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
Single B Cell Co-Expression Networks in Lung Cancer
In non-small cell lung cancer (NSCLC), there is a pressing need for immunotherapy predictive biomarkers. The processes underlying B-cell dysfunction, as well as their prognostic importance in NSCLC, are unknown. This study presents novel insights on a dysregulated B cell network that promotes proliferation in epithelial cells in NSCLC. Within this network, a nine-gene signature demonstrated prognostic and predictive indications in more than 1400 NSCLC patients using their gene and protein expression profiles in bulk tumors. Multiple genes (HLA-DRA, HLA-DRB1, OAS1, and CD74) differentially expressed in NSCLC B cells, peripheral blood lymphocytes, and tumor T cells had concordant prognostic indications at mRNA and protein expression levels. 
  • 562
  • 28 Jun 2022
Topic Review
Nucleic Acid Aptamers in Nanotechnology
Nucleic Acid (NA) aptamers are oligonucleotides. They are unique due to their primary (nucleotide sequence) and, therefore, secondary and tertiary structure. The structure of the previous order defines the propensity to form the successive one. In other words, primary (sequence) defines secondary (ability to adopt certain structures at certain conditions). The secondary define the tertiary one by means of affinity and specificity. The length of aptamers is similar to the length of PCR primers, and therefore the technology for the primers manufacturing is useful for aptamers synthesis. 
  • 455
  • 27 Jun 2022
Topic Review
Developments in Innovative Detection Methods in Complex Samples
New microbiological quality control methods have emerged, some of which have been shown to deliver results in shorter periods than conventional ones, opening the possibility of earlier corrective actions. In particular, removing the culture step provides faster or even real-time results. Moreover, these new innovative techniques can improve the sensitivity, correlated with the limit of detection (LOD), and/or the specificity, i.e., reducing false positive. Other developments include facilitating automation or reducing either the size or the cost of the device.
  • 392
  • 27 Jun 2022
Topic Review
Overall Features of Transdermal Drug Delivery
Transdermal Drug Delivery System (TDDS) is an alternative approach that allows the drug to permeate through skin and enter the systemic circulation, minimizing or avoiding the limitations of oral and parenteral formulations.
  • 660
  • 24 Jun 2022
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.
  • 337
  • 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.
  • 384
  • 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.
  • 812
  • 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.
  • 406
  • 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. 
  • 416
  • 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.
  • 288
  • 20 Jun 2022
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