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
Biological Barriers to Oral Drug Delivery Systems
The oral route is the most preferred route for systemic and local drug delivery. However, the oral drug delivery system faces the harsh physiological and physicochemical environment of the gastrointestinal tract, which limits the bioavailability and targeted design of oral drug delivery system.
  • 1.1K
  • 08 Feb 2023
Topic Review
Cyclin-Dependent Kinase 4/6 Inhibitors in the Tumor Microenvironment
Cancer is characterized by persistent cell proliferation driven by aberrant cell cycle regulation and stimulation of cyclin-dependent kinases (CDKs). A very intriguing and potential approach for the development of antitumor medicines is the suppression of CDKs that lead to induction of apoptosis and cell cycle arrest. The shift of the cell cycle from the G0/G1 phase to the S phase, which is characterized by active transcription and synthesis, depends on the development of the cyclin D-CDK4/6 complex. A precise balance between anticancer activity and general toxicity is demonstrated by CDK inhibitors, which can specifically block CDK4/6 and control the cell cycle by reducing the G1 to S phase transition. 
  • 595
  • 08 Feb 2023
Topic Review
Functional Food Ingredients for Viral Diseases
A complex network of processes within the human immune system provides resistance to a variety of disease states. This defense forms innate and adaptive immunity, with specific immune components working together to combat infection. In addition to genetic variables, susceptibility to disease can be influenced by factors such as lifestyle, age and environmental factors. Certain food chemicals have been shown to modulate signaling and cell morphology. This has implications for pathophysiology. Eating some functional foods can increase the activity of immune cells and protect us from various diseases, including those caused by viruses as discussed below. 
  • 648
  • 07 Feb 2023
Topic Review
Omega-3 PUFAs and OvCa
Different strategies have been investigated for a more satisfactory treatment of advanced breast cancer, including the adjuvant use of omega-3 polyunsaturated fatty acids (PUFAs). These nutritional compounds have been shown to possess potent anti-inflammatory and antiangiogenic activities, the capacity to affect transduction pathways/receptors involved in cell growth and to reprogram tumor microenvironment. Omega-3 PUFA-containing nanoformulations designed for drug delivery in breast cancer were shown to potentiate the effects of enclosed drugs, enhance drug delivery to target sites, and minimize drug-induced side effects.
  • 469
  • 03 Feb 2023
Topic Review
Therapeutic of Valproic Acid Metabolites ant Its Role
Valproic acid (CH3CH2CH2)2CHCOOH 2-propylvaleric acid, VPA) is a fatty acid derivative originally synthesized. Valproic acid (VPA) and its salts are psychotropic drugs that are widely used in neurological diseases (epilepsy, neuropathic pain, migraine, etc.) and psychiatric disorders (schizophrenia, bipolar affective disorder, addiction diseases, etc.). In addition, the indications for the appointment of valproate have been expanding in recent years in connection with the study of new mechanisms of action of therapeutic and toxic metabolites of VPA in the human body. Thus, VPA is considered a component of disease-modifying therapy for multiple tumors, neurodegenerative diseases (Huntington’s disease, Parkinson’s disease, Duchenne progressive dystrophy, etc.), and human immunodeficiency syndrome. The metabolism of VPA is complex and continues to be studied. Known pathways of VPA metabolism include: β-oxidation in the tricarboxylic acid cycle (acetylation); oxidation with the participation of cytochrome P-450 isoenzymes (P-oxidation); and glucuronidation. The complex metabolism of VPA explains the diversity of its active and inactive metabolites, which have therapeutic, neutral, or toxic effects. 
  • 563
  • 03 Feb 2023
Topic Review
Production and Recovery of Ectoine
Ectoine (CAS No.: 96702-03-3), chemically known as 1,4,5,6-tetrahydro-2-methyl-4-pyrimidinecarboxylic acid, is a heterocyclic amino acid derivative of aspartate with a zwitterionic structure. Ectoine was first identified and isolated from a halophilic bacterium, Ectothiorhodospira halochloris.
  • 680
  • 02 Feb 2023
Topic Review
Advanced Drug Delivery for Treating Sjögren’s Dry Eye
Sjögren’s syndrome is a chronic and insidious autoimmune disease characterized by lymphocyte infiltration of exocrine glands. Patients typically present with dry eye (keratoconjunctivitis sicca), dry mouth (xerostomia), and other systemic manifestations. The current management for Sjögren's syndrome dry eye (SSDE) has been ineffective as it only targets ocular surface inflammation and dryness without addressing the specific disease process. Ophthalmologists often adopt a trial-and-error approach, which allows the cycle of dry eye disease (DED) to progress and potentially cause permanent damage to the lacrimal functional unit. Topical treatments also depend on patients' ability to administer eye drops and their compliance. These limitations emphasize the need for personalized, targeted treatments that address the underlying pathophysiology of SSDE. This article aims to present new advances in ocular drug delivery for more effective treatment.
  • 536
  • 10 Feb 2023
Topic Review
Hsp90α and Hsp90β
Hsp90α and Hsp90β are both ubiquitously expressed in all cell types, but assigned for distinct and irreplaceable functions. Hsp90β is essential during mouse development and Hsp90α only maintains male reproductivity in adult mice. Neither Hsp90β nor Hsp90α could substitute each other under these biological processes. Hsp90β alone maintains cell survival in culture and Hsp90α cannot substitute it. Hsp90α also has extracellular functions under stress and Hsp90β does not.
  • 392
  • 02 Feb 2023
Topic Review
Plant-Based Compounds Against SARS-CoV-2
Polyphenols and alkaloids are the most widespread plant-based products with prominent properties including anti-cancer, antioxidant, antimalarial, antiviral, antibacterial, antifungal, anti-diabetic, anti-inflammatory, and anti-dengue effects. Accordingly, these phytochemicals can be promising candidates for discovering effective therapeutic regimens for SARS-CoV-2. 
  • 515
  • 02 Feb 2023
Topic Review
Serratiopeptidase
Microbial products have been used for the treatment of different diseases for many centuries. The serratiopeptidase enzyme provides a new hope for COVID-19-infected patients. Anti-inflammatory drugs are easy to obtain at minimal expenditure from microbial sources. Serratia sp. is identified as one of the most efficient bacteria produced from serratiopeptidase. Screening for new and efficient bacterial strains from different sources has been of interest. Serratiopeptidase remains the most well-known anti-inflammatory drug of choice. Serratiopeptidase is a cheaper and safer anti-inflammatory drug alternative to NSAIDs.
  • 1.9K
  • 01 Feb 2023
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