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
Noncoding-RNA-Based Therapeutics
Noncoding RNAs (ncRNAs) defy the central dogma by representing a family of RNA molecules that are not translated into protein but can convey information encoded in their DNA.  The importance of understanding ncRNA is apparent since these molecules regulate gene expression at the transcriptional and post-transcriptional level exerting pleiotropic effects critical in development, oncogenesis, and immunity. Multiple therapeutic modalities are available for advanced Prostatic Carcinoma (PC), include hormone therapy, chemotherapy, immunotherapy, radiation and salvage prostatectomy, or various combinations of the aforementioned strategies. Despite significant therapeutic progress, metastatic PC  remains incurable, and therefore, new treatments, including ncRNA therapeutics (which may be used alone or in combination with current options) are necessary. 
  • 524
  • 23 Feb 2022
Topic Review
Molluscivorous and Vermivorous Conus Species
It is generally believed that more than 700 Conus species have evolved during the last 50 million years. With the highest species abundance occurring in southeast Asia, most Conus can be found in the shallow waters of tropical and subtropical oceans. Conus is widely distributed in rocky shores, sandy beaches, coral reefs and intertidal waters, with depths reaching up to over 600 m. Nowadays, Conus species are generally overexploited, and some species are now endangered. Exploring these waters of potentially high species diversity could enrich our understanding of their population’s genetic structure and provide the missing pieces for clarifying Conus evolution. As the conotoxin compounds vary greatly throughout the growth stages and across geolocations within the same species, further investigation of these species-specific regional distribution differences may provide crucial insights for artificial breeding and harvesting specific bioactive compounds in the future.
  • 815
  • 18 Feb 2022
Topic Review
Bone Marrow Aspirate Concentrate
Human bone marrow (BM) has been highlighted as a promising source of mesenchymal stromal cells (MSCs) containing various growth factors and cytokines that can be potentially utilized in regenerative procedures involving cartilage and bone.
  • 607
  • 15 Feb 2022
Topic Review
Endophytic Fungi Biosynthesize Important Therapeutic Drugs
In general, microbes produce a collection of secondary metabolites with therapeutic activities. Many are used as anticancer, immunosuppressive, hypocholesterolemic, antiparasitic, anti-inflammatory agents, or as enzyme inhibitors. Indeed, endophytic fungi have become a treasure trove for bioactive compounds of medicinal and agricultural importance. Several endophytic fungi produce important therapeutic drugs, initially discovered in traditional medicinal plants; for example, paclitaxel, podophyllotoxin, Vinca alkaloids, camptothecin, and fusidic acid.
  • 578
  • 11 Feb 2022
Topic Review
Laccases
Laccase (p-diphenol, EC1.10.3.2) is a copper-containing glycoprotein oxidase. Plant laccase is a ubiquitous multifunctional protein that encodes a large gene family. 
  • 484
  • 07 Feb 2022
Topic Review
Receptor-Mediated Targeted Delivery of Surface-ModifiedNanomedicine in Breast Cancer
Breast cancer therapeutic intervention continues to be ambiguous owing to the lack of strategies for targeted transport and receptor-mediated uptake of drugs by cancer cells. In addition to this, sporadic tumor microenvironment, prominent restrictions with conventional chemotherapy, and multidrug-resistant mechanisms of breast cancer cells possess a big challenge to even otherwise optimal and efficacious breast cancer treatment strategies. Surface-modified nanomedicines can expedite the cellular uptake and delivery of drug-loaded nanoparticulate constructs through binding with specific receptors overexpressed aberrantly on the tumor cell.
  • 549
  • 07 Feb 2022
Topic Review
Nanomedicine and Brain Tumors
A brain tumor, a tumor that develops within the skull, is an abnormal mass of tissue in which cells grow and multiply out of control. Although more than 150 types of brain tumors have been reported, they are macroscopically divided into primary and metastatic groups. Tumors that arise directly from the brain tissue or surrounding the brain are classified as primary brain tumors.
  • 518
  • 27 Jan 2022
Topic Review
Structure-Based Approach in Drug Design
Structure-based drug design (SBDD) is the computational approach that relies on knowledge of 3D structures of the biological targets to identify or design the potential chemical structure suitable for clinical tests. With the explosion of genomic, functional, and structural information in recent decades, the majority of biological targets with 3D structure have been identified and stimulated the applications of structure-based approaches in the current design pipeline. SBDD is popular for virtual screening to filter the drug-like compounds from a large library of small molecules, including widely applied approaches, such as docking and structure-based pharmacophore design. 
  • 3.9K
  • 24 Jan 2022
Topic Review
Ribosome Display Technology
Antibody ribosome display remains one of the most successful in vitro selection technologies for antibodies fifteen years after it was developed. The unique possibility of direct generation of whole proteins, particularly single-chain antibody fragments (scFvs), has facilitated the establishment of this technology as one of the foremost antibody production methods. Ribosome display has become a vital tool for efficient and low-cost production of antibodies for diagnostics due to its advantageous ability to screen large libraries and generate binders of high affinity. The remarkable flexibility of this method enables its applicability to various platforms. 
  • 629
  • 11 Mar 2022
Topic Review
Nanostructured Lipid Carriers-Hydrogels System for Drug Delivery
Nanostructured lipid carriers (NLC) are lipid nanoparticles of the second generation made up of solid lipid matrices mixed with liquid lipids (oils). The hybrid system between NLC and hydrogel may results in the enhancement of each component's synergistic properties in the mechanical strength of the hydrogel and concomitantly decrease aggregation of the NLC. Therefore, the advanced hybrid component development in nanotechnology provides superior functionality in the application of scientific knowledge for the drug delivery industry. 
  • 700
  • 25 Jan 2022
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