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
Mechanisms of Carbapenem Resistance
Carbapenem antibiotics are the most effective antimicrobials for the treatment of infections caused by the most resistant bacteria. They belong to the category of β-lactams that include the penicillins, cephalosporins, monobactams and carbapenems. This class of antimicrobials has a broader spectrum of activity than most other beta-lactams antibiotics and are the most effective against Gram-positive and Gram-negative bacteria. All β-lactams antibiotics have a similar molecular structure: the carbapenems together with the β-lactams. 
  • 1.2K
  • 13 Apr 2022
Topic Review
Applications of Nanostructured Materials
In the last few decades, the vast potential of nanomaterials for biomedical and healthcare applications has been extensively investigated. Several case studies demonstrated that nanomaterials can offer solutions to the current challenges of raw materials in the biomedical and healthcare fields. The different nanoparticles and nanostructured material synthesis approaches were described.
  • 5.3K
  • 11 Apr 2022
Topic Review
Ganoderma lucidum
Ganoderma lucidum has a long history of medicinal uses in the Far East countries of more than 2000 years due to its healing properties. Recently, G. lucidum has come under scientific scrutiny to evaluate its content of bioactive components that affect human physiology and has been exploited for potent components in the pharmacology, nutraceuticals, and cosmetics industries. For instance, evidence is accumulating on the potential of this mushroom species as a promising antiviral medicine for treating many viral diseases, such as dengue virus, enterovirus 71, and recently coronavirus disease of 2019 (COVID-19). Still, more research studies on the biotherapeutic components of G. lucidum are needed to ensure the safety and efficiency of G. lucidum and promote the development of commercial functional foods.
  • 3.0K
  • 11 Apr 2022
Topic Review
Nanoparticles-Loaded Hydrogel System
Hydrogels are three-dimensional porous structures produced with hydrophilic polymers through physical or chemical cross-linking methods and can be prepared from a wide range of natural and synthetic polymers. Nanoparticles (NPs) are colloidal structures designed and produced to transport drugs across biological barriers. Their optimal size range is approximately between 100 and 200 nm. They protect drugs from degradation, increasing their half-life, improving drugs’ bioavailability, and providing a sustained and localized release.
  • 2.2K
  • 07 Apr 2022
Topic Review
Silk Fibroin-Based Therapeutics
Silk fibroin, the fibrous structural-protein component in silk, has emerged as a promising treatment for these impaired processes by promoting functional tissue regeneration. Silk fibroin’s dynamic properties allow for customizable nanoarchitectures, which can be tailored for effectively treating several wound healing impairments. Different forms of silk fibroin include nanoparticles, biosensors, tissue scaffolds, wound dressings, and novel drug-delivery systems. Silk fibroin can be combined with other biomaterials, such as chitosan or microRNA-bound cerium oxide nanoparticles (CNP), to have a synergistic effect on improving impaired wound healing.
  • 1.2K
  • 01 Apr 2022
Topic Review
Two-Dimensional Nanomaterials for Biomedical Applications
Two-dimensional nanomaterials (2DNMs) received remarkable attention in nanomedicine as a class of new nanomaterials in recent years. 2DNMs, which range from nanometer to micrometer scales, have one or a few atomic thicknesses and are one of the most promising materials for biomedical applications owing to their special structure and unique properties.
  • 1.1K
  • 01 Apr 2022
Topic Review
Bioactive Glasses in Periodontal Regeneration
Bioactive glasses (BGs) were discovered by Larry L. Hench in 1969; the original composition, named Bioglass® 45S5 (45S5 from here on), displayed outstanding properties such as bone regeneration capabilities and antibacterial activity. In fact, such BG is an amorphous and biocompatible silica oxide-based inorganic material able to induce surface property responses resulting in the formation of a bond between the bone and the glass itself. In general, the surface of BGs, when soaked in physiological fluids, undergoes a complex ion exchange mechanism with the medium, inducing the formation of precipitates and subsequently hydroxyapatite deposition. This mechanism could explain the effectiveness of these BGs to bind to bones and the wide number of studies on BGs as supporting materials for bone tissue engineering and tooth remineralization.
  • 1.2K
  • 01 Apr 2022
Topic Review
Poly(Lactic-Co-Glycolic Acid)-Gold Nanoparticles
A composite system consisting of both organic and inorganic nanoparticles is an approach to prepare a new material exhibiting “the best of both worlds”. With the current clinically use of poly(lactic-co-glycolic acid)-gold nanoparticles (PLGA-GNP), PLGA-based nanocarriers have promising pharmaceutical applications and can “extract and utilize” the fascinating optical and photothermal properties of encapsulated GNP. The resulting “golden polymeric nanocarrier” can be tracked, analyzed, and visualized using the encapsulated gold nanoprobes which facilitate a better understanding of the hosting nanocarrier’s pharmacokinetics and biological fate. In addition, the “golden polymeric nanocarrier” can reveal superior nanotherapeutics that combine both the photothermal effect of the encapsulated gold nanoparticles and co-loaded chemotherapeutics. 
  • 1.0K
  • 07 Apr 2022
Topic Review
Architectures of Polyacrylic Acid
Polyacrylic acid (PAA) is a non-toxic, biocompatible, and biodegradable polymer that gained lots of interest in recent years. PAA nano-derivatives can be obtained by chemical modification of carboxyl groups with superior chemical properties in comparison to unmodified PAA.
  • 1.9K
  • 01 Apr 2022
Topic Review
Recombinant Pichinde Virus-Vectored Turkey Arthritis Reovirus Subunit Vaccine
Turkey arthritis reovirus (TARV) causes lameness in turkeys, generally at 12–17 weeks of age. A recombinant live pichinde virus-vectored bivalent codon optimized subunit vaccine that expresses immunogenic Sigma C and Sigma B proteins of turkey arthritis reovirus was created. The vaccine virus could be transmitted horizontally immunizing the non-vaccinated pen mates. Comparison of virus gene copy numbers in intestine and histologic lesion scores in tendons of vaccinated and non-vaccinated birds showed a decrease in the replication of challenge viruses in the intestine and tendons of vaccinated birds. These results indicate the potential usefulness of this vaccine.
  • 895
  • 28 Mar 2022
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