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
Green Synthesis of Gold Nanoparticles (AuNPs) from Plants
Gold nanoparticles (AuNPs) are becoming promising cancer therapeutic and diagnostic metal NPs that attract researchers due to their unique physiochemical properties such as stability, biocompatibility, high thermal activity, optical, electrical, high surface area to volume ratio surface chemistry, and multifunctionalization, etc. By fine tuning the components and concentrations, AuNPs can be easily manufactured into various forms and sizes. AuNPs have also shown significant advancement in treating inflammatory diseases and bacterial infections.
  • 975
  • 02 Nov 2021
Topic Review
Tyrp1 Mutant Variants and OCA3
Oculocutaneous albinism type 3 (OCA3) is an autosomal recessive disorder caused by mutations in the TYRP1 gene. Tyrosinase-related protein 1 (Tyrp1) is involved in eumelanin synthesis, catalyzing the oxidation of 5,6-dihydroxyindole-2-carboxylic acid oxidase (DHICA) to 5,6-indolequinone-2-carboxylic acid (IQCA).
  • 505
  • 29 Oct 2021
Topic Review
Chitosan Composites
This topic discusses the properties of chitosan, which is synthesized from the biopolymer named chitin. Chitin is available in nature in abundance. Chitosan is a biodegradable polymer with other biological properties like antioxidant and antimicrobial properties. The polymer and its derivatives are nonimmunogenic and noninflammatory. Due to their advantages, these polymers have received much attention in the food and pharmaceutical industries. In the present topic, the sources of chitosan and their properties will be discussed in brief.
  • 947
  • 29 Oct 2021
Topic Review
Hydroxyapatite Nanoparticles in Drug Delivery
A biomaterial is a synthetic material used to replace part of a living system or a material meant to be in contact with living tissue. In this sense, biomaterials can be categorized into polymers, liposomes, micelles, dendrimers, and calcium phosphate (CaP) nanoparticles, where each will show a different type of bioactivity. Hydroxyapatite (HAP) has been the gold standard in the biomedical field due to its composition and similarity to human bone. HAP nanoparticles have been used as vehicles for delivery due to their affinity to DNA, proteins, several drugs, and proper release activity.
  • 823
  • 02 Nov 2021
Topic Review
Serotonin-Norepinephrine Reuptake Inhibitors
Serotonin-norepinephrine reuptake inhibitors (SNRIs) are among the most commonly prescribed medications in the United States annually. As their name suggests, the principle mechanism of action is the inhibition of presynaptic neuronal uptake of 5-HT (serotonin) and norepinephrine following release from the synaptic cleft.
  • 611
  • 28 Oct 2021
Topic Review
Cell-Scaffold Constructs for Bone Regeneration Therapy
Bone tissue engineering (BTE) is a process of combining live osteoblast progenitors with a biocompatible scaffold to produce a biological substitute that can integrate into host bone tissue and recover its function. Mesenchymal stem cells (MSCs) are the most researched post-natal stem cells because they have self-renewal properties and a multi-differentiation capacity that can give rise to various cell lineages, including osteoblasts. BTE technology utilizes a combination of MSCs and biodegradable scaffold material, which provides a suitable environment for functional bone recovery and has been developed as a therapeutic approach to bone regeneration.
  • 858
  • 28 Oct 2021
Topic Review
Role of PARP in TNBC
Triple-negative breast cancer is a combative cancer type with a highly inflated histological grade that leads to poor theragnostic value. Gene, protein, and receptor-specific targets have shown effective clinical outcomes in patients with TNBC. Cells are frequently exposed to DNA-damaging agents. DNA damage is repaired by multiple pathways; accumulations of mutations occur due to damage to one or more pathways and lead to alterations in normal cellular mechanisms, which lead to development of tumors. Advances in target-specific cancer therapies have shown significant momentum; most treatment options cause off-target toxicity and side effects on healthy tissues. PARP (poly(ADP-ribose) polymerase) is a major protein and is involved in DNA repair pathways, base excision repair (BER) mechanisms, homologous recombination (HR), and nonhomologous end-joining (NEJ) deficiency-based repair mechanisms. DNA damage repair deficits cause an increased risk of tumor formation. Inhibitors of PARP favorably kill cancer cells in BRCA-mutations. For a few years, PARPi has shown promising activity as a chemotherapeutic agent in BRCA1- or BRCA2-associated breast cancers, and in combination with chemotherapy in triple-negative breast cancer.
  • 597
  • 29 Oct 2021
Topic Review
ANO1 in Cystic Fibrosis
Cystic fibrosis (CF) is the most common of rare hereditary diseases in Caucasians, and it is estimated to affect 75,000 patients globally. CF is a complex disease due to the multiplicity of mutations found in the CF transmembrane conductance regulator (CFTR) gene causing the CFTR protein to become dysfunctional. Although CFTR is the main chloride channel in the lungs, others could, e.g., anoctamin-1 (ANO1 or TMEM16A), compensate for the deficiency of CFTR. 
  • 932
  • 26 Oct 2021
Topic Review
Safety Evaluation of Nanotechnology Products
Nanomaterials are now being used in a wide variety of biomedical applications. Medical and health-related issues, however, have raised major concerns, in view of the potential risks of these materials against tissue, cells, and/or organs and these are still poorly understood. These particles are able to interact with the body in countless ways, and they can cause unexpected and hazardous toxicities, especially at cellular levels. Therefore, undertaking in vitro and in vivo experiments is vital to establish their toxicity with natural tissues. 
  • 469
  • 25 Oct 2021
Topic Review
Novel Characterization in Radiopharmaceutical Preclinical Design
In this entry, the potential of a digital autoradiography system equipped with a super resolution screen has been evaluated to investigate the biodistribution of a 18F-PSMA inhibitor in a prostate cancer mouse model. Twelve double xenograft NOD/SCID mice (LNCAP and PC3 tumours) were divided into three groups according to post-injection time points of an 18F-PSMA inhibitor. Groups of 4 mice were used to evaluate the biodistribution of the radiopharmaceutical after 30-, 60- and 120-min post-injection. Data here reported demonstrated that the digital autoradiography system is suitable to analyse the biodistribution of an 18F-PSMA inhibitor in both whole small-animal bodies and in single organs. The exposure of both whole mouse bodies and organs on the super resolution screen surface allowed the radioactivity of the PSMA inhibitor distributed in the tissues to be detected and quantified. Data obtained by using a digital autoradiography system were in line with the values detected by the activity calibrator. In addition, the image obtained from the super resolution screen allowed a perfect overlap with the tumour images achieved under the optical microscope. In conclusion, biodistribution studies performed by the autoradiography system allow the microscopical modifications induced by therapeutic radiopharmaceuticals to be studied by comparing the molecular imaging and histopathological data at the sub-cellular level. 
  • 493
  • 22 Oct 2021
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