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
Insights and Strategies of Melanoma Immunotherapy
Despite the successes and durable responses with immune checkpoint inhibitors (ICI), many cancer patients, including those with melanoma, do not derive long-term benefits from ICI therapies. The lack of predictive biomarkers to stratify patients to targeted treatments has been the driver of primary treatment failure and represents an unmet medical need in melanoma and other cancers. Understanding genomic correlations with response and resistance to ICI will enhance cancer patients’ benefits. Building on insights into interplay with the complex tumor microenvironment (TME), the ultimate goal should be assessing how the tumor ’instructs’ the local immune system to create its privileged niche with a focus on genomic reprogramming within the TME. It is hypothesized that this genomic reprogramming determines the response to ICI. Furthermore, emerging genomic signatures of ICI response, including those related to neoantigens, antigen presentation, DNA repair, and oncogenic pathways, are gaining momentum. 
  • 379
  • 31 Jan 2023
Topic Review
Optical Biosensing of Cancer Antigen 125
Cancer antigen 125 (CA-125) is a well-known oncomarker in ovarian cancer (OC) that has been widely used. CA-125 is a high-molecular-weight glycoprotein (>200 kDa) generated by normal cells in adult tissues derived from coelomic and Müllerian epithelia. CA-125 levels of less than 35 U/mL in the human body are acceptable for normal cells. Women with advanced stages of OC often show an elevated level of CA-125. Some early-stage cancers can be diagnosed via detecting the cancer antigen CA-125, such as ovarian cancer, and required treatments can be applied more efficiently. Thus, detection of CA-125 by employing various optical or electrochemical biosensors is a preliminary and crucial step to treating cancers. 
  • 339
  • 28 Jan 2023
Topic Review
The Electrohydrodynamic Method for Nanomaterial Production
Electrospinning is a versatile technique used to produce fibrous mats. The high surface area of the electrospun mats makes them suitable for applications in fields using nanoparticles. Electrospun mats are used for tissue engineering, wound dressing, water-treatment filters, biosensors, nanocomposites, medical implants, protective clothing materials, cosmetics, and drug delivery systems. 
  • 327
  • 28 Jan 2023
Topic Review
Enzymatic Biocatalysis for Degradation of Plastic PET
Most Polyethylene terephthalate (PET) degrading enzymes belong to the 3.40.50.1820 superfamily, according to the CATH database, since they share a conserved catalytic domain and assume the typical alpha/beta hydrolase fold. Breaking of PET bonds is typically accomplished by a catalytic triad involving a serine, a histidine and a negatively charged residue, usually an aspartate or a glutamate.
  • 453
  • 29 Jan 2023
Topic Review
Aptamers in Hematologic Malignancies
Aptamer is a targeting tool with many unique advantages (easy synthesis, low toxicity, easy modification, low immunogenicity, nano size, long stability, etc.), therefore many experts screened corresponding aptamers in various hematological malignancies for diagnosis and treatment.
  • 546
  • 19 Jan 2023
Topic Review
Topical and Intradermal Administration in Horse
Horses are companion animals with temperamental and sensitive characteristics that play an important role in the lives of many individuals. Therefore, the global demand and market for equine healthcare products are rapidly increasing. However, comprehensive, and intensive information on drug development relating to equine health is still very much in its infancy. Delivering drugs to horses orally is a major challenge, as the physiology and anatomy of the equine gastro-intestinal tract (GIT) can result in poor bioavailability of some oral drugs. Additionally, due to their size, the dosages required are much larger and higher cost compared to those of humans; with potential of adverse effects, especially for antibiotics, following the administration of some drugs.
  • 396
  • 28 Jan 2023
Topic Review
Chromatin and Cancer
A hallmark of cancers is uncontrolled cell proliferation, frequently associated with an underlying imbalance in gene expression. This transcriptional dysregulation observed in cancers is multifaceted and involves chromosomal rearrangements, chimeric transcription factors, or altered epigenetic marks. Traditionally, chromatin dysregulation in cancers has been considered a downstream effect of driver mutations. Disruption of this large-scale chromatin in proliferating cancerous cells in conventional chemotherapies induces DNA damage and provides a positive feedback loop for chromatin rearrangements and tumor diversification. Consequently, the surviving cells from these chemotherapies become tolerant to higher doses of the therapeutic reagents, which are significantly toxic to normal cells. Furthermore, the disorganization of chromatin induced by these therapies accentuates nuclear fragility, thereby increasing the invasive potential of these tumors.
  • 429
  • 29 Jan 2023
Topic Review
Bionanomaterials Based on Honey and Propolis for wounds
Wound healing is a public health concern worldwide, particularly in chronic wounds due to delayed healing and susceptibility to bacterial infection. Nanomaterials are widely used in wound healing treatments due to their unique properties associated with their size and very large surface-area-to-volume ratio compared to the same material in bulk. The properties of nanomaterials can be expanded and improved upon with the addition of honey and propolis, due to the presence of bioactive molecules such as polyphenols, flavonoids, peptides, and enzymes. These bionanomaterials can act at different stages of wound healing and through different mechanisms, including anti-inflammatory, antimicrobial, antioxidant, collagen synthesis stimulation, cell proliferation, and angiogenic effects.
  • 816
  • 29 Jan 2023
Topic Review
Artificial Intelligence in Fluorescent Nanodiamonds Biomedical Imaging
The ability to precisely monitor the intracellular temperature directly contributes to the essential understanding of biological metabolism, intracellular signaling, thermogenesis, and respiration. The intracellular heat generation and its measurement can also assist in the prediction of the pathogenesis of chronic diseases. Intracellular thermometry without altering the biochemical reactions and cellular membrane damage is challenging, requiring appropriately biocompatible, nontoxic, and efficient biosensors. Bright, photostable, and functionalized fluorescent nanodiamonds (FNDs) have emerged as excellent probes for intracellular thermometry and magnetometry with the spatial resolution on a nanometer scale. The temperature and magnetic field-dependent luminescence of naturally occurring defects in diamonds are key to high-sensitivity biosensing applications. Alterations in the surface chemistry of FNDs and conjugation with polymer, metallic, and magnetic nanoparticles have opened vast possibilities for drug delivery, diagnosis, nanomedicine, and magnetic hyperthermia. The possibilities and outcomes of using AI strategies recommended for early stage disease diagnosis and imaging are discuessed. 
  • 500
  • 18 Jan 2023
Topic Review
Structure and Physicochemical Properties of Konjac Glucomannan
Konjac glucomannan (KGM), can not only be applied as a food additive, which greatly improves the taste and flavor of food and extends the shelf life of food but also occupies an important role in T2DM (Type 2 Diabetes Mellitus). KGM can extend gastric emptying time, increase satiety, and promote liver glycogen synthesis, and also has the potential to improve intestinal flora and the metabolic system through a variety of molecular pathways in order to positively regulate oxidative stress and immune inflammation, and protect the liver and kidneys.
  • 884
  • 01 Feb 2023
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