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
Inocybe Mushrooms Poisoning
Mushroom poisoning has always been a threat to human health. There are a large number of reports about ingestion of poisonous mushrooms every year around the world. It attracts the attention of researchers, especially in the aspects of toxin composition, toxic mechanism and toxin application in poisonous mushroom. Inocybe is a large genus of mushrooms and contains toxic substances including muscarine, psilocybin, psilocin, aeruginascin, lectins and baeocystin. In order to prevent and remedy mushroom poisoning, it is significant to clarify the toxic effects and mechanisms of these bioactive substances. 
  • 9.6K
  • 10 Mar 2021
Topic Review
Nutraceutical Curcumin
Curcumin is a principal bioactive phenolic compound of the spice turmeric, in regard to various human and animal herpesvirus infections and inflammation connected with these diseases. Curcumin was explored with potent antiherpetic actions against herpes simplex virus type 1 and type 2, human cytomegalovirus, Kaposi’s sarcoma-associated herpesvirus, Epstein–Barr virus, bovine herpesvirus 1, and pseudorabies virus. 
  • 1.3K
  • 07 Mar 2021
Topic Review
Endolysins
Endolysins are phage-encoded enzymes utilized by mature phage virions to hydrolyze the cell wall from within. There is significant evidence that proves the ability of endolysins to degrade the peptidoglycan externally without the assistance of phage. Thus, their incorporation in therapeutic strategies has opened new options for therapeutic application against bacterial infections in the human and veterinary sectors, as well as within the agricultural and biotechnology sectors. While endolysins show promising results within the laboratory, it is important to document their resistance, safety, and immunogenicity for in-vivo application.
  • 2.0K
  • 24 Mar 2021
Topic Review
Smart Nanomaterials for Biomedical Applications
Recent advances in nanotechnology have forced the obtaining of new materials with multiple functionalities. Due to their reduced dimensions, nanomaterials exhibit outstanding physio-chemical functionalities: increased absorption and reactivity, higher surface area, molar extinction coefficients, tunable plasmonic properties, quantum effects, and magnetic and photo properties. However, in the biomedical field, it is still difficult to use tools made of nanomaterials for better therapeutics due to their limitations (including non-biocompatible, poor photostabilities, low targeting capacity, rapid renal clearance, side effects on other organs, insufficient cellular uptake, and small blood retention), so other types with controlled abilities must be developed, called “smart” nanomaterials.
  • 1.2K
  • 24 Feb 2021
Topic Review
Filamentous Bacteriophage for Immunotherapeutic Strategies
The pharmaceutical use of bacteriophages as safe and inexpensive therapeutic tools is collecting renewed interest. The use of lytic phages to fight antibiotic-resistant bacterial strains is pursued in academic and industrial projects and is the object of several clinical trials. On the other hand, filamentous bacteriophages used for the phage display technology can also have diagnostic and therapeutic applications. Filamentous bacteriophages are nature-made nanoparticles useful for their size, the capability to enter blood vessels, and the capacity of high-density antigen expression. In the last decades, filamentous bacteriophage ‘fd’ was employed as antigen delivery system, able to trigger all arms of the immune response, with particular emphasis on the ability of the MHC class I restricted antigenic determinants displayed on phages to induce strong and protective cytotoxic responses.Moreover, fd bacteriophages, engineered to target mouse dendritic cells (DCs), activate innate and adaptive responses without the need of exogenous adjuvants, and more recently was employed for the display of immunologically active lipids.
  • 1.1K
  • 20 Feb 2021
Topic Review
Polymer–Lipid Pharmaceutical Nanocarriers
Some issues in pharmaceutical therapies such as instability, poor membrane permeability, and bi-oavailability of drugs can be solved by the design of suitable delivery systems based on the com-bination of two pillar classes of ingredients: polymers and lipids. At the same time, modern tech-nologies are required to overcome production limitations (low productivity, high energy con-sumption, expensive setup, long process times) to pass at the industrial level.
  • 1.3K
  • 19 Feb 2021
Topic Review
Chitosan in Metal Nanoparticles Synthesis
Chitosan (CS) has been widely used as a surface coating for metal nanoparticles. CS can work as a reducing agent, a shape director, or a size-controllable agent in the synthesis of metal nanoparticles. The previous studies have shown that functionalizing the surface of metal nanoparticles by CS can offer many advantages, including improving physicochemical stability, a drug carrier, controlling drug release, promoting muco-adhesiveness and tissue penetration, encouraging cell interactions, and enhancing antimicrobial effects.
  • 1.3K
  • 19 Feb 2021
Topic Review
Informing Patients about Biosimilar Medicines
Biosimilar medicines support the sustainability of national healthcare systems, by reducing costs of biological therapies through increased competition. However, their adoption into clinical practice largely depends on the acceptance of healthcare providers and patients. Patients are different from health care professionals (HCPs), who are informing themselves professionally. For patients, the biosimilar debate only becomes actual when they are confronted with disease and drug choices. 
  • 837
  • 24 Feb 2021
Topic Review
β-Glucan
β-glucans are complex polysaccharides that are found in several plants and foods, including mushrooms. β-glucans display an array of potentially therapeutic properties. 
  • 3.9K
  • 07 Feb 2021
Topic Review
Edible Artemisia: Health Effects
The Artemisia species, often known collectively as "wormwood" are herbs and shrubs, which could be perennial, biennial and annual plants, distributed on all continents except Antarctica, mainly on Northern Hemisphere, with only 25 species on the Southern Hemisphere, being the Asian the zone where higher species diversity is concentrated. The use of Artemisia species in traditional medicine is well-documented and demonstrates the great ethnopharmacological value of this genus. In addition to the traditional medicine applications, Artemisia species exhibit high food value since many of them are species used in culinary as a food, spices, condiments and beverages flavoring.
  • 5.5K
  • 06 Feb 2021
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