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
Chromatin-Remodeling in Cancer Cells
ATP-dependent chromatin-remodeling complexes can reorganize and remodel chromatin and thereby act as important regulator in various cellular processes. Based on considerable studies over the past two decades, it has been confirmed that the abnormal function of chromatin remodeling plays a pivotal role in genome reprogramming for oncogenesis in cancer development and/or resistance to cancer therapy.
  • 594
  • 11 Nov 2022
Topic Review
Exosomes for Drug Delivery
Particular interest among the scientific community is focused on exploring the use of exosomes for several pharmaceutical and biomedical applications. This is due to the identification of the role of exosomes as an excellent intercellular communicator by delivering the requisite cargo comprising of functional proteins, metabolites and nucleic acids. Exosomes are the smallest extracellular vesicles (EV) with sizes ranging from 30–100 nm and are derived from endosomes. Exosomes have similar surface morphology to cells and act as a signal transduction channel between cells. They encompass different biomolecules, such as proteins, nucleic acids and lipids, thus rendering them naturally as an attractive drug delivery vehicle. Like the other advanced drug delivery systems, such as polymeric nanoparticles and liposomes to encapsulate drug substances, exosomes also gained much attention in enhancing therapeutic activity. Exosomes present many advantages, such as compatibility with living tissues, low toxicity, extended blood circulation, capability to pass contents from one cell to another, non-immunogenic and special targeting of various cells, making them an excellent therapeutic carrier. Exosome-based molecules for drug delivery are still in the early stages of research and clinical trials. The problems and clinical transition issues related to exosome-based drugs need to be overcome using advanced tools for better understanding and systemic evaluation of exosomes.
  • 759
  • 21 Nov 2022
Topic Review
Cyclotide Scaffold for Targeting Biomolecular Interactions
The selective disruption of protein–protein interactions remains challenging, as the interacting surfaces are relatively large and flat. However, highly constrained polypeptide-based molecular frameworks with cell-permeability properties, such as the cyclotide scaffold, have shown great promise for targeting those biomolecular interactions. 
  • 427
  • 10 Nov 2022
Topic Review
Drug Carriers for Arthritis Therapy
Drug carriers are used to penetrate the biological barriers and deliver the requisite active pharmaceutical ingredients (API). This has greater significance for medication in arthritis therapies because the inflammatory progression of rheumatoid arthritis (RA) and osteoarthritis (OA) is complex, intertwined, and influenced by one another. For this purpose, the drug delivery systems (DDS) of this carrier are currently being investigated with exogenous triggers and endogenous stimuli. This flexible-release invention will solve the problems of multiple implantations and local toxic accumulation at the lesion sites.
  • 753
  • 10 Nov 2022
Topic Review
Pharmacogenetics of Dox Metabolism
The effectiveness and safety of the anti-cancer agent doxorubicin (Dox) (anthracycline group medicine) depend on the metabolism and retention of the drug in the human organism. Polymorphism of cytochrome p450 (CYP)-encoding genes and detoxifying enzymes such as CYP3A4 and CYP2D6 were found responsible for variations in the doxorubicin metabolism. Transmembrane transporters such as p-glycoproteins were reported to be involved in cancer tissue retention of doxorubicin. The metabolic transformation of Dox may follow several pathways, including two-electron reduction with the formation of doxorubicinol, one-electron reduction with the formation of semiquinone, and deglycosylation with the formation of aglycone. Several enzymes have been shown to be involved in this process. Doxorubicinol is considered the most dangerous metabolite of Dox degradation, as it may disturb iron and calcium balances.
  • 454
  • 09 Nov 2022
Topic Review
Heterocyclic PPAR Ligands for Potential Therapeutic Applications
The family of nuclear peroxisome proliferator-activated receptors (PPARα, PPARβ/δ, and PPARγ) is a set of ligand-activated transcription factors that regulate different functions in the body. Whereas activation of PPARα is known to reduce the levels of circulating triglycerides and regulate energy homeostasis, the activation of PPARγ brings about insulin sensitization and increases the metabolism of glucose. On the other hand, PPARβ when activated increases the metabolism of fatty acids. Further, these PPARs have been claimed to be utilized in various metabolic, neurological, and inflammatory diseases, neurodegenerative disorders, fertility or reproduction, pain, and obesity.
  • 584
  • 08 Nov 2022
Topic Review
Immunomodulating Hydrogels for Drug Delivery Applications
One of the most concerning issues with conventional drug delivery platforms is the elicitation of an immune response upon implantation. Different natural and artificial platforms have been used for various biomedical applications ranging from drug and metabolite delivery, gene delivery, and wound healing/regenerative applications. However, most of these platforms suffer due to a compromise on immunogenicity and their respective biomedical applications. Although hydrogels from biomaterials of different origins have shown great promise in various biomedical applications, their immunogenicity, however small, is still a matter of concern, thus preventing their widespread clinical adoption. Hydrogels have been proposed as an excellent platform for various applications in drug delivery and regenerative medicine. Hydrogels are soft, tridimensional crosslinked networks of polymers with a high-water content, similar to the percentage found in human tissue.
  • 667
  • 04 Nov 2022
Topic Review
Physiologically Based Pharmacokinetic Modeling of Nanoparticle Biodistribution
Cancer treatment and pharmaceutical development require targeted treatment and less toxic therapeutic intervention to achieve real progress against this disease. In this scenario, nanomedicine emerged as a reliable tool to improve drug pharmacokinetics and to translate to the clinical biologics based on large molecules. However, the ability of body to recognize foreign objects together with carrier transport heterogeneity derived from the combination of particle physical and chemical properties, payload and surface modification, make the designing of effective carriers very difficult. In this scenario, physiologically based pharmacokinetic modeling can help to design the particles and eventually predict their ability to reach the target and treat the tumor. This effort is performed by scientists with specific expertise and skills and familiarity with artificial intelligence tools such as advanced software that are not usually in the “cords” of traditional medical or material researchers. 
  • 636
  • 04 Nov 2022
Topic Review
Glycation-Associated Diabetic Nephropathy and Long Noncoding RNAs
The glycation of various biomolecules is the root cause of many pathological conditions associated with diabetic nephropathy and end-stage kidney disease. Glycation imbalances metabolism and increases renal cell injury. Numerous therapeutic measures have narrowed down the adverse effects of endogenous glycation, but efficient and potent measures are miles away. Recent advances in the identification and characterization of noncoding RNAs, especially the long noncoding RNAs (lncRNAs), have opened a mammon of new biology to explore the mitigations for glycation-associated diabetic nephropathy. Furthermore, tissue-specific distribution and condition-specific expression make lncRNA a promising key for second-generation therapeutic interventions.
  • 470
  • 03 Nov 2022
Topic Review
CD40 as Therapeutic Target
Targeting of CD40 with the aim to stimulate or inhibit this receptor attracts considerable translational interest. Inhibitory CD40 targeting appears particularly attractive in the field of organ transplantation and in the treatment of autoimmune diseases. CD40 blockade might also elicit antitumoral activity on CD40-expressing tumors. Agonistic CD40 targeting typically aims at the exploitation of the strong immunostimulatory activities of CD40 for tumor immunotherapy and vaccination against various infectious pathogens.
  • 727
  • 03 Nov 2022
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