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
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.
  • 971
  • 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. 
  • 879
  • 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.
  • 710
  • 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.
  • 587
  • 26 Aug 2022
Topic Review
Hormone Therapy for Castration-Resistant Prostate Cancer
Prostate cancer (PCa) is the most common cancer and the second deadliest cancer among men in the United States, which is mainly due to metastatic disease. In general, surgery or radiation is potentially a curative treatment for localized disease. Since PCa is characterized as a typical androgen-dependent disease, hormone therapy (i.e., androgen deprivation therapy (ADT)) is the most effective therapy to control metastatic disease. However, almost all patients eventually develop castration-resistant PCa (CRPC) within 12 to 18 months, with a median survival of 14 to 26 months. Nowadays, new anti-androgens (Enzalutamide or Abiraterone), radiotherapy (Radium-223) or immunotherapy (sipuleucel-T) have been approved for metastatic CRPC (mCRPC) patients to prolong the overall survival. Inevitably, mCRPC further acquires resistance and becomes therapy- and castration-resistant PCa (t-CRPC), which is considered as an end-stage disease without effective therapy, and on which new therapeutic strategies have been actively explored.
  • 726
  • 24 Aug 2022
Topic Review
Nanoparticles in Cancer Theranostics
Cancer theranostics is the combination of diagnosis and therapeutic approaches for cancer, which is essential in personalized cancer treatment. The aims of the theranostics application of nanoparticles in cancer detection and therapy are to reduce delays in treatment and hence improve patient care. Recently, it has been found that the functionalization of nanoparticles can improve the efficiency, performance, specificity and sensitivity of the structure, and increase stability in the body and acidic environment. Moreover, functionalized nanoparticles have been found to possess a remarkable theranostic ability and have revolutionized cancer treatment.
  • 333
  • 24 Aug 2022
Topic Review
Nanoparticles-Based Platforms Targeting the PD-1/PD-L1 Pathway
Immune checkpoint inhibitors (ICIs) targeting the PD-1/PD-L1 axis showed remarkable improvements in overall response and patient survival, which changed the treatment landscape for multiple cancer types. PD-1/PD-L1-targeted agents encapsulated in nanoparticles have emerged as novel drug delivery systems for improving the delivery efficacy, enhancing immune response and minimizing side effects in cancer treatment. Nanocarriers targeting the PD-1/PD-L1 axis showed enhanced functionalities and improved technical weaknesses based on their reduced off-target effects, biocompatible properties, multifunctional potential and biomimetic modifications. 
  • 532
  • 24 Aug 2022
Topic Review
Delivery Platforms for miRNA-Based Cancer Therapeutics
Restoration of microRNA (miRNA) expression or downregulation of aberrantly expressed miRNAs using miRNA mimics or anti-miRNA inhibitors (anti-miRs/antimiRs), respectively, continues to show therapeutic potential for the treatment of cancer. Although the manipulation of miRNA expression presents a promising therapeutic strategy for cancer treatment, it is predominantly reliant on nucleic acid-based molecules for their application, which introduces an array of hurdles, with respect to in vivo delivery. Because naked nucleic acids are quickly degraded and/or removed from the body, they require delivery vectors that can help overcome the many barriers presented upon their administration into the bloodstream.
  • 1.1K
  • 25 Aug 2022
Topic Review
Medicinal Plants of the Himalayas
WHO recommends cancer is the leading cause of death worldwide, with nearly 10 million deaths predicted in 2020(1). The bioactivities of phytocompounds for various health benefits have been studied for decades. Synthetic drugs are being replaced by phytocompounds which have great advantages due to their effects on a wide range of target cells with lower cell cytotoxicity effects or side effects compared to synthetic anticancer compounds, which are a single-target effect for prevention and treatment of carcinoma. Various medicinal plants and their nanoparticles have anticancer activity, namely Murraya koenigii leaf extract ZnO nanoparticlets. Most modern drugs used to treat cancer originate from various medicinal plants; 50% of the anticancer drugs originate from medicinal plants. In developing countries, more than 80% of people use medicinal plants as traditional medicinal therapy and 60% of cancer patients use herbal treatment as an option to cure cancer. Currently, for high-risk breast cancer patients, tamoxifen and related compounds such as raloxifene are prescribed. The phytocompounds most studied in different research papers for the treatment of cancer (anti-proliferative activity) are curcumin, polyphenols, Withaferin A (WFA), a triterpenoid, celastrol, and berry bioactives. Vinca alkaloids, podophyllotoxin, taxanes, campothecin, homoharringtonine, saponin, isoquinoline, shatavarine IV, stigamsterola, calotropin, and shikonin phytocompounds are discussed as follows. Cancer as well as boosting the immune system.
  • 419
  • 22 Aug 2022
Topic Review
Efficacy of Auto-CAR T Cell Therapy in Lymphoma
While more than half of non-Hodgkin lymphomas (NHL) can be cured with modern frontline chemoimmunotherapy regimens, outcomes of relapsed and/or refractory (r/r) disease in subsequent lines remain poor, particularly if considered ineligible for hematopoietic stem cell transplantation. Hence, r/r NHLs represent a population with a high unmet medical need. This therapeutic gap has been partially filled by adoptive immunotherapy. CD19-directed autologous chimeric antigen receptor (auto-CAR) T cells have been transformative in the treatment of patients with r/r B cell malignancies.
  • 382
  • 19 Aug 2022
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