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
Nanomaterials for Wound Healing and Infection Control
Wound healing has been intensely studied in order to develop an "ideal" technique that achieves expeditious recovery and reduces scarring to the minimum, thus ensuring function preservation. The classic approach to wound management is represented by topical treatments, such as antibacterial or colloidal agents, in order to prevent infection and promote a proper wound-healing process. Nanotechnology studies submicroscopic particles (maximum diameter of 100 nm), as well as correlated phenomena. Metal nanoparticles (e.g., silver, gold, zinc) are increasingly being used in dermatology, due to their beneficial effect on accelerating wound healing, as well as treating and preventing bacterial infections. Other benefits include: ease of use, less frequent dressing changes and a constantly moist wound environment. This entry highlights recent findings regarding nanoparticle application in wound management.
  • 618
  • 18 Jan 2022
Topic Review
Medicinal Cannabis—Potential Drug Interactions
The endocannabinoids system (ECS) has garnered considerable interest as a potential therapeutic target in various carcinomas and cancer-related conditions alongside neurodegenerative diseases. Cannabinoids are implemented in several physiological processes such as appetite stimulation, energy balance, pain modulation and the control of chemotherapy-induced nausea and vomiting (CINV). However, pharmacokinetics and pharmacodynamics interactions could be perceived in drug combinations, so in this short entry we tried to shed light on the potential drug interactions of medicinal cannabis. Hitherto, few data have been provided to the healthcare practitioners about the drug–drug interactions of cannabinoids with other prescription medications. In general, cannabinoids are usually well tolerated, but bidirectional effects may be expected with concomitant administered agents via affected membrane transporters (Glycoprotein p, breast cancer resistance proteins, and multidrug resistance proteins) and metabolizing enzymes (Cytochrome P450 and UDP-glucuronosyltransferases). Caution should be undertaken to closely monitor the responses of cannabis users with certain drugs to guard their safety, especially for the elderly and people with chronic diseases or kidney and liver conditions.  
  • 388
  • 17 Jan 2022
Topic Review
Melatonin/Cyclodextrin Inclusion Complexes
Melatonin (MLT) is involved in many functions of the human body, mainly in sleeping-related disorders. It also has anti-oxidant potential and has been proven very effective in the treatment of seasonal affective disorders (SAD), which afflict some people during short winter days. Melatonin has been implicated in a range of other conditions, including Parkinson’s disease, Alzheimer’s and other neurological conditions, and in certain cancers. Its poor solubility in water leads to an insufficient absorption that led scientists to investigate MLT inclusion in cyclodextrins (CDs), as inclusion of drugs in CDs is a way of increasing the solubility of many lipophilic moieties with poor water solubility. 
  • 593
  • 17 Jan 2022
Topic Review
Novel Excipients Used in Modified Release Vaginal Formulations
The formulation of an ideal vaginal drug delivery system (DDS), with the requisite properties, with respect to safety, efficacy, patient compliance, aesthetics, harmonization with the regulatory requirements, and cost, requires a meticulous selection of the active ingredients and the excipients used. Novel excipients defined by diversity and multifunctionality are used in order to ameliorate drug delivery attributes. Synthetic and natural polymers are broadly used in pharmaceutical vaginal formulations (solid, semi-solid dosage forms, implantable devices, and nanomedicines) with a promising perspective in improving stability and compatibility issues when administered topically or systemically. Moreover, the use of biopolymers is aiming towards formulating novel bioactive, biocompatible, and biodegradable DDSs with a controllable drug release rate. 
  • 1.4K
  • 14 Jan 2022
Topic Review
Inorganic SOD1 Inhibitors with Anti-Cancer Prospects
For eukaryotic cells, reactive oxygen species (ROS) encompass a group of molecules derived from oxygen. Due to the well-established role of ROS in cell signaling, cancer cells always have higher levels of endogenous ROS to enhance rapid cell growth and proliferation through the mitogen-activated protein kinase (MAPK)/extracellular-regulated kinase 1/2 (ERK1/2), phosphoinositide-3-kinase (PI3K)/Akt, nuclear factor-κB (NF-κB), and hypoxia-sensitive α (HIF1α) pathways. Evaluated ROS have frequently been observed in various cancers, which activate multiple pro-tumourigenic signaling, and induce survival and proliferation of cancer cells. Hydrogen peroxide and superoxide anion are the most important redox signaling agents in cancer cells, whose homeostasis is maintained by dozens of growth factors, cytokines and antioxidant enzymes. Therefore, antioxidant enzymes, especially Cu/Zn superoxide dismutase (SOD1), tend to have higher activities to maintain the homeostasis of ROS in cancer cells. We can inhibit the activity of SOD1 using copper chelators to kill cancer cells. 
  • 394
  • 13 Jan 2022
Topic Review
Lactiplantibacillus (Lpb.) plantarum
Lactic acid fermentation of fresh fruit juices is a low-cost and sustainable process, that aims to preserve and even enhance the organoleptic and nutritional features of the raw matrices and extend their shelf life. Selected Lactic Acid Bacteria (LAB) were evaluated in the fermentation of various fruit juices, leading in some cases to fruit beverages, with enhanced nutritional and sensorial characteristics. Among LAB, Lactiplantibacillus (Lpb.) plantarum subsp. plantarum strains are quite interesting, regarding their application in the fermentation of a broad range of plant-derived substrates, such as vegetables and fruit juices, since they have genome plasticity and high versatility and flexibility. L. plantarum exhibits a remarkable portfolio of enzymes that make it very important and multi-functional in fruit juice fermentations. Therefore, L. plantarum has the potential for the production of various bioactive compounds, which enhance the nutritional value and the shelf life of the final product. In addition, L. plantarum can positively modify the flavor of fruit juices, leading to higher content of desirable volatile compounds.
  • 784
  • 11 Jan 2022
Topic Review
Antibiotics and Their Impact on Bacterial Cellular Perturbation
Antibiotics belong to different classes of chemicals—including those of biological, synthetic, or semi-synthetic origin—and have selective modes of action. Based on their mechanisms of action, antimicrobial compounds are classified into two groups: bacteriostatic and bactericidal. Resistance is a natural adaptive tool that offers selection pressure to bacteria, and hence cannot be stopped entirely but rather be slowed down. Antibiotic resistance mutations mostly diminish bacterial reproductive fitness in an environment without antibiotics; however, a fraction of resistant populations ‘accidentally’ emerge as the fittest and thrive in a specific environmental condition, thus favouring the origin of a successful resistant clone.
  • 613
  • 11 Jan 2022
Topic Review
Wearable Sensors for Wound Infection Biomarkers Detection
Infection represents a major complication that can affect wound healing in any type of wound, especially in chronic ones. There are currently certain limitations to the methods that are used for establishing a clinical diagnosis of wound infection. Thus, new, rapid and easy-to-use strategies for wound infection diagnosis need to be developed. To this aim, wearable sensors for infection diagnosis have been recently developed. These sensors are incorporated into the wound dressings that are used to treat and protect the wound, and are able to detect certain biomarkers that can be correlated with the presence of wound infection. Among these biomarkers, the most commonly used ones are pH and uric acid, but a plethora of others (lactic acid, oxygenation, inflammatory mediators, bacteria metabolites or bacteria) have also been detected using wearable sensors.
  • 507
  • 10 Jan 2022
Topic Review
Natural Polymers Used in Edible Food Packaging
Natural polymers like polysaccharides and proteins, i.e., alginate; carrageenan; chitosan; starch; pea protein, are important materials obtained from renewable plant, algae and animal sources, as well as from agroindustrial residues. Historically, some of them have been widely used by ancient populations for food packaging until these were replaced by petroleum-based plastic materials after World War II. Nowadays, biobased materials for food packaging have attracted attention. Their use was boosted especially because of the environmental pollution caused by inappropriate disposal of plastic packaging. Biobased materials are welcome to the design of food packaging because they possess many advantages, such as biodegradability, biocompatibility and low toxicity. Depending on the formulation, certain biopolymer-based packaging may present good barrier properties, antimicrobial and antioxidant activities Thus, polysaccharides and proteins can be combined to form diverse composite films with improved mechanical and biological behaviors, making them suitable for packaging of different food products. 
  • 2.9K
  • 10 Jan 2022
Topic Review
3D-Bioprinting for Chronic Wound
Skin substitutes can provide a temporary or permanent treatment option for chronic wounds. The selection of skin substitutes depends on several factors, including the type of wound and its severity. Full-thickness skin grafts (SGs) require a well-vascularised bed and sometimes will lead to contraction and scarring formation. Besides, donor sites for full-thickness skin grafts are very limited if the wound area is big, and it has been proven to have the lowest survival rate compared to thick- and thin-split thickness. Tissue engineering technology has introduced new advanced strategies since the last decades to fabricate the composite scaffold via the 3D-bioprinting approach as a tissue replacement strategy. Considering the current global donor shortage for autologous split-thickness skin graft (ASSG), skin 3D-bioprinting has emerged as a potential alternative to replace the ASSG treatment. The three-dimensional (3D)-bioprinting technique yields scaffold fabrication with the combination of biomaterials and cells to form bioinks. 
  • 1.5K
  • 08 Jan 2022
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