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 Tea Catechins in Chemoprevention for Prostate Cancer
Human PCa is a complex heterogeneous disease. The central driving forces of prostate carcinogenesis include acquisitions of diverse sets of hallmark capabilities, aberrant functioning of androgen receptor signaling, deregulation of vital cell physiological processes, inactivation of tumor-suppressive activity, and disruption of prostate gland-specific cellular homeostasis. Green tea is known for its health benefits deriving from molecules called green tea catechins (GTCs). GTCs have been demonstrated to influence molecular pathways to halt the progression of prostate cancer (PCa) and may be of particular benefit to men with low-risk PCa who are placed on active surveillance. Administering GTCs may provide patients an opportunity to be actively engaged in their treatment and help prevent cancer progression. Importantly, the trillions of microbes in the gut (the gut microbiome) metabolize GTCs, making them more accessible to the body to exert their health effects. Additionally, the gut microbiome influences multiple other processes likely involved in PCa progression, including regulating inflammation, hormones, and other known/unknown pathways. 
  • 1.1K
  • 01 Sep 2022
Topic Review
Trending Methods for Rapid Cannabinoids Detection
Roadside testing of illicit drugs such as tetrahydrocannabinol (THC) requires simple, rapid, and cost-effective methods. The need for non-invasive detection tools has led to the development of selective and sensitive platforms, able to detect phyto- and synthetic cannabinoids by means of their main metabolites in breath, saliva, and urine samples. One may estimate the time passed from drug exposure and the frequency of use by corroborating the detection results with pharmacokinetic data. Modified surfaces can also act as filters that allow only the target analyte to participate in the electrode reaction. In the case of cannabinoids, as in the case of other drugs, the investigation of the mechanism of action within the organism is the basis of biosensor development.
  • 1.4K
  • 18 Nov 2022
Topic Review
Nanocarriers Used in Co-Delivery Systems
The concept of the co-delivery approach first occurred from merging two research fields: drug delivery and gene therapy. Co-delivery systems combine at least two therapeutic agents with different physiological and physicochemical properties; thus, achieving clinical combination chemotherapy. Taking into consideration the co-delivery strategy, combination therapy via nanotechnology approaches has progressively become a desirable technique and one of the leading frontiers in research to find an efficient drug delivery system (DDS).
  • 1.5K
  • 29 Aug 2022
Topic Review
Polymeric Carriers
RNA therapeutics have gained popularity due to their ability to affect targets that small molecules cannot. Additionally, they can be manufacture more rapidly and cost-effectively than small molecules or recombinant proteins. RNA therapeutics can be synthesised chemically and altered quickly, which can enable a more personalised approach to treatment. Even though a wide range of RNA therapeutics are being developed for various indications, none has reached the clinic to date. One of the main reasons for this is attributed to the lack of safe and effective delivery systems for this type of therapeutic. Polymeric carriers have been widely studied for the delivery of RNA therapeutics because of their versatility, potential multi-functionality and relative low cost.
  • 1.3K
  • 29 Aug 2022
Topic Review
Application of mRNA Technology in Cancer Therapeutics
mRNA-based therapeutics pose as promising treatment strategies for cancer immunotherapy. Improvements in materials and technology of delivery systems have helped to overcome major obstacles in generating a sufficient immune response required to fight a specific type of cancer. Several in vivo models and early clinical studies have suggested that various mRNA treatment platforms can induce cancer-specific cytolytic activity, leading to numerous clinical trials to determine the optimal method of combinations and sequencing with already established agents in cancer treatment.
  • 956
  • 02 Sep 2022
Topic Review
Honey for Antimicrobial and Wound Healing Applications
Honey was used in traditional medicine to treat wounds until the advent of modern medicine. The rising global antibiotic resistance has forced the development of novel therapies as alternatives to combat infections. Consequently, honey is experiencing a resurgence in evaluation for antimicrobial and wound healing applications. A range of both Gram-positive and Gram-negative bacteria, including antibiotic-resistant strains and biofilms, are inhibited by honey. Furthermore, susceptibility to antibiotics can be restored when used synergistically with honey. Honey’s antimicrobial activity also includes antifungal and antiviral properties, and in most varieties of honey, its activity is attributed to the enzymatic generation of hydrogen peroxide, a reactive oxygen species. Non-peroxide factors include low water activity, acidity, phenolic content, defensin-1, and methylglyoxal (Leptospermum honeys). Honey has also been widely explored as a tissue-regenerative agent. It can contribute to all stages of wound healing, and thus has been used in direct application and in dressings. The difficulty of the sustained delivery of honey’s active ingredients to the wound site has driven the development of tissue engineering approaches (e.g., electrospinning and hydrogels). 
  • 2.7K
  • 29 Aug 2022
Topic Review
Relevance of Crystal Forms in the Pharmaceutical Field
The existence of multiple crystal forms of an active pharmaceutical ingredients (API) is relevant not only for the selection of the best solid material to carry through the various stages of drug development, including the choice of dosage and of excipients suitable for drug development and marketing, but also in terms of intellectual property protection and/or extension. This is because the physico-chemical properties, such as solubility, dissolution rate, thermal stability, processability, etc., of the solid API may depend, sometimes dramatically, on the crystal form, with important implications on the drug’s ultimate efficacy.
  • 1.9K
  • 26 Aug 2022
Topic Review
Sources of Extraction and Properties of Alginate
Alginate (ALG), a naturally abundant linear and anionic polysaccharide, is generally obtained from the cell wall of brown seaweed belonging to the class Phaeophyceae, including Ascophyllum nodosum, Laminaria hyperborea, Laminaria digitata, Laminaria japonica, and Microcystis pyrifera, and many bacterial strains, including Acetobacter and Pseudomonas spp. 
  • 1.7K
  • 25 Aug 2022
Topic Review
Supramolecular Adhesive Materials with Antimicrobial Activity
Taking advantage of the dynamic and reversible interactions such as hydrogen bonding, pi-pi stacking, electrostatic interactions, host-guest interactions, hydrophobic effects, and van der Waals interactions, a variety of functional supramolecular adhesive materials have been developed to realize tough bonding on tissues or organs. Non-covalent interactions are widely exploited and proved effective in developing supramolecular polymers and polymer composites with desired mechanical strength, interfacial adhesion, and intelligent, responsive properties. These supramolecular adhesive materials are promising for a range of biomedical applications.
  • 1.3K
  • 25 Aug 2022
Topic Review
Phototherapeutic Agents for Fabricating High Drug-Loading Nanomedicines
The key requirement of the chemo–photo combination therapy is the high drug-loading nanomedicines, which can load either chemotherapy drugs or phototherapy agents at the same nanomedicines and simultaneously deliver them to tumors, and play a multimode therapeutic role for tumor treatment. Many kinds of photothermal materials or photosensitizers have been used as carrier materials to construct high drug-loading nanomedicines for tumor combination therapy.
  • 1.5K
  • 26 Aug 2022
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