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
Hyaluronic Acid-Conjugated Carbon Nanomaterials
Hyaluronic acid (HA) has been implemented for chemo and photothermal therapy to target tumour cells overexpressing the CD44+ receptor. HA-targeting hybrid systems allows carbon nanomaterial (CNM) carriers to efficiently deliver anticancer drugs, such as doxorubicin and gemcitabine, to the tumour sites. 
  • 614
  • 07 Jan 2022
Topic Review
Interfacial Adsorption of Bioengineered Monoclonal Antibodies
Monoclonal antibodies (mAbs) are an important class of biotherapeutics. MAbs, like any globular protein, are amphiphilic and readily adsorb to interfaces, potentially causing structural deformation and even unfolding. Desorption of structurally perturbed mAbs is often hypothesized to promote aggregation, potentially leading to the formation of subvisible particles and visible precipitates. Since mAbs are exposed to numerous interfaces during biomanufacturing, storage and administration, many studies have examined mAb adsorption to different interfaces under various mitigation strategies. 
  • 488
  • 05 Jan 2022
Topic Review
Plant Cell Culture
The large-scale production of plant-derived secondary metabolites (PDSM) in bioreactors to meet the increasing demand for bioactive compounds for the treatment and prevention of degenerative diseases is nowadays considered an engineering challenge. Plant cell culture (PCC) is nowadays recognized as a promising, renewable, sustainable, and environmentally friendly alternative to obtain PDSM out of wild plants. PCC accounts for the virtues of whole-plant cultivation systems and offers significant advantages, such as controlled manufacture due to standardized environmental conditions, i.e., it is not seasonal dependent, makes use of low amounts of water, and pesticides and herbicides are not required, achieving better quality in the desired product.
  • 2.2K
  • 29 Dec 2021
Topic Review
Silica Hydride
The silica hydride surface is composed of silicon-hydrogen groups, which is much more stable, less reactive and delivers different chromatographic and chemical characteristics.
  • 1.1K
  • 27 Dec 2021
Topic Review
CD44
CD44, a non-kinase cell surface transmembrane glycoprotein, has been widely implicated as a cancer stem cell (CSC) marker in several cancers. Cells overexpressing CD44 possess several CSC traits, such as self-renewal and epithelial-mesenchymal transition (EMT) capability, as well as a resistance to chemo- and radiotherapy.
  • 878
  • 28 Dec 2021
Topic Review
RNA-Based Vaccines
Vaccine development using ribonucleic acid (RNA) has become the most promising and studied approach to produce safe and effective new vaccines, not only for prophylaxis but also as a treatment. The use of messenger RNA (mRNA) as an immunogenic has several advantages to vaccine development compared to other platforms, such as lower coast, the absence of cell cultures, and the possibility to combine different targets.
  • 534
  • 24 Dec 2021
Topic Review
Induced Nephron Progenitor-like Cells from Human Urine-Derived Cells
Chronic kidney disease (CKD) has emerged as a major public health concern due to its prevalence in 7–12% of the population worldwide, progression to irreversible end-stage renal disease (ESRD), impaired quality of life, associations with high social and financial costs, and high rates of associated morbidity and mortality (an 82% increase in CKD epidemic over the past two decades). The current treatment options for kidney failure involve lifelong dialysis and whole kidney transplantation. Although kidney transplantation undoubtedly offers a better quality of life and life expectancy than dialytic treatment, it is limited by the scarcity of available organs and the huge gap between supply and demand. Furthermore, considering that the average life expectancy of dialysis patients is barely a decade, alternative strategies for preventing or delaying the progression to ESRD are urgently needed. In this context, regenerative medicine strategies employing nephron progenitor cells (NPCs) are a viable approach that is worthy of substantial consideration as a promising cell source for kidney diseases. However, the generation of induced nephron progenitor-like cells (iNPCs) from human somatic cells remains a major challenge.
  • 529
  • 24 Dec 2021
Topic Review
Bacterial Ghosts-Based Vaccine
Bacterial ghosts (BGs) are empty bacterial envelopes of Gram-negative bacteria produced by controlled expressions of cloned gene E, forming a lysis tunnel structure within the envelope of the living bacteria.
  • 742
  • 22 Dec 2021
Topic Review
Surface Plasmon Resonance-Based Biosensors for Advanced Bioprocess Monitoring
Biomanufacturers are being incited by regulatory agencies to transition from a quality by testing framework, where they extensively test their product after their production, to more of a quality by design or even quality by control framework. This requires powerful analytical tools and sensors enabling measurements of key process variables and/or product quality attributes during production, preferably in an online manner. As such, the demand for monitoring technologies is rapidly growing. In this context, researchers believe surface plasmon resonance (SPR)-based biosensors can play a role in enabling the development of improved bioprocess monitoring and control strategies.
  • 824
  • 22 Dec 2021
Topic Review
Anti-Cancer Role and Therapeutic Potential of Extracellular Vesicles
Cell–cell communication is an important mechanism in biological processes. Extracellular vesicles (EVs), also referred to as exosomes, microvesicles, and prostasomes, are microvesicles secreted from a variety of cells. Importantly, EVs contribute to cancer malignancy mechanisms such as carcinogenesis, proliferation, angiogenesis, metastasis, and escape from the immune system. As EVs are thought to be secreted into body fluids, they have the potential to serve as diagnostic markers for liquid biopsy. In addition, the characteristics of EVs make them suitable for use in drug delivery systems and novel cancer treatments. 
  • 486
  • 22 Dec 2021
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