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
4D Printable Smart Hydrogels for Drug Delivery
Hydrogels are three-dimensional crosslinked polymer network structures that can absorb and hold a large quantity of water while retaining a distinct shape. Among modern drug formulations, stimuli-responsive hydrogels, also known as "smart hydrogels," has attracted enormous attention. The fundamental characteristic of these systems is the capacity to change their mechanical properties, swelling capacity, hydrophilicity, permeability of bioactive molecules, etc., in response to a wide range of stimuli, including temperature, pH, light irradiation, magnetic field, biological factors, etc. On the other hand, the expeditious development of 3D printing technologies has revolutionized the fabrication of hydrogel systems for biomedical applications. By combining these two aspects, 4D printing (i.e., 3D printing of smart hydrogels) has emerged as a new promising platform for the development of novel drug delivery systems, which release active ingredients in response to internal or external stimuli.
  • 2.1K
  • 01 Nov 2022
Topic Review
PPAR-γ Partial Agonists in Disease-Fate Decision
Peroxisome proliferator-activated receptor-γ (PPAR-γ) has emerged as one of the most extensively studied transcription factors since its discovery in 1990, highlighting its importance in the etiology and treatment of numerous diseases involving various types of cancer, type 2 diabetes mellitus, autoimmune, dermatological and cardiovascular disorders. Ligands are regarded as the key determinant for the tissue-specific activation of PPAR-γ. However, the mechanism governing this process is merely a contradictory debate which is yet to be systematically researched. Either these receptors get weakly activated by endogenous or natural ligands or leads to a direct over-activation process by synthetic ligands, serving as complete full agonists. Therefore, fine-tuning on the action of PPAR-γ and more subtle modulation can be a rewarding approach which might open new avenues for the treatment of several diseases.
  • 1.8K
  • 14 Nov 2022
Topic Review
Metallo-Drugs in Cancer Therapy
Cancer treatments which include conventional chemotherapy have not proven very successful in curing human malignancies. The failures of these treatment modalities include inherent resistance, systemic toxicity and severe side effects. Out of 50% patients administrated to chemotherapy, only 5% survive. 
  • 989
  • 24 Oct 2022
Topic Review
Dostarlimab in Cancer Treatment
Immunotherapy is one of the four pillars of cancer treatment that has emerged as a beacon of hope for cancer patients. Certain immunotherapies, for example, immune checkpoint inhibitor therapy, monoclonal antibody therapy and chimeric antigen T-cell therapy have garnered extensive interest in response to their exceptional properties that activate the immune system to respond to cancer cells, inhibiting their progression. In the era of rapid development, dostarlimab, an anti-programmed cell death protein (PD-1) monoclonal antibody has mesmerized the medical profession by showing complete (100%) cure of patients with colorectal cancer. Not only this, the results obtained from clinical trials revealed no major side effects in any of the participants in the study. Dostarlimab has also shown promising results in endometrial cancer, ovarian cancer, melanoma, head and neck cancer, and breast cancer therapy. 
  • 1.3K
  • 24 Oct 2022
Topic Review
Applications of Mineral-Enriched Postbiotics
Postbiotics are non-viable probiotic preparations that confer a health benefit on the host. Scientific literature has proved that postbiotics have health-promoting features and technological advantages compared to probiotics, augmenting their full potential application in the food and pharmaceutical industries. 
  • 1.3K
  • 21 Oct 2022
Topic Review
Physico-Chemical Properties of Sodium Alginate
The macromolecules of natural origin have attracted the attention of many researchers as essential to protect the structures of unstable drug substances. After analyzing the studies carried out by various authors, researchers found that these molecules are used for both investigational and therapeutic purposes. This requires the design of certain drug delivery formulations knowing the nature of the macromolecule, its target organ, the required dose and the route of delivery. Therefore, researchers consider it important to use sodium alginate to optimize the delivery of drug substances for maximum therapeutic performance in the body after administration.
  • 21.0K
  • 19 Oct 2022
Topic Review
Antimicrobial Effects of Antimicrobial Peptides
The growing emergence of antimicrobial resistance represents a global problem that not only influences healthcare systems but also has grave implications for political and economic processes. As the discovery of novel antimicrobial agents is lagging, one of the solutions is innovative therapeutic options that would expand our armamentarium against this hazard. Compounds of interest in many such studies are antimicrobial peptides (AMPs), which actually represent the host’s first line of defense against pathogens and are involved in innate immunity. They have a broad range of antimicrobial activity against Gram-negative and Gram-positive bacteria, fungi, and viruses, with specific mechanisms of action utilized by different AMPs.
  • 2.2K
  • 18 Oct 2022
Topic Review
SeNPs as Anticancer Agents
It is well known that long-term intake of selenium in excess amounts can have adverse physiological effects on humans. Long-term intake of selenium in excess amounts leads to rapid development of severe gastrointestinal and neurological symptoms, followed by acute respiratory failure, myocardial infarction, and renal failure, and may increase the risk of cancer. The Food and Nutrition Board set a tolerable upper Se intake level (UL) for adults at 400 μg/day. Toxicity testing is an important concern in the improvement in selenium-containing anticancer drugs. Various forms of selenium could serve as pro-oxidant toxic agents and promote DNA strand disruption and necrosis of cancer cells. Among the many types of nanoparticles, SeNPs have selective anticancer activity on cancer cells and low toxicity to normal cells. They exhibit low toxicity, better bioavailability and higher activity as compared to organic and inorganic selenium compounds. In the peritoneal cavity, the clearance rate of SeNPs was slower than in plasma, so they may activate an enhanced drug concentration near the cancer-related peritoneal cavity. Therefore, by maintaining a low total drug level, the use of active doses in the cancer model was expected to be less cause of suspected adverse reactions.
  • 1.0K
  • 18 Oct 2022
Topic Review
DFT Calculations in Designing Polymer-Based Drug Delivery Systems
Drug delivery systems transfer medications to target locations throughout the body. These systems are often made up of biodegradable and bioabsorbable polymers acting as delivery components. The introduction of density functional theory (DFT) has tremendously aided the application of computational material science in the design and development of drug delivery materials. The use of DFT and other computational approaches avoids time-consuming empirical processes.
  • 1.7K
  • 18 Oct 2022
Topic Review
Natural Polymer Nanofibrous Scaffold
Nanofibrous scaffolds mimicking artificial extracellular matrices provide a natural environment for tissue regeneration owing to their large surface area, high porosity, and appreciable drug loading capacity. Electrospun nanofibrous scaffolds have demonstrated promising potential in bone tissue regeneration using a variety of nanomaterials. Natural and synthetic polymeric nanofibrous scaffolds are extensively inspected to regenerate bone tissue. Bone tissue engineering (BTE) procedures make usage of various scaffolds (e.g., composite scaffolds, nanofibrous scaffolds, porous scaffolds, hydrogel scaffolds) in conjunction with biological materials.
  • 799
  • 17 Oct 2022
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