keyword
https://read.qxmd.com/read/38479561/phage-based-antibacterial-hydrogels-for-bacterial-targeting-and-ablation-progress-and-perspective
#21
REVIEW
Haoran Bai, Qinggele Borjihan, Zheng Li, Peiran Qin, Jingli Cheng, Douxin Xiao, Alideertu Dong
The emergence of drug-resistant bacteria makes antibiotics inadequate to treat bacterial infections, which is now a global problem. Phage as a virus with specific recognition ability can effectively kill the bacteria, which is an efficacious antibacterial material to replace antibiotics. Phage-based hydrogels have good biocompatibility and antibacterial effect at the site of infection. Phage hydrogels have remarkable antibacterial effects on targeted bacteria because of their specific targeted bactericidal ability, but there are few reports and reviews on phage hydrogels...
March 11, 2024: European Journal of Pharmaceutics and Biopharmaceutics
https://read.qxmd.com/read/38477405/host-cell-proteins-in-monoclonal-antibody-processing-control-detection-and-removal
#22
REVIEW
Takao Ito, Herb Lutz, Lihan Tan, Bin Wang, Janice Tan, Masum Patel, Lance Chen, Yuki Tsunakawa, Byunghyun Park, Subhasis Banerjee
Host cell proteins (HCPs) are process-related impurities in a therapeutic protein expressed using cell culture technology. This review presents biopharmaceutical industry trends in terms of both HCPs in the bioprocessing of monoclonal antibodies (mAbs) and the capabilities for HCP clearance by downstream unit operations. A comprehensive assessment of currently implemented and emerging technologies in the manufacturing processes with extensive references was performed. Meta-analyses of published downstream data were conducted to identify trends...
March 13, 2024: Biotechnology Progress
https://read.qxmd.com/read/38476206/a-window-for-enhanced-oral-delivery-of-therapeutics-via-lipid-nanoparticles
#23
REVIEW
Hilda Amekyeh, Rayan Sabra, Nashiru Billa
Oral administration of dosage forms is convenient and beneficial in several respects. Lipid nanoparticulate dosage forms have emerged as a useful carrier system in deploying low solubility drugs systemically, particularly class II, III, and IV drugs of the Biopharmaceutics Classification System. Like other nanoparticulate delivery systems, their low size-to-volume ratio facilitates uptake by phagocytosis. Lipid nanoparticles also provide scope for high drug loading and extended-release capability, ensuring diminished systemic side effects and improved pharmacokinetics...
2024: Drug Design, Development and Therapy
https://read.qxmd.com/read/38472689/fabrication-of-3d-printed-hydrocortisone-triple-pulsatile-tablet-using-fused-deposition-modelling-technology
#24
JOURNAL ARTICLE
Hao Chen, Kai Zheng, Tianshi Bu, Xin Li, Xiangyu Wang, Hao Pan
Hydrocortisone (HC) is the optimal drug for adolescents diagnosed with congenital adrenal hyperplasia (CAH). Because traditional dosage regimens HC are inconvenient, our study used fused deposition modeling (FDM) three-dimensional (3D) printing technology to solve the problems caused by traditional preparations. First, we designed a core-shell structure tablet with an inner instant release component and an outer delayed release shell. The instant release component was Kollicoat IR: glycerol (GLY): HC = 76...
March 12, 2024: AAPS PharmSciTech
https://read.qxmd.com/read/38472682/utilization-of-lipophilic-salt-and-phospholipid-complex-in-lipid-based-formulations-to-modulate-drug-loading-and-oral-bioavailability-of-pazopanib
#25
JOURNAL ARTICLE
Karan Jadhav, Arvind Sirvi, Akash Janjal, Mahesh C Kashyap, Abhay T Sangamwar
Pazopanib hydrochloride (PAZ) displays strong intermolecular interaction in its crystal lattice structure, limiting its solubility and dissolution. The development of lipid-based formulations (LbFs) resulted in reduced PAZ loading due to solid-state mediated low liposolubility. This study aims to enhance our understanding of PAZ crystallinity by synthesizing a lipophilic salt and phospholipid complex and investigating its impact on the drug loading in LbFs. The synthesized pazopanib lipophilic salt and phospholipid complex were extensively characterized...
March 12, 2024: AAPS PharmSciTech
https://read.qxmd.com/read/38472644/use-of-biosimilars-a-systematic-review-of-published-position-statements-and-recommendations-from-health-organisations-and-societies
#26
Noraisyah Mohd Sani, Zoriah Aziz, Adeeba Kamarulzaman
BACKGROUND: Hesitation about using biosimilars still exists among healthcare professionals (HCPs), despite extensive experience with their use. Globally, several health organisations and societies from various specialties have issued biosimilar position statements to guide the use of biosimilars in their specialties. However, it is uncertain how similar or different their positions or recommendations are or whether these positions have evolved with the increased experience and availability of new evidence...
March 12, 2024: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://read.qxmd.com/read/38472545/development-of-betulin-loaded-nanostructured-lipid-carriers-for-the-management-of-imiquimod-induced-psoriasis
#27
JOURNAL ARTICLE
Prativa Biswasroy, Deepak Pradhan, Dilip Kumar Pradhan, Goutam Ghosh, Goutam Rath
Psoriasis is a complex and persistent autoimmune skin disease. The present research focused on the therapeutic evaluation of betulin-loaded nanostructured lipid carriers (BE-NLCs) towards managing psoriasis. The BE-NLCs were synthesized using the emulsification cum solidification method, exhibiting a spherical shape with a particle size of 183.5±1.82nm and a narrow size distribution window (PDI: 0.142±0.05). A high zeta potential -38.64±0.05mV signifies the relative stability of the nano-dispersion system...
March 12, 2024: AAPS PharmSciTech
https://read.qxmd.com/read/38472523/preclinical-development-of-a-novel-epitope-based-dna-vaccine-candidate-against-sars-cov-2-and-evaluation-of-immunogenicity-in-balb-c-mice
#28
JOURNAL ARTICLE
Kanwal Khalid, Hui Xuan Lim, Ayaz Anwar, Soon Hao Tan, Jung Shan Hwang, Seng-Kai Ong, Chit Laa Poh
The protective efficacies of current licensed vaccines against COVID-19 have significantly reduced as a result of SARS-CoV-2 variants of concern (VOCs) which carried multiple mutations in the Spike (S) protein. Considering that these vaccines were developed based on the S protein of the original SARS-CoV-2 Wuhan strain, we designed a recombinant plasmid DNA vaccine based on highly conserved and immunogenic B and T cell epitopes against SARS-CoV-2 Wuhan strain and the Omicron VOC...
March 12, 2024: AAPS PharmSciTech
https://read.qxmd.com/read/38472091/high-yield-sterile-filtration-process-for-highly-concentrated-lentiviral-vectors
#29
JOURNAL ARTICLE
Jessica E Vogel, Monica Terrao, Sarah Schwingal, Laura Kapitza, Daniel Brigulla, Vicky Pirzas, Holger Laux, Tobias Brandt
The development and manufacture of biopharmaceuticals are subject to strict regulations that specify the required minimum quality of the products. A key measure to meet these quality requirements is the integration of a sterile filtration step into the commercial manufacturing process. Whereas common procedures for most biologics exist, this is challenging for lentiviral vector (LVV) production for ex vivo gene therapy. LVVs nominal size is more than half the pore size (0.2 µm) of filters used for sterile filtration...
March 2024: Biotechnology Journal
https://read.qxmd.com/read/38472072/prediction-of-antibody-production-performance-change-in-chinese-hamster-ovary-cells-using-morphological-profiling
#30
JOURNAL ARTICLE
Takumi Hisada, Yuta Imai, Yuto Takemoto, Kei Kanie, Ryuji Kato
Monoclonal antibodies (mAbs) represent a significant segment of biopharmaceuticals, with the market for mAb therapeutics expected to reach $200 billion in 2021. Chinese Hamster Ovary (CHO) cells are the industry standard for large-scale mAb production owing to their adaptability and genetic engineering capabilities. However, maintaining consistent product quality is challenging, primarily because of the inherent genetic instability of CHO cells. In this study, we address the need for advanced technologies for quality monitoring of host cells in biopharmaceuticals...
March 11, 2024: Journal of Bioscience and Bioengineering
https://read.qxmd.com/read/38472071/establishment-of-a-novel-cell-line-cho-mk-derived-from-chinese-hamster-ovary-tissues-for-biologics-manufacturing
#31
JOURNAL ARTICLE
Kenji Masuda, Michi Kubota, Yuto Nakazawa, Chigusa Iwama, Kazuhiko Watanabe, Naoto Ishikawa, Yumiko Tanabe, Satoru Kono, Hiroki Tanemura, Shinichi Takahashi, Tomohiro Makino, Takeshi Okumura, Takayuki Horiuchi, Koichi Nonaka, Sei Murakami, Masamichi Kamihira, Takeshi Omasa
Chinese hamster ovary (CHO) cells are widely used as a host for producing recombinant therapeutic proteins due to advantages such as human-like post-translational modification, correct protein folding, higher productivity, and a proven track record in biopharmaceutical development. Much effort has been made to improve the process of recombinant protein production, in terms of its yield and productivity, using conventional CHO cell lines. However, to the best of our knowledge, no attempts have been made to acquire new CHO cell lines from Chinese hamster ovary...
March 11, 2024: Journal of Bioscience and Bioengineering
https://read.qxmd.com/read/38471977/multi-dimensional-technology-recent-advances-and-applications-for-biotherapeutic-characterization
#32
REVIEW
Thomas Bouvarel, Julien Camperi, Davy Guillarme
This review provides an overview of the latest advancements and applications in multi-dimensional liquid chromatography coupled with mass spectrometry (mD-LC-MS), covering aspects such as inter-laboratory studies, digestion strategy, trapping column, and multi-level analysis. The shift from an offline to an online workflow reduces sample processing artifacts, analytical variability, analysis time, and the labor required for data acquisition. Over the past few years, this technique has demonstrated sufficient maturity for application across a diverse range of complex products...
March 2024: Journal of Separation Science
https://read.qxmd.com/read/38471403/can-biotechnology-lead-the-way-toward-a-sustainable-pharmaceutical-industry
#33
REVIEW
Deniz Etit, Samir Meramo, Ólafur Ögmundarson, Michael K Jensen, Sumesh Sukumara
The impact-intensive and rapidly growing pharmaceutical industry must ensure its sustainability. This study reveals that environmental sustainability assessments have been conducted for only around 0.2% of pharmaceuticals, environmental impacts have significant variations among the assessed products, and different impact categories have not been consistently studied. Highly varied impacts require assessing more products to understand the industry's sustainability status. Reporting all impact categories will be crucial, especially when comparing production technologies...
March 11, 2024: Current Opinion in Biotechnology
https://read.qxmd.com/read/38471384/targeting-trp-channels-for-pain-relief-a-review-of-current-evidence-from-bench-to-bedside
#34
REVIEW
Ari-Pekka Koivisto, Thomas Voets, Michael J Iadarola, Arpad Szallasi
Several decades of research support the involvement of transient receptor potential (TRP) channels in nociception. Despite the disappointments of early TRPV1 antagonist programs, the TRP family remains a promising therapeutic target in pain disorders. High-dose capsaicin patches are already in clinical use to relieve neuropathic pain. At present, localized injections of the side-directed TRPV1 agonist capsaicin and resiniferatoxin are undergoing clinical trials in patients with osteoarthritis and bone cancer pain...
March 11, 2024: Current Opinion in Pharmacology
https://read.qxmd.com/read/38471300/automatic-procedure-for-modelling-calibration-and-optimization-of-a-three-component-chromatographic-separation
#35
JOURNAL ARTICLE
Daniel Espinoza, Simon Tallvod, Niklas Andersson, Bernt Nilsson
The current landscape of biopharmaceutical production necessitates an ever-growing set of tools to meet the demands for shorter development times and lower production costs. One path towards meeting these demands is the implementation of digital tools in the development stages. Mathematical modelling of process chromatography, one of the key unit operations in the biopharmaceutical downstream process, is one such tool. However, obtaining parameter values for such models is a time-consuming task that grows in complexity with the number of compounds in the mixture being purified...
March 7, 2024: Journal of Chromatography. A
https://read.qxmd.com/read/38469705/efficacy-and-safety-of-antiplatelet-therapy-in-covid-19-insights-from-a%C3%A2-meta-analysis-of-randomized-controlled-trials
#36
JOURNAL ARTICLE
Guoying Kao, Yunlin Chen, Jinqi Fan
BACKGROUND: COVID-19 induces a pro-coagulant state with thrombotic events. This meta-analysis explores the efficacy and safety of antiplatelet-based therapy in COVID-19 patients through randomized controlled trials (RCTs). MATERIALS AND METHODS: A systematic literature search until March 10, 2023, identified 7 RCTs involving 23,415 inpatients. Of these, 11,891 received antiplatelet-based treatment, and 11,524 received placebo/other drugs. Statistical analysis was performed using Review Manager 5...
March 12, 2024: International Journal of Clinical Pharmacology and Therapeutics
https://read.qxmd.com/read/38468381/dod-combo-bayesian-dose-finding-design-in-combination-trials-with-meta-analytic-predictive-prior
#37
JOURNAL ARTICLE
Kai Chen, Yunqi Zhao, Meizi Liu, Jianchang Lin, Rachael Liu
Combination therapy, a treatment modality that involves multiple treatment agents, has become imperative for improving treatment effectiveness and addressing resistance in the field of oncology. However, determining the most effective dose for these combinations, particularly when dealing with intricate drug interactions and diverse toxicity patterns, presents a substantial challenge. This paper introduces a novel Bayesian <u>do</u>se-finding <u>d</u>esign for <u>comb</u>inati<u>o</u>n therapies with information borrowing, named the DOD-Combo design...
March 11, 2024: Journal of Biopharmaceutical Statistics
https://read.qxmd.com/read/38467336/antimicrobial-peptide-a-9-k-as-a-gene-delivery-vector-in-cancer-cells
#38
JOURNAL ARTICLE
Silvia Cirillo, Bo Zhang, Stephen Brown, Xiubo Zhao
Designed peptides are promising biomaterials for biomedical applications. The amphiphilic cationic antimicrobial peptide (AMP), A9 K, can self-assemble into nano-rod structures and has shown cancer cell selectivity and could therefore be a promising candidate for therapeutic delivery into cancer cells. In this paper, we investigate the selectivity of A9 K for cancer cell models, examining its effect on two human cancer cell lines, A431 and HCT-116. Little or no activity was instead observed on the control, human dermal fibroblasts (HDFs)...
March 9, 2024: European Journal of Pharmaceutics and Biopharmaceutics
https://read.qxmd.com/read/38467335/identification-of-structural-origins-of-complex-charge-heterogeneity-in-therapeutic-ace2fc-fusion-protein-facilitated-by-free-flow-isoelectric-focusing
#39
JOURNAL ARTICLE
Lingyu Wang, Hai Wu, Ting Cao, Hongyang Li, Pengcheng Shen, Lihong Lu, Zhongli Zhang
Fc Fusion protein represents a versatile molecular platform with considerable potential as protein therapeutics of which the charge heterogeneity should be well characterized according to regulatory guidelines. Angiotensin-converting enzyme 2 Fc fusion protein (ACE2Fc) has been investigated as a potential neutralizing agent to various coronaviruses, including the lingering SARS-CoV-2, as this coronavirus must bind to ACE2 to allow for its entry into host cells. ACE2Fc, an investigational new drug developed by Henlius (Shanghai China), has passed the Phase I clinical trial, but its huge amount of charge isoforms and complicated charge heterogeneity posed a challenge to charge variant investigation in pharmaceutical development...
March 9, 2024: European Journal of Pharmaceutics and Biopharmaceutics
https://read.qxmd.com/read/38467334/cyclodextrin-microneedles-for-the-delivery-of-a-nanoparticle-based-peptide-antigen-vaccine
#40
JOURNAL ARTICLE
Silvana Geisshüsler, Frida Nilsson, Nicole Ziak, Zuzanna Kotkowska, Marta Paolucci, Marina Green Buzhor, Nicole Zoratto, Pål Johansen, Jean-Christophe Leroux
In recent years, microneedles (MNs) have gained considerable interest in drug formulation due to their non-invasive and patient-friendly nature. Dissolving MNs have emerged as a promising approach to enhance drug delivery across the skin in a painless manner without generating sharp waste and providing the possibility for self-administration. Cyclodextrins, a group of cyclic oligosaccharides, are well-established in pharmaceutical products due to their safety and unique ability to form inclusion complexes with various drug molecules...
March 9, 2024: European Journal of Pharmaceutics and Biopharmaceutics
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