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
Somatic Cell Therapy Medicinal Products Treat Retinal Dystrophies
Inherited retinal dystrophies and retinal degenerations related to more common diseases (i.e., age-related macular dystrophy) are a major issue and one of the main causes of low vision in pediatric and elderly age groups. Advancement and understanding in molecular biology and the possibilities raised by gene-editing techniques opened a new era for clinicians and patients due to feasible possibilities of treating disabling diseases and the reduction in their complications burden.
  • 765
  • 24 Jun 2022
Topic Review
Anthracycline Dutomycin
Anthracycline dutomycin is a tetracyclic quinone glycoside produced by Streptomyces minoensis NRRL B-5482. SW91 is a C-12 demethylated dutomycin derivative. In vitro cytotoxicity and apoptosis assays of these two compounds were conducted to demonstrate their antiproliferation activities.
  • 939
  • 24 Jun 2022
Topic Review
Bispecific Antibodies in Cancer Immunotherapy
Immunotherapy has redefined the treatment of cancer patients and it is constantly generating new advances and approaches. Among the multiple options of immunotherapy, bispecific antibodies (bsAbs) represent a novel thoughtful approach. These drugs integrate the action of the immune system in a strategy to redirect the activation of innate and adaptive immunity toward specific antigens and specific tumor locations.
  • 2.9K
  • 22 Jun 2022
Topic Review
Fts-Z Inhibition
Fts-Z is being explored as potent target for inhibiting emerging microbes due to its central role in Z-ring formation and conserved nature in nearly all bacterial species and absence in higher eukaryotes. Its absence in bacteria induces filamentation and cell death occurs. Antimicrobial resistance (AMR) is a pressing issue worldwide that must be addressed swiftly. It is driven by spontaneous evolution, bacterial mutation, and the dissemination of resistant genes via horizontal gene transfer. Researchers are working on many novel targets, which can become a pathway to inhibit harmful bacteria. Filamentous Thermosensitive mutant-Z (Fts-Z) is one such bacterial target that has gained popularity amongst scientists due to its conserved nature in bacteria and absence in eukaryotes.
  • 1.1K
  • 22 Jun 2022
Topic Review
Systemic Antibiotic Prophylaxis in Maxillofacial Trauma
Infection after maxillofacial trauma remains an important complication, with a significant socio-economic impact. While consensus exists that systemic antibiotic prophylaxis reduces the risk of infection in the management of maxillofacial fractures, the type, and duration remain controversial. 
  • 896
  • 22 Jun 2022
Topic Review
99mTc-Aprotinin in Diagnosis of Cardiac Amyloidosis
Aprotinin is a serine protease inhibitor. Several studies investigated the use of 99mTc-labelled Aprotinin as an amyloid seeker. In vitro tests showed high binding affinity for several types of amyloid fibrils accompanied by an excellent specificity. Initial human studies demonstrated good accuracy in detecting cardiac involvement. Scintigraphy results were confirmed in a group of 28 endomyocardial biopsies. Unfortunately, clinical studies were halted because of a temporary suspension of the vector protein (Trasylol) and public health concerns over prion contamination of the bovine origin compound. To obviate these limitations, efforts have been made to label a recombinant Aprotinin with 99mTc, which exhibits the same affinity for h-insulin fibrils.
  • 663
  • 20 Jun 2022
Topic Review
Natural and Semi-Synthetic Compounds for Wound Healing
Skin wounds are injuries that compromise or damage the structural integrity and optimal functioning of the skin and can be grouped into acute and chronic depending on the skin repair and recovery time frame. Specific interest is given to Aloevera, curcumin, cinnamaldehyde, polyhexanide, retinoids, ascorbate, tocochromanols, and chitosan. These compounds (when alone or in formulation with other biologically active molecules) could be a dependable alternative in the management or prevention of chronic wounds.
  • 1.5K
  • 27 Jun 2022
Topic Review
Proteasome Allostery
Allostery fundamentally describes coordination and communication between distinct sites of a multipart and multifunctional protein, or riboprotein. The proteasome rivals the ribosome in size, compositional complexity, multiplicity of active sites and substrate interactions and its importance in the cellular economy. For both, the cellular consequences of its misregulation are grave. Like the ribosome, proteasomes must coordinate multiple active sites and undergo large scale conformational realignments that optimally position its components for enzymatic processing and to move substrates. The expectation that proteasomes utilize allostery is supported by two types of experimental data. The first consists of regulators that are substrates or their components. The second consists of RPs that exhibit cooperative binding to the pair of CP sites where they dock.
  • 704
  • 14 Jun 2022
Topic Review
Eckols: Potential Cancer Therapies
In recent years, an increased interest in marine macroalgae bioactive compounds has been recorded due to their benefits to human health and welfare. Several of their bioactivities have been demonstrated, such as anti-inflammatory, antioxidant, anticarcinogenic, antibacterial and antiviral behavior.However, there is still lacking a clear definition to how these compounds exert their bioactive properties. Of all bioactive compounds from marine macroalgae, attention has been focused on phenolic compounds, specifically in phlorotannins, due to their potential for biomedical applications. Phlorotannins are a diverse and wide group of phenolic compounds, with several structural variations with base in the monomer phloroglucinol. Of all the diverse phlorotannins structures, eckol-family of phlorotannins demonstrates remarkable bioactivity, especially regarding anti-tumoral properties.
  • 1.0K
  • 13 Jun 2022
Topic Review
Circulating microRNAs in Medicine
Circulating microRNAs (c-microRNAs, c-miRNAs), which are in almost all biological fluids, are promising sensitive biomarkers for various diseases (oncological and cardiovascular diseases, neurodegenerative pathologies, etc.), and their signatures accurately reflect the state of the body. The discovery of microRNAs was a scientific breakthrough, and the study of their functional potential opened up the possibility of influencing protein synthesis at the gene level. Moreover, microRNAs of this class are highly sensitive biomarkers of various diseases, allowing not only to detect a disease at early asymptomatic stages, but also to predict therapeutic efficacy.
  • 1.0K
  • 17 Jun 2022
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