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
Cell Culture Model in Lung Cancer
2D cell culture provides valuable information on how therapeutic agents act on tumor cells, it cannot quantify how the tumor microenvironment influences the response to therapy.
  • 316
  • 23 Oct 2023
Topic Review
Mechanisms of Antibody Uptake into Central Nervous System
Antibodies (mAbs) are attractive molecules for their application as a diagnostic and therapeutic agent for diseases of the central nervous system (CNS). mAbs can be generated to have high affinity and specificity to target molecules in the CNS. Unfortunately, only a very small number of mAbs have been specifically developed and approved for neurological indications. This is primarily attributed to their low exposure within the CNS, hindering their ability to reach and effectively engage their potential targets in the brain.
  • 301
  • 18 Oct 2023
Topic Review
Molybdenum Disulfide Biosensor for Cancer Biomarker Detection
Molybdenum disulfide (MoS2) is a promising two-dimensional (2D) nanomaterial, whose unique adjustable bandgap shows excellent electronic and optical properties in the construction of biosensor interfaces. It not only has the advantages of a high catalytic activity and low manufacturing costs, but it can also further expand the application of hybrid structures through different functionalization, and it is widely used in various biosensors fields. 
  • 403
  • 11 Oct 2023
Topic Review
Health-Promoting Effects of Bioactive Compounds from Endophytic Fungi
The study examines the intricate relationship between plants and the endophytic fungi inhabiting their tissues. These fungi harmoniously coexist with plants, forming a distinct symbiotic connection that has caught scientific attention due to its potential implications for plant health and growth. The diverse range of bioactive compounds produced by these fungi holds significant promise for human health.
  • 445
  • 09 Oct 2023
Topic Review
Local Antibiotic Carriers in Prosthetic Joint Infection
Prosthetic Joint Infection (PJI) causes significant morbidity and mortality for patients globally. Delivery of antibiotics to the site of infection has potential to improve the treatment outcomes and enhance biofilm eradication. These antibiotics can be delivered using an intra-articular catheter or combined with a carrier substance to enhance pharmacokinetic properties. Use of an antibiotic carrier is an alternative method of maintaining high local concentrations of antibiotic without systemic exposure. These substances incorporate an antimicrobial to prolong its half-life and provide predictable elution characteristics. They may also serve additional roles, such as filling dead space and providing mechanical support for limb alignment. The ideal antibiotic carrier would provide prolonged antibiotic concentrations at an effective level and achieve complete antibiotic release to minimise subtherapeutic elution time. It would also be versatile and have compatibility with the desired antibiotics, and fully resorbable with minimal risk of allergies, and systemic or local adverse effects.
  • 402
  • 25 Sep 2023
Topic Review
Methods in Drug Combination Prediction
The prediction of drug combinations is of great clinical significance. In many diseases, such as high blood pressure, diabetes, and stomach ulcers, the simultaneous use of two or more drugs has shown clear efficacy. It has greatly reduced the progression of drug resistance. 
  • 221
  • 22 Sep 2023
Topic Review
Multifaceted Roles of Gold Nanoparticles
Gold nanoparticles (GNPs) have been recently applied for various diagnostic and therapeutic purposes. The unique properties of these nanoparticles (NPs), such as relative ease of synthesis in various sizes, shapes and charges, stability, high drug-loading capacity and relative availability for modification accompanied by non-cytotoxicity and biocompatibility, make them an ideal field of research in bio-nanotechnology. Moreover, their potential to alleviate various inflammatory factors, nitrite species, and reactive oxygen production and the capacity to deliver therapeutic agents has attracted attention for further studies in inflammatory and autoimmune disorders. Furthermore, the characteristics of GNPs and surface modification can modulate their toxicity, biodistribution, biocompatibility, and effects. 
  • 383
  • 20 Sep 2023
Topic Review
Innovative Therapies for Wound Healing
Wound healing is divided into four overlapping phases: hemostasis, inflammation, proliferation, and remodeling/maturation. During hemostasis, endothelial cells secrete the von Willebrand factor, favoring the adhesion of platelets, which release mediators. During the inflammatory phase mast cells promote vasodilation by the secretion of histamine or serotonin. During the proliferative phase, fibroblasts, in addition to being involved in the formation of granulation tissue, are involved both in the regulation of keratinocyte migration and proliferation other than in angiogenesis. The main processes that distinguish the maturation (or remodeling) phase are collagen restoration and wound contraction, the latter due to myofibroblasts originating from the fibroblasts.
  • 698
  • 19 Sep 2023
Topic Review
Targeted Strategies for Degradation of Key Transmembrane Proteins in Cancer
Targeted protein degradation is an attractive technology for cancer treatment due to its ability to overcome the unpredictability of the small molecule inhibitors that cause resistance mutations. Various targeted protein degradation strategies have been developed based on the ubiquitin–proteasome system in the cytoplasm or the autophagy–lysosomal system during endocytosis. Here describe technologies for the targeted inhibition and targeted degradation of the epidermal growth factor receptor (EGFR), one of the major transmembrane proteins responsible for the onset and progression of many types of cancer.
  • 369
  • 21 Sep 2023
Topic Review
Nefroprotective Potential of Amazonian Plant Species
There are several Amazonian plant species with potential pharmacological validation for the treatment of acute kidney injury, a condition in which the kidneys are unable to adequately filter the blood, resulting in the accumulation of toxins and waste in the body. 
  • 273
  • 14 Sep 2023
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