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
Advancing Regenerative Cellular Therapies in Non-Scarring Alopecia
Alopecia or baldness is a common diagnosis in clinical practice. Alopecia can be scarring or non-scarring, diffuse or patchy. The most prevalent type of alopecia is non-scarring alopecia, with the majority of cases being androgenetic alopecia (AGA) or alopecia areata (AA). AGA is traditionally treated with minoxidil and finasteride, while AA is treated with immune modulators; however, both treatments have significant downsides.
  • 531
  • 08 Aug 2023
Topic Review
Dysregulation of mir-106a in Non-Cancer Diseases
MicroRNAs (miRNAs) comprise a class of non-coding RNA with extensive regulatory functions within cells. MiR-106a is recognized for its super-regulatory roles in vital processes. MicroRNAs (miRNAs) are small, endogenous, non-coding RNAs that control gene expression at the translation and even transcription levels. miRNAs are critical regulators of biological processes, including cellular proliferation, differentiation, development, apoptosis, and modulation of the host response to viral infection.
  • 339
  • 03 Aug 2023
Topic Review
Isolated Marine Compounds with Antifungal Activity
The oceans represent the largest ecosystem on earth, with a high diversity of organisms. Oceans have received some attention, and promising compounds with antimicrobial activities were isolated from marine organisms such as bacteria, fungi, algae, sea cucumbers, sea sponges, etc. 
  • 449
  • 02 Aug 2023
Topic Review
Lipid-Based Delivery Systems for Flavonoids and Flavonolignans
Herbal chemicals with a long history in medicine have attracted a lot of attention. Flavonolignans and flavonoids are considered as two classes of the above-mentioned compounds with different functional groups which exhibit several therapeutic capabilities such as antimicrobial, anti-inflammatory, antioxidant, antidiabetic, and anticancer activities. Based on the studies, high hydrophobic properties of the aforementioned compounds limit their bioavailability inside the human body and restrict their wide application. Nanoscale formulations such as solid lipid nanoparticles, liposomes, and other types of lipid-based delivery systems have been introduced to overcome the above-mentioned challenges. This approach allows the aforementioned hydrophobic therapeutic compounds to be encapsulated between hydrophobic structures, resulting in improving their bioavailability. The above-mentioned enhanced delivery system improves delivery to the targeted sites and reduces the daily required dosage.
  • 519
  • 31 Jul 2023
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).
  • 456
  • 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.
  • 559
  • 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.
  • 621
  • 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.
  • 815
  • 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. 
  • 604
  • 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.
  • 595
  • 07 Jul 2023
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