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
CRABP1
The emerging role of Cellular Retinoic Acid Binding Protein 1 (CRABP1) as a mediator of non-canonical activities of retinoic acid (RA) and relevance to human diseases.
  • 1.3K
  • 21 Apr 2022
Topic Review
Synthesis, Characterization, and Applications of Bioactive Metallic Nanoparticles
Nanoparticles (NPs) are elements derived from a cluster of atoms with one or more dimensions in the nanometer scale in the range of 1–100 nm. The bio nanofabrication of metallic NPs is now an important dynamic area of research, with major significance in applied research. Biogenic synthesis of NPs is more desirable than physical and chemical synthesis due to its eco-friendliness, non-toxicity, lower energy consumption, and multifunctional nature. Plants outperform microorganisms as reducing agents as they contain large secondary biomolecules that accelerate the reduction and stability of the NPs. The produced NPs can then be studied spectroscopically (UV-Visible, XRD, Raman, IR, etc.) and microscopically (SEM, TEM, AFM, etc.). The biological reduction of a metallic ion or its oxide to a nanoparticle is quick, simple, and maybe scaled up at room temperature and pressure. The rise in multi-drug resistant (MDR) microbes due to the immoderate use of antibiotics in non-infected patients is a major cause of morbidity and mortality in humans. The contemporary development of a new class of antibiotics with different mechanisms of action to kill microbes is crucial. Metals and their oxides are extremely toxic to microbes at unprecedentedly low concentrations. In addition, prevailing infections in plants and animals are raising significant concerns across the globe. NPs’ wide range of bioactivity makes them ideal antimicrobial agents in agricultural and medical fields. The present research outlines the synthesis of metallic NPs from botanicals, which enables the metals to be in a stabilized form even after ionization. It also presents a valuable database on the biofunctionalization of synthesized NPs for further drug development.
  • 1.2K
  • 19 Apr 2022
Topic Review
Genus Decalepis
The steno-endemic species from the genus Decalepis are facing a high level of threat due to destructive wild harvesting. The genus claimed its paramount importance to mankind due to its unique tuberous root characteristics and exhibits a wide range of biological and medicinal properties, and is used in pharmaceutical and food industries. Plants of this genus are endemic to limited areas of peninsular India, such as the Eastern and Western Ghats, and according to the International Union for Conservation of Nature (IUCN), species from the genus Decalepis are considered globally critically endangered.
  • 861
  • 18 Apr 2022
Topic Review
Health Effects of Sweet Potato (Ipomoea batatas L.)
Sweet potato (SP; Ipomoea batatas (L.) Lam) is an edible tuber native to America and the sixth most important food crop worldwide. China leads its production in a global market of USD 45 trillion. SP domesticated varieties differ in specific phenotypic/genotypic traits, yet all of them are rich in sugars, slow digestible/resistant starch, vitamins, minerals, bioactive proteins and lipids, carotenoids, polyphenols, ascorbic acid, alkaloids, coumarins, and saponins, in a genotype-dependent manner. Individually or synergistically, SP’s phytochemicals help to prevent many illnesses, including certain types of cancers and cardiovascular disorders.
  • 2.2K
  • 18 Apr 2022
Topic Review
Tunicamycin in Breast Cancer Research
Tunicamycin is a small biological molecule, that blocks a specific step of the protein N-glycosylation pathway in the endoplasmic reticulum (ER), i.e., the catalytic activity of N-acetylglusosaminyl 1-phosphate transferase (GPT).
  • 891
  • 15 Apr 2022
Topic Review
A Nanoparticle’s Journey to the Tumor
Nanomedicines represent the cutting edge of today’s cancer therapeutics. Seminal research decades ago has begun to pay dividends in the clinic, allowing for the delivery of cancer drugs with enhanced systemic circulation while also minimizing off-target toxicity. Despite the advantages of delivering cancer drugs using nanoparticles, micelles, or other nanostructures, only a small fraction of the injected dose reaches the tumor, creating a narrow therapeutic window for an otherwise potent drug. First-pass metabolism of nanoparticles by the reticuloendothelial system (RES) has been identified as a major culprit for the depletion of nanoparticles in circulation before they reach the tumor site. To overcome this, new strategies, materials, and functionalization with stealth polymers have been developed to improve nanoparticle circulation and uptake at the tumor site. 
  • 924
  • 14 Apr 2022
Topic Review
Erythrocytes as Carriers of Therapeutic Enzymes
Therapeutic enzymes are biocatalyst drugs that bind to target substrates with a high affinity and specificity, catalyzing their conversion into their relevant products. The past five decades have seen the development of therapeutic enzymes for treating a wide range of medical conditions, including inherited enzyme deficiency disorders, acute poisoning, digestive disorders, cancer and cardiovascular diseases. Chemical modifications of the native enzyme (e.g., conjugation with polyethylene glycol) are often employed in the manufacturing process to increase protein stability, decrease immunogenicity, reduce renal ultrafiltration and in some cases, to enable targeting of the enzyme to the appropriate cellular compartment. The erythrocyte carrier has been extensively studied as a strategy for overcoming these limitations and increasing therapeutic efficacy. For a majority of the therapeutic applications investigated, the ability of the cell to reseal after creating pores in the membrane has been exploited for the purpose of introducing therapeutic agents.
  • 1.3K
  • 15 Apr 2022
Topic Review
Fluorescence Imaging for Biomedical Applications
Molecular imaging offers the possibility to investigate biological and biochemical processes non-invasively and to obtain information on both anatomy and dysfunctions. Based on the data obtained, a fundamental understanding of various disease processes can be derived and treatment strategies can be planned. In this context, methods that combine several modalities in one probe are increasingly being used. Due to the comparably high sensitivity and provided complementary information, the combination of nuclear and optical probes has taken on a special significance.
  • 1.3K
  • 13 Apr 2022
Topic Review
Extended Myc Network
Among the first discovered and most prominent cellular oncogenes is MYC, which encodes a bHLH-ZIP transcription factor (Myc) that both activates and suppresses numerous genes involved in proliferation, energy production, metabolism and translation. Myc belongs to a small group of bHLH-ZIP transcriptional regulators (the Myc Network) that includes its obligate heterodimerization partner Max and six “Mxd proteins” (Mxd1–4, Mnt and Mga), each of which heterodimerizes with Max and largely opposes Myc’s functions.
  • 1.2K
  • 13 Apr 2022
Topic Review
Biomedical Applications of MXenes
MXenes have emerged as a newer class of 2D materials that produce metallic conductivity upon interaction with hydrophilic species, and their delamination affords monolayer nanoplatelets of a thickness of about one nm and a side size in the micrometer range. Delaminated MXene has a high aspect ratio, making it an alluring nanofiller for multifunctional polymer nanocomposites. Moreover, MXenes are of special relevance in hydrogel-based applications because of their outstanding mechanical strength, extraordinary hydrophilicity and a distinct surface chemistry, which adds a new level of adaptability.
  • 1.4K
  • 15 Apr 2022
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