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
Peptide-Assisted Nucleic Acid Delivery Systems
Advances in peptide development have made peptide-assisted gene delivery more efficient in vitro and, in some instances, in small animal models. For example, cell and tissue selectivity could be greatly enhanced in the newest generation of CPPs. Other advances which allow for improved performance with regard to targeting and delivery of nucleic acids include adapting peptide sequences to facilitate escape or release from intracellular vesicles or respond to environmental stimuli for a controlled release of cargo, and the development of composite, multivalent peptide-based, or peptide-coupled structures.
  • 498
  • 08 Sep 2021
Topic Review
Enzyme Therapy
In recent years, enzymes have risen as promising therapeutic tools for different pathologies, from metabolic deficiencies, such as fibrosis conditions, ocular pathologies or joint problems, to cancer or cardiovascular diseases. Treatments based on the catalytic activity of enzymes are able to convert a wide range of target molecules to restore the correct physiological metabolism. These treatments present several advantages compared to established therapeutic approaches thanks to their affinity and specificity properties. However, enzymes present some challenges, such as short in vivo half-life, lack of targeted action and, in particular, patient immune system reaction against the enzyme. For this reason, it is important to monitor serum immune response during treatment. This can be achieved by conventional techniques (ELISA) but also by new promising tools such as microarrays. These assays have gained popularity due to their high-throughput analysis capacity, their simplicity, and their potential to monitor the immune response of patients during enzyme therapies. In this growing field, research is still ongoing to solve current health problems such as COVID-19. Currently, promising therapeutic alternatives using the angiotensin-converting enzyme 2 (ACE2) are being studied to treat COVID-19.
  • 1.6K
  • 06 Sep 2021
Topic Review
CYP3A4
CYP3A4 is a low specificity isoenzyme of the CYPs family, which contributes to the metabolism of approximately 50% of all marketed drugs. Induction or inhibition of CYP3A4 activity results in the varied oral bioavailability and unwanted drug-drug, drug-food, and drug-herb interactions.
  • 3.0K
  • 01 Sep 2021
Topic Review
Punicalagin in Cancer Prevention
Punicalagin, present in pomegranate, myrobalan, yellow wood, tropical almond, and pink rock-rose, belongs to ellagitannins - a subgroup of hydrolyzable tannins. In vitro studies, based on cell line experiments, have demonstrated punicalagin anti-cancer actions on human cervical, ovarian, breast, lung, thyroid, colorectal, central nervous system, bone, as well as other cancer types. Punicalagin seems to work through a redirection of signal-transduction pathways from survival and proliferation into cell-cycle arrest, apoptosis, senescence or autophagy (thus compromising neoplastic progression). However, since it readily undergoes hydrolysis releasing e.g. ellagic acid, these might be its products which are responsible for the observed effects. Moreover, when practical application of punicalagin in chemoprevention is addressed, its biotransformation in the human organism should be considered (including both host and microbiome enzymatic impact). Therefore, however promising punicalagin antineoplastic properties seem to be, in vivo-based research should be conducted before translating the results obtained from in vitro studies into practice.
  • 812
  • 26 Aug 2021
Topic Review
Antibacterial Secondary Metabolites from Basidiomycetes
Fungi are a rich source of secondary metabolites with several pharmacological activities such as antifungal, antioxidant, antibacterial and anticancer to name a few. Due to the large number of diverse structured chemical compounds they produce, fungi from the phyla Ascomycota, Basidiomycota and Muccoromycota have been intensively studied for isolation of bioactive compounds. Basidiomycetes-derived secondary metabolites are known as a promising source of antibacterial compounds with activity against Gram-positive bacteria. The continued emergence of antimicrobial resistance (AMR) poses a major challenge to patient health as it leads to higher morbidity and mortality, higher hospital-stay duration and substantial economic burden in global healthcare sector. One of the key culprits for AMR crisis is Staphylococcus aureus causing community-acquired infections as the pathogen develops resistance towards multiple antibiotics. The recent emergence of community strains of S. aureus harbouring methicillin-resistant (MRSA), vancomycin-intermediate (VISA) and vancomycin-resistant (VRSA) genes associated with increased virulence is challenging. Despite the few significant developments in antibiotic research, successful MRSA therapeutic options are still needed to reduce the use of scanty and expensive second-line treatments. This paper provides an overview of findings from various studies on antibacterial secondary metabolites from basidiomycetes, with a special focus on antistaphylococcal activity.
  • 872
  • 20 Aug 2021
Topic Review
Cannabidiol as an OX1R Antagonist
The potential, multifaceted therapeutic profile of cannabidiol (CBD), a major constituent derived from the Cannabis sativa plant, covers a wide range of neurological and psychiatric disorders, ranging from anxiety to pediatric epilepsy and drug addiction. However, the molecular targets responsible for these effects have been only partially identified. In this view, the involvement of the orexin system, the key regulator in arousal and the sleep/wake cycle, and in motivation and reward processes, including drug addiction, prompted us to explore, using computational and experimental approaches, the possibility that CBD could act as a ligand of orexin receptors, orexin 1 receptor of type 1 (OX1R) and type 2 (OX2R). Ligand-binding assays showed that CBD is a selective ligand of OX1R in the low micromolar range (Ki 1.58 ± 0.2 μM) while in vitro functional assays, carried out by intracellular calcium imaging and mobilization assays, showed that CBD acts as an antagonist at this receptor. Finally, the putative binding mode of CBD has been inferred by molecular docking and molecular dynamics simulations and its selectivity toward the OX1R subtype rationalized at the molecular level. This study provides the first evidence that CBD acts as an OX1R antagonist, supporting its potential use in addictive disorders and/or body weight regulation. 
  • 607
  • 18 Aug 2021
Topic Review
Lipophilic Polyamines
Gene therapy requires an effective and safe delivery vehicle for nucleic acids. Non-viral vehicles, including cationic liposomes, are intensively developed now. The structure of compounds composing them determines the delivery efficiency a lot. This review focuses on polycationic amphiphiles as prospective compounds for liposomal formulations and includes a discussion of the mutual influence of structural components. 
  • 510
  • 11 Aug 2021
Topic Review
Grape Infusions
Grape-infusion preparation is no more than a sustainable or green way of extracting polyphenols and other nutraceutical compounds from grapes and grape leaves.  Grapes and grape/wine by-products are a rich source of health-promoting compounds, presenting great potential for the development of new beverages. 
  • 1.3K
  • 11 Aug 2021
Topic Review
Omega-3's Biological Actions
Schizophrenia is a severe psychiatric disorder affecting more than 20 million individuals worldwide. According to the well-established clinical staging model, schizophrenia is a progressive illness that typically emerges during late adolescence and transitions through several evolving stages: early vulnerability, at-risk mental state (also called ultra-high risk, abbreviated UHR), first episode psychosis (FEP), and chronic schizophrenia. The transition from one stage to the other is not inevitable, and it has been observed that only one-third of UHR individuals convert to psychosis after a 3-year follow-up.
  • 421
  • 06 Aug 2021
Topic Review
Actinobacteria and Environmental Adaptations
Actinobacteria are among the secondary metabolites producers and hold high pharmacological and commercial interest. It has great capability to produce secondary metabolites such as immunomodulators, antibiotics, anti-cancer drugs, growth factors, anthelminthic enzymes and herbicides.describes the historical isolation of bioactive compounds from Actinobacteria from the first isolation by Selman Waksman.
  • 1.0K
  • 05 Aug 2021
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