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
Mesenchymal Stem Cell-Derived Extracellular Vesicle and Osteoporosis
Osteoporosis, a metabolic skeletal disorder that results from the imbalance between bone formation and bone resorption, generally occurs in postmenopausal women and older people. The process of bone remodeling is participated by mainly osteoclasts and osteoblasts, together with other cells including osteocytes, bone lining cells, monocytes, chondrocytes, hematopoietic stem cells, and mesenchymal stem cells (MSCs).
  • 524
  • 14 Dec 2021
Topic Review
Medical Uses of Iron/Copper/Zinc Nanoparticles
Nanoparticles (NPs) improve delivery of ions and confer targeting capabilities, with the potential for use in treatment and diagnosis. Iron deficiency, cancer, and sepsis are persisting major issues. While targeted delivery using Fe NPs can be used as food fortifiers, chemotherapeutic agents against cancer cells and microbes have been developed using both Fe and Cu NPs. A fast and accurate means of diagnosis is a major impacting factor on outcome of patients, especially when critically ill. Good quality imaging and bed side diagnostic tools are possible using NPs, which may positively impact outcome. 
  • 606
  • 13 Dec 2021
Topic Review
Novel Approaches in the Immunotherapy of Multiple Sclerosis
Multiple Sclerosis (MS) is a serious autoimmune disease. The patient in an advanced state of the disease has restrained mobility and remains handicapped. It is therefore understandable that there is a great need for novel drugs and vaccines for the treatment of MS. 
  • 491
  • 10 Dec 2021
Topic Review
Adipose Tissue-Derived Mesenchymal Stem Cells and Cartilage Defects
Cartilage defects are a predisposing factor for osteoarthritis. Conventional therapies are mostly palliative and there is an interest in developing newer therapies that target the disease’s progression. Mesenchymal stem cells (MSCs) have been suggested as a promising therapy to restore hyaline cartilage to cartilage defects, though the optimal cell source has remained under investigation. Establishing standardised methods for MSC extraction and delivery, and performing studies with long follow-up should enable future high-quality research to provide the evidence needed to bring AMSC-based therapies into the market.
  • 485
  • 13 Dec 2021
Topic Review
Antioxidant Activity of Natural Products
Natural products identified with potential antioxidant activity need to be further evaluated in the cellular model. Antioxidant activity of a large number of natural products will not extrapolate its performance in the biological system, either in vitro as cellular assays or in vivo as animal model studies. Thus, it is necessary to examine the bioavailability, metabolism and mechanism of action in a living system to prove potential antioxidant activities of new natural products.
  • 1.4K
  • 09 Dec 2021
Topic Review
Clinical Management of Diabetic Retinopathy
Diabetic retinopathy represents a leading cause of vision loss, causing a significant structural and functional impairment of the retinal and choroidal capillary network.  Diabetes mellitus is a group of diseases characterized by chronic hyperglycemia, and the most common expressions of this condition are type 1, type 2, and gestational diabetes.
  • 593
  • 10 Dec 2021
Topic Review
4-Hydroxybutyrate Containing Polyhydroxyalkanoates Production for Biomedical Applications
Polyhydroxyalkanoates (PHA) are polyesters having high promise in biomedical applications. Among different types of PHA, poly-4-hydroxybutyrate (P4HB) is the only polymer that has received FDA approval for medical applications. However, most PHA producing microorganisms lack the ability to synthesize P4HB or PHA comprising 4-hydroxybutyrate (4HB) monomer due to their absence of a 4HB monomer supplying pathway. Thus, most microorganisms require supplementation of 4HB precursors to synthesize 4HB polymers. 
  • 1.3K
  • 09 Dec 2021
Topic Review
Hydrogels Classification
Hydrogels are attractive biomaterials with favorable characteristics due to their water uptake capacity. However, hydrogel properties are determined by the cross-linking degree and nature, the tacticity, and the crystallinity of the polymer. 
  • 1.3K
  • 08 Dec 2021
Topic Review
Current Regenerative Medicine Approaches: Three-Dimensional Culture Systems
Three-dimensional (3D) culture systems opened up new horizons in the emerging field of regenerative medicine and in studying the biology of tissues and organs, modelling various diseases, and screening drugs. Producing accurate in vitro models increases the possibilities for studying molecular control of cell–cell and cell–microenvironment interactions in detail. The Notch signalling is linked to cell fate determination, tissue definition, and maintenance in both physiological and pathological conditions. Hence, 3D cultures provide new accessible platforms for studying activation and modulation of the Notch pathway.
  • 528
  • 02 Dec 2021
Topic Review
C. Europaea Extracts
Caralluma europaea (Guss.) N.E.Br. (C. europaea), is a medicinal plant used traditionally to treat diabetes mellitus (DM) in Morocco. 
  • 394
  • 30 Nov 2021
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