JA [15]. The naturally occurring jasmonic acid in plants is (−)-JA and (+)-epi-JA. Due to the fact that the cis stereoisomers are thermodynamically less stable, they epimerize at the C-7 atom to the stable trans form, which at the same time shows a higher biological activity. The biological activity of jasmonic acid has been found to be dependent on the presence of a carboxyl group at the C-1 position, a keto or hydroxyl group at the C-6 position, and a pentenyl side chain at the C-7 position. Because of this structure, jasmonates inhibit, induce and/or stimulate changes that occur in plants at the morphological, physiological, cellular and molecular levels.
  • 755
  • 29 Jun 2021
Topic Review
Non-Ionic Surfactants
Surfactants are essential in the manufacture of polymeric nanoparticles by emulsion formation methods and to preserve the stability of carriers in liquid media. The deposition of non-ionic surfactants at the interface allows a considerable reduction of the globule of the emulsion with high biocompatibility and the possibility of oscillating the final sizes in a wide nanometric range.
  • 4.0K
  • 29 Jun 2021
Topic Review
Natural/Designed Toxins for Precise Therapy
Cancer cells frequently overexpress specific surface receptors providing tumor growth and survival which can be used for precise therapy. Targeting cancer cell receptors with protein toxins is an attractive approach widely used in contemporary experimental oncology and preclinical studies.   
  • 489
  • 28 Jun 2021
Topic Review
Talazoparib and Niraparib
Niraparib (MK-4827) inhibits PARP1 and PARP2. It was approved by the U.S. Food and Drug Administration (FDA) in March 2017 indicated for the therapy of adult patients with ovarian, fallopian tube and peritoneal neoplasms. Talazoparib (BMN 673) is a potent and selective inhibitor of PARP1 and PARP2 used at lower concentrations than previous generations of PARP inhibitors. The FDA approved Talazoparib in October 2018 for patients with germline BRCA-mutated, HER2-negative breast cancer. Poly (ADP-ribose) polymerases (PARP) play an essential role in different cellular processes, including several pathways of DNA repair. PARP inhibitors (PARPi) are able to impair DNA damage repair by non-homologous end joining (NHEJ). This effect depends on the cell´s ability to compensate for the inhibition of PARP-mediated pathways by other repair pathways. PARPi especially induce cell death in cancer cells with a lack of PARP-independent DNA repair pathways.
  • 505
  • 25 Jun 2021
Topic Review
Gram-Negative Bacterial Lysins
Antibiotics have had a profound impact on human society by enabling the eradication of otherwise deadly infections. Unfortunately, antibiotic use and overuse has led to the rapid spread of acquired antibiotic resistance, creating a major threat to public health. Novel therapeutic agents called bacteriophage endolysins (lysins) provide a solution to the worldwide epidemic of antibiotic resistance. Lysins are a class of enzymes produced by bacteriophages during the lytic cycle, which are capable of cleaving bonds in the bacterial cell wall, resulting in the death of the bacteria within seconds after contact. Through evolutionary selection of the phage progeny to be released and spread, these lysins target different critical components in the cell wall, making resistance to these molecules orders of magnitude less likely than conventional antibiotics. Such properties make lysins uniquely suitable for the treatment of multidrug resistant bacterial pathogens. Lysins, either naturally occurring or engineered, have the potential of being developed into fast-acting, narrow-spectrum, biofilm-disrupting antimicrobials that act synergistically with standard of care antibiotics.
  • 645
  • 23 Jun 2021
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