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
Plant Extracts-Based Nanocarriers for anticancer therapy
Nanocarriers enhance the dissolution and bioavailability of drugs and facilitate their targeting effect. Taking the potential toxicity into consideration, the incorporation of natural “green” materials, derived from plants, in the nanocarriers fabrication, improve their safety and biocompatibility. These green components can be used as mechanical platforms, targeting ligands or can play be involved in the synthesis of nanoparticles. 
  • 484
  • 20 Dec 2021
Topic Review
Antimicrobial Resistance and Inorganic Nanoparticles
A bacterium becomes resistant due to the transfer of genes encoding antibiotic resistance. Bacteria constantly mutate; therefore, their defense mechanisms change constantly.  Nanotechnology plays a key role in antimicrobial resistance due to materials modified at the nanometer scale, allowing large numbers of molecules to assemble to have a dynamic interface. These nanomaterials act as carriers, and their design is mainly focused on introducing the temporal and spatial release of the payload of antibiotics. In addition, they generate new antimicrobial modalities for the bacteria, which are not capable of protecting themselves.
  • 693
  • 18 Dec 2021
Topic Review
Reproducibility Evaluation of Urinary Peptide Detection Using CE-MS
In recent years, capillary electrophoresis coupled to mass spectrometry (CE-MS) has been increasingly applied in clinical research especially in the context of chronic and age-associated diseases, such as chronic kidney disease, heart failure and cancer. Biomarkers identified using this technique are already used for diagnosis, prognosis and monitoring of these complex diseases, as well as patient stratification in clinical trials. CE-MS allows for a comprehensive assessment of small molecular weight proteins and peptides (<20 kDa) through the combination of the high resolution and reproducibility of CE and the distinct sensitivity of MS, in a high-throughput system. In this study we assessed CE-MS analytical performance with regards to its inter- and intra-day reproducibility, variability and efficiency in peptide detection, along with a characterization of the urinary peptidome content. To this end, CE-MS performance was evaluated based on 72 measurements of a standard urine sample (60 for inter- and 12 for intra-day assessment) analyzed during the second quarter of 2021. Analysis was performed per run, per peptide, as well as at the level of biomarker panels. The obtained datasets showed high correlation between the different runs, low variation of the ten highest average individual log2 signal intensities (coefficient of variation, CV < 10%) and very low variation of biomarker panels applied (CV close to 1%). The findings of the study support the analytical performance of CE-MS, underlining its value for clinical application.
  • 329
  • 17 Dec 2021
Topic Review
Tissue Engineering of the Urethra—Clinical Applications
Tissue engineering (TE) is a promising approach for repair/substitution of damaged tissues and organs. Urethral strictures are common and serious health conditions that impair quality of life and may lead to serious organ damage. The TE approach is promising and effective, but many issues remain that need to be addressed for broader adoption of TE in urethral repair. Better design of trials, better cooperation of research groups and centralization could lead to reduction of costs and slowly proceed to commercialization and routine use of TE products for urethral reconstruction.
  • 486
  • 23 Dec 2021
Topic Review
Protein-Based Systems for Translational Regulation of synthetic mRNAs
Synthetic mRNAs, which are produced by in vitro transcription, have been recently attracting attention because they can express any transgenes without the risk of insertional mutagenesis. Protein-based translational regulation systems enable the context-dependent production of therapeutic proteins and have the potential to further improve the efficacy and safety of synthetic mRNAs.
  • 519
  • 17 Dec 2021
Topic Review
A Structural Approach to Anti-Virulence
The anti-virulence strategy is designed to prevent bacterial virulence factors produced by pathogenic bacteria from initiating and sustaining an infection. 
  • 677
  • 16 Dec 2021
Topic Review
Spicules-Based Topical Delivery Systems
Sponge spicules have recently been utilized as scattered microneedles to disrupt the skin barrier and enhance the skin penetration of a series of therapeutics and even nanoparticles. Spicules can physically disrupt skin in a dose-dependent manner and be retained within the skin over a long time, which provides a convenient, safe, and effective skin delivery strategy.
  • 585
  • 16 Dec 2021
Topic Review
Egyptian Carob Pods (Ceratonia siliqua L.) Aqueous Extract
Ceratonia siliqua (Carob) is an evergreen Mediterranean tree, and carob pods are potentially nutritive and have medicinal value. 
  • 523
  • 15 Dec 2021
Topic Review
Cell Penetrating Peptides
Cell-penetrating peptides (CPPs) are peptides that can directly adapt to cell membranes and then permeate into cells. They are usually cationic for the electronic interactions between CPPs and anionic cell membrane. Meanwhile, some of them can target a specific protein at the same time. In nanomedicine, as an element, CPPs are usually covalently linked to the surface of nanocarriers to endow their permeability to the whole system.
  • 589
  • 14 Dec 2021
Topic Review
Mesenchymal Stem Cell-Derived Extracellular Vesicle and Osteoporosis
Osteoporosis, a metabolic skeletal disorder that results from the imbalance between bone formation and bone resorption, generally occurs in postmenopausal women and older people. The process of bone remodeling is participated by mainly osteoclasts and osteoblasts, together with other cells including osteocytes, bone lining cells, monocytes, chondrocytes, hematopoietic stem cells, and mesenchymal stem cells (MSCs).
  • 523
  • 14 Dec 2021
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