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
Immune Checkpoint Inhibitor Targets and Therapies
Immune checkpoint inhibitor (ICI) therapy has revolutionized the treatment of many cancer types, including head and neck cancers (HNC). When checkpoint and partner proteins bind, these send an “off” signal to T cells, which prevents the immune system from destroying tumor cells. Immune checkpoint inhibitor (ICI) therapy has revolutionized the treatment of many cancer types, including head and neck cancers (HNC).
  • 892
  • 27 Jul 2023
Topic Review
The Antioxidant Activity of Mistletoes
In addition to the European mistletoe, Viscum album, which is the most known and utilized one, there are several species commonly known as mistletoe. They are spread in various regions of the planet and are all characterized by hemiparasitism and epiphytic behaviour. The published studies evidence other similarities, including the sharing of important biological properties, with the common presence of antioxidant effects. Mistletoe is an example of the importance of the phytochemical and pharmacological research to update knowledge and utilization of medicinal plants. There are tendencies to limit to use of products derived from natural products, based on prejudices or wrong interpretation. The correct utilization of scientific results is necessary.
  • 1.1K
  • 27 Jul 2023
Topic Review
Inflammatory Bowel Disease-Associated Colorectal Cancer
Colonic inflammatory bowel disease (IBD) encompasses ulcerative colitis (UC) and Crohn’s colitis (CC). Patients with IBD are at increased risk for colitis-associated colorectal cancer (CACRC) compared to the general population. CACRC is preceded by IBD, characterized by highly heterogenous, pharmacologically incurable, pertinacious, worsening, and immune-mediated inflammatory pathologies of the colon and rectum. The molecular and immunological basis of CACRC is highly correlated with the duration and severity of inflammation, which is influenced by the exogenous free hemoglobin alpha chain (HbαC), a byproduct of infiltrating immune cells; extravasated erythrocytes; and macrophage erythrophagocytosis. The exogenous free HbαC prompts oxygen free radical-arbitrated DNA damage (DNAD) through increased cellular reactive oxygen species (ROS), which is exacerbated by decreased tissue antioxidant defenses. Mitigation of the Fenton Reaction via pharmaceutical therapy would attenuate ROS, promote apoptosis and DNAD repair, and subsequently prevent the incidence of CACRC. Three pharmaceutical options that attenuate hemoglobin toxicity include haptoglobin, deferoxamine, and flavonoids (vitamins C/E). Haptoglobin’s clearance rate from plasma is inversely correlated with its size; the smaller the size, the faster the clearance. Thus, the administration of Hp1-1 may prove to be beneficial.
  • 1.4K
  • 13 Jul 2023
Topic Review
Applications of Smart Drug Delivery Devices
The internet of things (IoT) plays a vital role in smart drug delivery systems. It is an emerging field that offers promising solutions for improving the efficacy, safety, and patient compliance of drug therapies. IoT-based drug delivery systems leverage advanced devices, sophisticated sensors, and smart tools to monitor and analyse the health matrices of the patient in real-time, allowing for personalised and targeted drug delivery. This technology is implemented through various types of devices, including wearable and implantable devices such as infusion pumps, smart pens, inhalers, and auto-injectors. However, the development and implementation of IoT-based drug delivery systems pose several challenges, such as ensuring data security and privacy, regulatory compliance, compatibility, and reliability.
  • 2.5K
  • 10 Jul 2023
Topic Review
Antibody–Drug Conjugates for Non-Oncological Applications
Typically, antibody–drug conjugates (ADCs) are made up of a humanized antibody and a small-molecule medication connected by a chemical linker. ADCs’ ability to deliver cytotoxic agents to the specific site with reduced side effects showed promising results in oncology. Inspired by these outcomes, scientists explored the potential of antibody–drug conjugates in non-oncological conditions such as arthritis, myasthenia gravis, immunological disorders, and kidney failure. 
  • 2.0K
  • 07 Jul 2023
Topic Review
Nanotechnology-Based Topical Delivery of Natural Products for AD
Atopic dermatitis (AD) is a chronic eczematous inflammatory disease that may arise from environmental, genetic, and immunological factors. Despite the efficacy of current treatment options such as corticosteroids, such approaches are mainly focused on symptom relief and may present certain undesirable side effects. Isolated natural compounds, oils, mixtures, and/or extracts have gained scientific attention because of their high efficiency and moderate to low toxicity.
  • 1.7K
  • 07 Jul 2023
Topic Review
Overview of Ocular Delivery Systems
Many disorders of the anterior region of the eye may be efficiently treated via topical administration; however, it is more challenging to target conventional therapeutic doses to the posterior of the eye in this manner. Thus, various nanocarriers have been created and investigated for the transport of drugs and genes to the anterior or the posterior portions of the eyes. Liposomes, nanoparticles, micelles, inserts, implants, hydrogel, and emulsions are some of the most frequently utilized drug delivery systems.
  • 2.0K
  • 03 Jul 2023
Topic Review
Targeted Microbubbles for Immunotherapy Applications
Microbubbles are 1–10 μm diameter gas-filled acoustically-active particles, typically stabilized by a phospholipid monolayer shell. In cancer immunotherapy, the microbubble shell can be engineered through the bioconjugation of molecular ligands to facilitate the delivery and uptake of drugs, genes, or cells. This approach allows for precise control of immune stimulation and improves the delivery and pharmacokinetics of immunomodulatory agents at the target site. It has emerged as an attractive strategy for treating various cancer immunotherapy modalities, including monoclonal antibodies, immune checkpoint inhibitors, adoptive cell transfer, cytokine therapy, and vaccines.
  • 1.1K
  • 20 Jun 2023
Topic Review
Significance of microRNAs in Cardiovascular Diseases
The microRNAs (miRNAs), lncRNAs (long ncRNAs), and circRNAs (circular RNAs) with significant regulatory and structural roles make up approximately 99% of the human genome, which does not contain proteins. Non-coding RNAs (ncRNA) have been discovered to be essential novel regulators of cardiovascular risk factors and cellular processes, making them significant prospects for advanced diagnostics and prognosis evaluation. Cases of cardiovascular diseases (CVDs) are rising due to limitations in the existing therapeutic approach; most of the treatment options are based on the coding transcripts that encode proteins. Various investigations have shown the role of nc-RNA in the early diagnosis and treatment of CVDs. Furthermore, the development of novel diagnoses and treatments based on miRNAs, lncRNAs, and circRNAs could be more helpful in the clinical management of patients with CVDs. 
  • 1.2K
  • 21 Jun 2023
Topic Review
Effect of Curcumin Consumption on Inflammation/Oxidative Stress
Advanced chronic kidney disease (CKD) stages lead to exacerbated inflammation and oxidative stress. Patients with CKD in stage 5 need renal hemodialysis (HD) to remove toxins and waste products. However, this renal replacement therapy (RRT) is inefficient in controlling inflammation. Regular curcumin consumption has been shown to reduce inflammation and oxidative stress in subjects with chronic pathologies, suggesting that the daily intake of curcumin may alleviate these conditions in HD patients.
  • 1.1K
  • 26 Jun 2023
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