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
Pharmacology of Lactoferrin Formulations
Lactoferrin is an 80 kDa monomeric glycoprotein that exhibits multitask activities of interest in the pharmaceutical field for the design of products with therapeutic potential including nanoparticles, liposomes, among many others. Lactoferrin has been included in delivery systems to transport and protect drugs from enzymatic degradation in the intestine favoring the bioavailability for the treatment of inflammatory bowel disease and colon cancer. Moreover, nanoparticles loaded with lactoferrin have been formulated as delivery system to transport drugs for neurodegenerative diseases, which cannot cross the blood-brain barrier to enter toward the central nervous system. Pharmaceutical products containing lactoferrin as either bioactive or on those products formulated with lactoferrin as carrier have been designed considering their interaction with receptors expressed in tissues as targets of drugs delivered via parenteral or mucosal administration. These lactoferrin preparations may be sustainable approaches that may contributed decreasing resistance of antimicrobials and enhancing the bioavailability of first-hand drugs for intestinal chronic inflammation and neurodegenerative diseases.
  • 1.3K
  • 13 Feb 2023
Topic Review
Vaccines against Antibiotic Resistance
Despite the great efforts made by researchers and companies to develop new antimicrobial drugs, only a few molecules have been recognized so far as effective antibiotic candidates. In fact, the number of new antimicrobials developed later than the 90s has progressively diminished, and many of them correspond to slight modifications of existing drugs. Apart from the difficulties in developing new effective antimicrobials, the worrying scenario of the antimicrobial resistance (AMR) recalls the urgent need of new strategies to fight the bacterial infections. Among the others, vaccination is a winning solution to the problem of the  AMR, at least in the context of some of the most common pathogenic bacteria.
  • 1.0K
  • 14 Feb 2023
Topic Review
Recently Used Drug Targets and Autophagy
Autophagy is a governed catabolic framework enabling the recycling of nutrients from injured organelles and other cellular constituents via a lysosomal breakdown. This mechanism has been associated with the development of various pathologic conditions, including cancer and neurological disorders; however, recently updated studies have indicated that autophagy plays a dual role in cancer, acting as a cytoprotective or cytotoxic mechanism. It has recently been found that autophagy regulation is an intriguing and potentially useful strategy to improve cancer treatments. Numerous studies have indicated autophagy’s dual roles for several drugs that might be modulated to suppress or promote tumor growth, and the following sections describe autophagy’s dual function in recent drug treatments.
  • 1.4K
  • 10 Feb 2023
Topic Review
Targeted Therapy for NSCLC Patients with EGFR Mutations
Oncogenic mutations within the epidermal growth factor receptor (EGFR) kinase domain are well-established driver mutations in non–small cell lung cancer (NSCLC). Small-molecule tyrosine kinase inhibitors (TKIs) specifically targeting these mutations have improved treatment outcomes for patients with this subtype of NSCLC. Multiple targeted agents, including first-, second- and third-generation EGFR TKIs, have been approved or are under active investigation for patients with EGFR-mutant NSCLC. The first-generation TKIs, including erlotinib and gefitinib, are reversible inhibitors, binding both to mutant as well as wild-type (WT) EGFR. The second-generation TKIs, including afatinib and dacomitinib, are irreversible inhibitors that covalently bind to EGFR. The third-generation EGFR TKIs, including osimertinib (AZD9291), aumolertinib (HS-10296) and alflutinib (AST2818), are irreversible inhibitors that selectively bind to mutant EGFR and show greater efficacy than the first- and second-generation TKIs. Osimertinib has been approved by the FDA for both frontline and second-line treatment of NSCLC with EGFR-sensitizing mutations. Aumolertinib (HS-10296) and alflutinib (AST2818) have been approved for the treatment of EGFR-mutant NSCLC in China. Acquired resistance inevitably occurs, and a promising new generation of EGFR-targeting agents is under investigation.
  • 4.7K
  • 09 Feb 2023
Topic Review
Phytochemical Information and Pharmacology of European Orchids
The Orchidaceae family has thousands of members, and most of them are mentioned in the folk medicine of nations around the world. The use of terrestrial orchids in European and Mediterranean regions has been reported since ancient times. Plant collection for human use is still listed as one of the main threats for terrestrial orchids (i.e. harvesting for Salep), alongside other menacing factors such as wrong habitat management and disturbance to symbionts, such as pollinators and mycorrhizal fungi. Here, phytochemical data are discussed to evaluate the presence of bioactive compounds of pharmacological relevance. Furthermore, it is debated whether the presence of these compounds could support the therapeutic employment of the different orchid organs.
  • 1.9K
  • 09 Feb 2023
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.
  • 2.5K
  • 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. 
  • 2.3K
  • 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. 
  • 1.3K
  • 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.
  • 1.0K
  • 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. 
  • 1.2K
  • 03 Feb 2023
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