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
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.
  • 1.1K
  • 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.
  • 1.3K
  • 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.
  • 1.2K
  • 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. 
  • 1.5K
  • 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.
  • 988
  • 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.
  • 1.4K
  • 03 Nov 2022
Topic Review
Combination Therapy for Glioblastoma
Aggressive glioblastoma (GBM) has no known treatment as a primary brain tumor. Since the cancer is so heterogeneous, an immunosuppressive tumor microenvironment (TME) exists, and the blood–brain barrier (BBB) prevents chemotherapeutic chemicals from reaching the central nervous system (CNS), therapeutic success for GBM has been restricted. Drug delivery based on nanocarriers and nanotechnology has the potential to be a handy tool in the continuing effort to combat the challenges of treating GBM. Combination therapies may be enhanced by using nanotechnology-based delivery techniques. Nano-chemotherapy, nano-chemotherapy–radiation, nano-chemotherapy–phototherapy, and nano-chemotherapy–immunotherapy for GBM.
  • 1.2K
  • 02 Nov 2022
Topic Review
Bio-Inspired Smart Nanoparticles in Oncology
Compared with traditional treatment, nanotechnology offers new therapeutic options for cancer due to its ability to selectively target and control drug release. Among the various routes of nanoparticle synthesis, plants have gained significant recognition. The tremendous potential of medicinal plants in anticancer treatments calls for a comprehensive research of existing studies on plant-based nanoparticles. The research examined various metallic nanoparticles obtained by green synthesis using medicinal plants. Plants contain biomolecules, secondary metabolites, and coenzymes that facilitate the reduction of metal ions into nanoparticles. These nanoparticles are believed to be potential antioxidants and cancer-fighting agents.
  • 1.0K
  • 02 Nov 2022
Topic Review
Photo-Stimuli-Responsive Antibacterial Applications of CuS and Its Nanocomposites
Photo-stimuli-responsive therapeutic nanomaterials have gained widespread attention as frontline materials for biomedical applications. The photoactivation strategies are classified as single-modality (based on either reactive oxygen species (ROS)-based photodynamic therapy (PDT), hyperthermia-based photothermal therapy (PTT)), or dual-modality (which combines PDT and PTT). CuS has excellent photoactivated antibacterial properties and shows promising antibacterial activity when irradiated in the so-called biological window (i.e., NIR region).
  • 1.0K
  • 01 Nov 2022
Topic Review
Bacteria-Based Cancer Treatment
Cancer refers to a disease involving abnormal cells that proliferate uncontrollably and can invade normal body tissue. It was estimated that at least 9 million patients are killed by cancer annually. Recent studies have demonstrated that bacteria play a significant role in cancer treatment and prevention. Owing to its unique mechanism of abundant pathogen-associated molecular patterns in antitumor immune responses and preferentially accumulating and proliferating within tumors, bacteria-based cancer immunotherapy has recently attracted wide attention.
  • 1.1K
  • 31 Oct 2022
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