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
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.
  • 863
  • 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.
  • 311
  • 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. 
  • 421
  • 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.
  • 428
  • 26 Jun 2023
Topic Review
Plant-Based CTB-INS Oral Vaccines
Oral delivery of tissue-specific autoantigens may be helpful for the clinical prevention of spontaneous autoimmune diabetes. However, the therapeutic potential has been restricted by the need for recurrent delivery of large amounts of autoantigen, and tolerance is often less successful in already sensitized hosts. These limitations were overcome by transporting chemically conjugated autoantigens for the induction of oral tolerance utilizing the nontoxic B subunit of cholera toxin (CTB).  
  • 351
  • 18 Jul 2023
Topic Review
Healthy Benefits of Hylocereus Species
The dragon fruit of pitaya is a rustic fruit belonging to the Cactaceae family, the genus Hylocereus. It is known as dragon fruit due to the presence of bright red skin with overlapping green fins covering the fruit. Other common names given to this fruit are pitahaya, dragon pearl fruit, night-blooming cereus, strawberry pear, and Cinderella plant. Depending on the species, its fruits may have different characteristics, such as shape, presence of thorns, skin, and pulp color, reflecting high genetic variability. The health-promoting potential of pitaya fruit is due to the presence of bioactive compounds related to numerous benefits such as anti-diabetic, anti-inflammatory, antioxidant, anti-cancer, and antimicrobial. As a result of these beneficial actions, the consumption of this fruit has increased in different regions worldwide.
  • 468
  • 13 Jun 2023
Topic Review
Properties and Biomedical Application of Chitosan-Based Hydrogels
The prospective applications of chitosan-based hydrogels (CBHs), a category of biocompatible and biodegradable materials, in biomedical disciplines such as tissue engineering, wound healing, drug delivery, and biosensing have garnered great interest. The synthesis and characterization processes used to create CBHs play a significant role in determining their characteristics and effectiveness. 
  • 705
  • 13 Jun 2023
Topic Review
Applications of Asymmetric Lipid Vesicles
Liposomes have been widely studied for drug release applications, for which they are known to have the desired effect by releasing specific concentrations on site. In drug delivery, when a drug is supplied directly to the bloodstream, problems such as short circulation times, drug breakdown, and clearance are lessened. Liposomes are an alternative to avoid these problems because they can trap the drug, control the dosage need, and have an effective drug concentration to target the desired cells.
  • 269
  • 09 Jun 2023
Topic Review
Applications of Humanized Mice in Oncology
While chemotherapies remain the mainstay treatments for many cancers, the advent of new molecular techniques has opened doors for more targeted modalities towards cancer cells. Although immune checkpoint inhibitors (ICIs) have demonstrated therapeutic efficacy in treating cancer, adverse side effects related to excessive inflammation are often reported. There is a lack of clinically relevant animal models to probe the human immune response towards ICI-based interventions. Humanized mouse models have emerged as valuable tools for pre-clinical research to evaluate the efficacy and safety of immunotherapy. 
  • 489
  • 05 Jun 2023
Topic Review
Principles of pH-Responsive Drug Delivery
The paradigm of drug carriers’ usage to overcome the non-specific distribution of therapeutic agents in the body, including chemotherapeutic substances that exert severe toxic stress on healthy tissues, has been actively developed. One of the main pillars of this paradigm is the increased or even selective accumulation of drug delivery systems (DDSs) carrying therapeutic agents in tumor interstitium harnessing the differences between normal and cancer tissues properties. Thus, structural features of tumors, such as hypervascularization, vascular pathologies, and impaired functionality of lymphatic drainage, can be utilized to differentiate tumors from healthy tissues and selectively accumulate drug carriers. In particular, tumor-surrounding vessels are characterized by defects in the endothelial layer lining the blood vessel wall, represented by wide fenestrations (up to several microns) and other features that lead to an increase in the permeability of this barrier for small objects, making the effective extravasation of nanosized carriers from the bloodstream to tumor interstitium possible. Methods of selective therapy via the systemic administration of therapeutic agents based on increased permeability of the tumor vessels’ wall, known under the general name of the EPR effect, have become widespread and have inspired the creation of a large number of vehicles proposed for the delivery of chemotherapeutic agents. In summary, the EPR effect implies the extravasation of nanosized drug carriers through endothelial fenestra and their retention in the interstitial volume of the tumor due to dysfunctional lymphatic drainage.
  • 410
  • 01 Jun 2023
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