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
Antibodies and T Cells in Viral Infections
The vertebrate immune system functions to eliminate foreign nucleic acids that invade from infectious pathogens and malignant tumors. DNA/RNA motifs characteristic to microbes and cancer cells are recognized as "non-self" by the host innate immune system, represented by pattern-recognition receptors (PRRs), thereby being classified into microbe-associated molecular patterns (MAMPs). MAMPs participate in immune enhancement, which is a host strategy to eliminate invading cells. That is, a variety of PRRs recognize nucleic acid MAMPs. Of the Toll-like receptors (TLRs), TLR3 recognizes RNA double-stranded (ds) motifs such as viral dsRNA. TLR3 is particular in that 1. It is preferentially expressed in endosomes of antigen-presenting dendritic cells (CD141+ DCs), 2. It can be an exclusive target to induce cross-antigen presentation, 3. Several structured RNAs successfully attain endosomal TLR3 in antigen-presenting (CD141+) DCs. Here the researchers summarize the current status of TLR3 adjuvants designed to enter cells without transfection, minimize inflammatory side effects, and provide optimal immune enhancement.
  • 675
  • 09 Jan 2023
Topic Review
Tumor-Associated Macrophages in Targeting Solid Cancers
Macrophages are effector cells of the innate immune system, which can play a crucial role in the generation of anti-tumor immunity through their ability to phagocytose cancer cells and present tumor antigens to the cells of adaptive immunity. However, the macrophages that are recruited to the tumor microenvironment predominantly play pro-tumorigenic roles. Several strategies targeting pro-tumorigenic functions and harnessing the anti-tumorigenic properties of macrophages have shown promising results in preclinical studies, and a few of them have also advanced to clinical trials. 
  • 1.2K
  • 06 Jan 2023
Topic Review
Antimicrobial Nanomaterials Based on Halloysite Clay Mineral
Bacterial infections represent one of the major causes of mortality worldwide. Over the years, several nanomaterials with antibacterial properties have been developed. In this context, clay minerals, because of their intrinsic properties, have been efficiently used as antimicrobial agents since ancient times. Halloysite nanotubes are one of the emerging nanomaterials that have found application as antimicrobial agents in several fields. 
  • 421
  • 08 Jan 2023
Topic Review
Drug-Induced Liver Damage and microRNAs
The liver plays a central role in transforming macronutrients and clearance of chemicals and drugs. The serum biomarkers often used to indicate liver damage are not specifically for drug-induced liver injury (DILI) or liver injury caused by other xenobiotics, nor for viral infection. In this case, microRNAs (miRNAs) could play an exciting role as biomarkers of specific liver damage. The evidence that circulating miR-122 could be used as a human biomarker of DILI came from several studies in which a substantial increase of it was linked with liver function status.
  • 330
  • 06 Jan 2023
Topic Review
Developments in FRET- and BRET-Based Biosensors
Resonance energy transfer technologies have achieved great success in the field of analysis. Particularly, fluorescence resonance energy transfer (FRET) and bioluminescence resonance energy transfer (BRET) provide strategies to design tools for sensing molecules and monitoring biological processes, which promote the development of biosensors.
  • 571
  • 06 Jan 2023
Topic Review
4D Printing Technology
4D printing (4DP) is an evolution of 3DP where additive manufacturing printing techniques are employed. In other words, adapting 3DP processes for 4DP of shape memory polymers (SMPs) or smart materials requires minor adjustments. In order to produce the desired shape-changing materials as per estimation or for optimal application, an air circulation system may be incorporated into 3DP’s traditional fused deposition method (FDM) technology. This would cool the SMP below its Tg and, after these small alterations, previous 3DP methods such as stereolithography apparatus (SLA), digital laser writing and inkjet printing can also be employed.
  • 447
  • 05 Jan 2023
Topic Review
The Role of Pulmonary Surfactant Phospholipids in Interstitial Lung Diseases
Diffuse parenchymal lung diseases (DPLD) or Interstitial lung diseases (ILD) are a heterogeneous group of lung conditions with common characteristics that can progress to fibrosis. Within this group of pneumonias, idiopathic pulmonary fibrosis (IPF) is considered the most common. This disease has no known cause, is devastating and has no cure.
  • 593
  • 04 Jan 2023
Topic Review
Liposomal Amphotericin B for Treatment of Leishmaniasis
The liposomal amphotericin B (AmB) formulation, AmBisome®, still represents the best therapeutic option for cutaneous and visceral leishmaniasis. However, the need for parenteral administration, its side effects and high cost significantly limit its use in developing countries. The recent advances in the development of topical and oral formulations of liposomal AmB are presented, in addition to the current knowledge on the physicochemical and pharmacological features of AmB.
  • 538
  • 24 Jan 2023
Topic Review
Active Ingredients and Medicinal Properties of Medicinal Mushrooms
Fruiting bodies, mycelia, or spores in the form of extracts or powder of various medicinal mushrooms are used to prevent, treat, or cure a range of ailments and balance a healthy diet. Medicinal mushrooms are found in several genera of fungi and their fruit bodies, cultured mycelia, and cultured broth contains phytochemical constituents such as triterpenes, lectins, steroids, phenols, polyphenols, lactones, statins, alkaloids, and antibiotics. Edible mushrooms are considered functional foods that can be used as supplements for complementary and alternative medicines where the markets are growing rapidly. Several species of edible mushrooms possess therapeutic potential and functional characteristics. The psilocybin-containing types, sometimes known as magic mushrooms, have been utilized for generations by indigenous communities due to their hallucinogenic, medicinal, and mind-manifestation properties.
  • 809
  • 03 Jan 2023
Topic Review
Treating Delusional Disorder with Antipsychotics
Delusional disorder (DD) has been considered a treatment-resistant disorder, with antipsychotics acknowledged as the best. It is possible that the discovery of the right drug could turn treatment resistance into treatment response.
  • 1.2K
  • 29 Dec 2022
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