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
Erythrocytes as Carriers of Therapeutic Enzymes
Therapeutic enzymes are biocatalyst drugs that bind to target substrates with a high affinity and specificity, catalyzing their conversion into their relevant products. The past five decades have seen the development of therapeutic enzymes for treating a wide range of medical conditions, including inherited enzyme deficiency disorders, acute poisoning, digestive disorders, cancer and cardiovascular diseases. Chemical modifications of the native enzyme (e.g., conjugation with polyethylene glycol) are often employed in the manufacturing process to increase protein stability, decrease immunogenicity, reduce renal ultrafiltration and in some cases, to enable targeting of the enzyme to the appropriate cellular compartment. The erythrocyte carrier has been extensively studied as a strategy for overcoming these limitations and increasing therapeutic efficacy. For a majority of the therapeutic applications investigated, the ability of the cell to reseal after creating pores in the membrane has been exploited for the purpose of introducing therapeutic agents.
  • 563
  • 15 Apr 2022
Topic Review
Fluorescence Imaging for Biomedical Applications
Molecular imaging offers the possibility to investigate biological and biochemical processes non-invasively and to obtain information on both anatomy and dysfunctions. Based on the data obtained, a fundamental understanding of various disease processes can be derived and treatment strategies can be planned. In this context, methods that combine several modalities in one probe are increasingly being used. Due to the comparably high sensitivity and provided complementary information, the combination of nuclear and optical probes has taken on a special significance.
  • 528
  • 13 Apr 2022
Topic Review
Extended Myc Network
Among the first discovered and most prominent cellular oncogenes is MYC, which encodes a bHLH-ZIP transcription factor (Myc) that both activates and suppresses numerous genes involved in proliferation, energy production, metabolism and translation. Myc belongs to a small group of bHLH-ZIP transcriptional regulators (the Myc Network) that includes its obligate heterodimerization partner Max and six “Mxd proteins” (Mxd1–4, Mnt and Mga), each of which heterodimerizes with Max and largely opposes Myc’s functions.
  • 523
  • 13 Apr 2022
Topic Review
Biomedical Applications of MXenes
MXenes have emerged as a newer class of 2D materials that produce metallic conductivity upon interaction with hydrophilic species, and their delamination affords monolayer nanoplatelets of a thickness of about one nm and a side size in the micrometer range. Delaminated MXene has a high aspect ratio, making it an alluring nanofiller for multifunctional polymer nanocomposites. Moreover, MXenes are of special relevance in hydrogel-based applications because of their outstanding mechanical strength, extraordinary hydrophilicity and a distinct surface chemistry, which adds a new level of adaptability.
  • 634
  • 15 Apr 2022
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. 
  • 599
  • 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.
  • 3.1K
  • 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.
  • 1.5K
  • 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.
  • 1.2K
  • 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.
  • 510
  • 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.
  • 654
  • 01 Apr 2022
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