Current pharmaceutical biotechnology最新文献

{"title":"The Biological Effects of Nano-Curcumins against Drugs and Chemicals-Induced Nephrotoxicity: A Systematic Review.","authors":"Faramarz Beigi, Alizamen Salehifard Jouneghani, Saeid Heidari-Soureshjani, Catherine Mt Sherwin, Saeed Mohajeri","doi":"10.2174/0113892010360420250409111751","DOIUrl":"https://doi.org/10.2174/0113892010360420250409111751","url":null,"abstract":"<p><strong>Introduction/objective: </strong>Drug and chemical nephrotoxicity is a common cause of kidney disorders. This systematic review aimed to evaluate the recent progress in applying nanocurcumins (nano-CURs) to prevent and mitigate drug and chemical-induced nephrotoxicity, highlighting their underlying protective mechanisms and therapeutic potential.</p><p><strong>Methods: </strong>A comprehensive search of experimental and clinical studies was conducted in various databases, including Web of Science, PubMed/MEDLINE, Scopus, Embase, and Cochrane Library. The studies were analyzed for improvements in bioavailability, mechanisms of action, and outcomes in reducing kidney damage. After extracting the data and entering it into an Excel sheet, the essential information and the related knowledge on consequences and mechanisms were collected. The collected information was discussed and analyzed.</p><p><strong>Results: </strong>The antioxidant property of nano-CURs in dealing with nephrotoxicity is one of their most critical nephroprotective properties. They also exhibit potent anti-inflammatory, antiapoptotic, and anti-pyroptotic effects. Moreover, nano-CURs improve mitochondrial function, modulate kidney biochemical markers, modulate electrolyte imbalance, reduce endoplasmic reticulum (ER) stress, and improve kidney histopathological changes and autophagy, offering protection against nephrotoxicity induced by various drugs and chemicals. Nano-CURs significantly improve histopathological changes. Animal models have demonstrated reduced oxidative stress, inflammation, and apoptosis, causing improved renal function and histological outcomes.</p><p><strong>Conclusion: </strong>Nano-CURs have shown promising nephroprotective effects in experimental studies. However, these results have not been significant in clinical trial studies. Future research should focus on clinical trials and optimizing formulations for broader therapeutic applications.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Naringin Alleviates Digoxin-induced Nephrotoxicity via Regulating Nrf2/HO-1 and PI3K/ AKT/TGF-β Cascades in Rats' Renal Tissues.","authors":"Hoda K Said, Al Shaimaa Ibrahim Rabie, Amira S A Said, Mohammad M AlAhmad, Raghda R S Hussein, Mohamed Mady, Asmaa M El-Kalaawy, Khalid S Hashem, Amr E Ahmed","doi":"10.2174/0113892010340746250421065424","DOIUrl":"https://doi.org/10.2174/0113892010340746250421065424","url":null,"abstract":"<p><strong>Background: </strong>Nephrotoxicity limits the clinical application of digoxin. One area that might be useful is the mechanical knowledge of altered renal function and renal impairment. We hypothesized that co-administration of naringin would affect digoxin nephrotoxicity by alleviating the altered renal oxidative/ antioxidant redox and apoptotic cascade.</p><p><strong>Method: </strong>40 male Wistar Albino rats (200 ± 50 g) were grouped into 4, every group included (n= 7), control, Nar., Dig. and Nar. + dig. Groups. Colorimetric estimation of kidney functions and renal oxidative/ antioxidant redox were done.</p><p><strong>Results: </strong>Comparing digoxin alone, the concomitant administration of digoxin and naringin restored renal antioxidant/ oxidative redox, redistributed Nrf2, HO-1 mRNA exposure with a concomitant down-regulation of NF-κB, AKT and PI3K mRNA expressions. Moreover, a significant decrease of Smad3 and transforming growth factor-β (TGF- β) protein concentrations with a simultaneous rise of Smad7 were noticed in Nar. + dig. Arm when compared to Dig. group.</p><p><strong>Conclusion: </strong>The co-administration of naringin and digoxin can mitigate digoxin-mediated nephrotoxicity by introducing antioxidant action. This is done by maintaining effects on renal oxidative/antioxidant cycle and lethality via regulating AKT/ PI3k/ Smad3/ Smad7 signaling pathways.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144109934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Diagnosis and Treatment System for Neurological Psychological Gastrointestinal Diseases Based on Multimodal Artificial Intelligence and Immunology.","authors":"Liangyu Li, Jun Jiang, Lizhong Guo, Javier Santos, Ana María González, Siyi Li, Yi Qin","doi":"10.2174/0113892010359130250413024112","DOIUrl":"https://doi.org/10.2174/0113892010359130250413024112","url":null,"abstract":"<p><strong>Objective: </strong>To predict and assist in the treatment of colorectal cancer.</p><p><strong>Background: </strong>Precision medicine systems can provide strategy optimization for the diagnosis and treatment of colorectal cancer to meet the needs of clinical pricing institutions.</p><p><strong>Aim: </strong>To design an artificial intelligence multimodal gastrointestinal disease clinical information system based on neuroimmune gene regulation.</p><p><strong>Method: </strong>The system includes the use of cell gene expression levels to predict the 5-year survival rate of cancer patients, and the development of disease incidence rate prediction models based on immune cell status and living habits in somatic cell testing. The biological mechanism of feature selection in survival prediction systems was elucidated using single-cell sequencing technology, and this mechanism was analyzed in depth using molecular simulation techniques. Based on NCAM1 and CADM1 genes, biological activation pathway analysis was conducted to explore the biological mechanism of their synergistic immune genome regulation of gastrointestinal tumor proliferation.</p><p><strong>Result: </strong>The accuracy of each model is higher than 0.70. The experimental credibility is high.</p><p><strong>Conclusion: </strong>The research team conducted a detailed analysis of the biological characteristics of AI algorithms and reached a consensus with clinical experts. The ethical approval number of Chifeng Cancer Hospital is 202401, which has been reported by the World Health Organization.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143995968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sirtuins in Osteosarcoma: Cracking the Code and Opening Up New Treatment Options.","authors":"Yushi Zhao, Yong Han, Baichuan Wang, Ting Wang","doi":"10.2174/0113892010374421250419163509","DOIUrl":"https://doi.org/10.2174/0113892010374421250419163509","url":null,"abstract":"<p><p>Osteosarcoma (OS) is a frequent primary malignant bone tumor that primarily affects adolescents and the elderly, and it is prone to metastasis and recurrence. The prognostic status of metastatic and recurrent OS has remained stagnant over the past decades despite the availability of an extensive range of chemotherapy drugs in the clinic. To increase the overall survival and quality of life of patients with osteosarcoma, new therapeutic approaches must be developed immediately. In recent years, sirtuins (SIRT1-7) have garnered a lot of attention as researchers investigate the mechanisms underlying OS development and look for efficient treatment approaches. The nicotinamide adenine dinucleotide (NAD+)-dependent histone deacetylases (HDACs) that make up the sirtuin family are engaged in several biologically controlled processes, including proliferation, invasion, metastasis, apoptosis, autophagy, and chemotherapy resistance. Despite their significance in cancer having been avidly studied for decades, their specific functions and mechanisms of action are not yet clear due to limited reports. This review will summarize the current research status and look forward to the directions and prospects of its application in osteosarcoma research, aiming to open up new avenues for the treatment and study of osteosarcoma.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143955370","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Anti-Cancer Properties and Mechanistic Insights of Dihydroquercetin.","authors":"Cheng Zhang, Yuqiao Zeng, Bing Wu, Li Wang, Pengfei Wu, Ao Shen, Likun Wang","doi":"10.2174/0113892010366947250415051408","DOIUrl":"https://doi.org/10.2174/0113892010366947250415051408","url":null,"abstract":"<p><p>Dihydroquercetin (DHQ), also known as taxifolin, is a naturally occurring flavonoid compound that serves as an active pharmaceutical ingredient. It is commercially available in the form of dietary supplements. As the reduced form of quercetin, DHQ contains five phenolic hydroxyl groups. This compound is capable of chelating transition metal ions, thereby effectively scavenging free radicals and detoxifying harmful substances while modulating enzyme activities. Consequently, DHQ exhibits potent antioxidant, anti-inflammatory, antiviral, and antibacterial properties. Given its significant pharmacological potential, DHQ exhibits anti-tumor activity against various malignant tumors, including breast cancer, gastric cancer, hepatocellular carcinoma, colonic neoplasms, melanoma, and prostate cancer. DHQ inhibits tumor occurrence and progression by regulating multiple signaling pathways, such as wnt/β-catenin, phosphoinositide 3-kinase (PI3K)/protein kinase B (Akt), mammalian target of rapamycin (mTOR), transforming growth factor-beta (TGF-β), nuclear factor kappa-light-chain-enhancer of activated B cells (NF- κB), and mitogen-activated protein kinase (MAPK). The anti-tumor mechanisms of DHQ include inhibition of cell proliferation, invasion, and migration; induction of cell cycle arrest, activation of autophagy, apoptosis, epigenetic modification, suppression of epithelial-mesenchymal transition (EMT), enhancement of chemotherapy efficacy, and augmentation of immune function. In particular, DHQ potentiates the efficacy of chemotherapy drugs and augments immune function. Based on a systematic review of the pharmacological properties and anti-tumor mechanisms of DHQ across multiple malignant tumors, we conclude DHQ to be a promising natural compound with significant potential for anti-tumor therapy.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safflower Extract Mitigates MIRI in Rats by Modulating TLR-4/NF-κB Signaling Pathway, Demonstrating Protective Effects.","authors":"Mingling Deng, Jing Yang, Aimaiti Julaiti, Yue Dong, Yunfang Deng, Zhaoju Wang","doi":"10.2174/0113892010356035250417022534","DOIUrl":"https://doi.org/10.2174/0113892010356035250417022534","url":null,"abstract":"<p><strong>Background: </strong>Myocardial ischemia-reperfusion injury (MIRI) exacerbates tissue damage following the restoration of coronary blood flow after ischemia. The TLR-4/NF-κB signaling pathway plays a crucial role in the pathogenesis of MIRI. This study investigated the therapeutic efficacy of safflower extract in mitigating MIRI and its modulation of TLR-4/NF-κB signaling in rats.</p><p><strong>Methods: </strong>Adult male Sprague-Dawley rats were subjected to 30 minutes of myocardial ischemia followed by 2 h of reperfusion. Safflower extract was administered intravenously at doses of 2, 4, and 8 mg/kg 15 minutes before ischemia and 1 minute before reperfusion. Infarct size was assessed using TTC staining. Serum levels of creatine kinase (CK) and lactate dehydrogenase (LDH) were measured. Pro-inflammatory cytokines (IL-1β, IL-6, and TNF-α) were quantified using ELISA. TLR-4 and NF-κB mRNA and protein expression were evaluated using qRT-PCR and western blotting, respectively. Histopathological changes were assessed using H&E staining.</p><p><strong>Results: </strong>Safflower extract effectively reduced myocardial infarct size in a dose-dependent manner, with the highest dose providing the greatest benefit. Treatment with safflower extract significantly lowered the elevated levels of serum CK and LDH caused by ischemia-reperfusion (I/R) injury, bringing these biochemical markers closer to normal values. In addition, safflower extract decreased the levels of pro-inflammatory cytokines IL-1β, IL-6, and TNF-α in myocardial tissue, showing a clear dose-response relationship. Analysis through qRT-PCR and western blot confirmed that safflower extract downregulated the expression of TLR4 and NF-κB at both the transcriptional and protein levels. Histological studies further supported these findings, demonstrating that safflower extract improved myocardial tissue architecture, maintained cardiomyocyte structure, and reduced inflammatory cell infiltration.</p><p><strong>Conclusions: </strong>Safflower extract provides significant cardioprotection against MIRI by modulating the TLR-4/NF-κB-mediated inflammatory response. These findings suggest that safflower extract may be a potential therapeutic agent for mitigating the effects of myocardial ischemiareperfusion injury.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Baicalin-Targeted ZHX2/MMP14 Axis Attenuates Cirrhotic Portal Hypertension.","authors":"Hui Wang, Jiawei Ma, Jinghe Liu, Xiao Liu, Xiao Cai, Yufei Chang","doi":"10.2174/0113892010349745250416105433","DOIUrl":"https://doi.org/10.2174/0113892010349745250416105433","url":null,"abstract":"<p><strong>Background: </strong>Given the high mortality associated with Cirrhotic Portal Hypertension (CPH) worldwide, this study investigates the mechanism by which baicalin (BA), known for its beneficial effects on cirrhosis, alleviates CPH.</p><p><strong>Methods: </strong>The CPH model was established in Sprague-Dawley (SD) rats, followed by 4-week oral administration of 30 and 60 mg/kg/day BA. SD rats were randomly assigned to four groups (n=6/group): Con, Model, BA-30, and BA-60. Portal vein smooth muscle cells (PVSMCs, extracted from SD rats, n=6) were incubated with 5, 10 and 20 μmol/L BA. The levels of liver function indicators and von Willebrand factor (vWF) were determined by biochemical and immunohistochemical analyses, respectively. The portal pressure (PP) was examined. The liver fibrosis was detected by Sirius red staining. The levels of fibrosis-, angiogenesis- and proliferation- related indicators, zinc fingers and homeoboxes 2 (ZHX2), and matrix metallopeptidase 14 (MMP14) were quantified by Western blot. The levels of and interaction between ZHX2 and MMP14 were separately measured by quantitative real-time polymerase chain reaction (qRTPCR) and luciferase reporter assay. The proliferation and migration of PVSMCs were assessed by EdU staining and scratch test, respectively.</p><p><strong>Results: </strong>BA up-regulated ZHX2 and down-regulated MMP14 (P<0.001). BA concentrationdependently suppressed liver fibrosis, PP, and angiogenesis in the liver tissue, as well as PVSMC proliferation and migration, while enhancing liver function (P<0.05). Further, according to the GRNdb database and luciferase reporter assay, ZHX2 is bound with the promoter of MMP14. ZHX2 could suppress the MMP14 level (P<0.001). ZHX2 silencing reversed the effects of BA treatment on the proliferation and migration of PVSMCs, whereas MMP14 silencing could further offset the role of ZHX2 silencing in the BA-treated PVSMCs (P<0.05).</p><p><strong>Conclusion: </strong>BA up-regulates ZHX2 to reduce the level of MMP14 and alleviate CPH. Understanding the mechanisms of BA in CPH may provide a foundation for novel interventions to attenuate CPH.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Selenium Alleviates Oxidative Stress and Inflammation to Promote Postpartum Uterine Recovery via GPX1/GPX4/NRF2 Pathway in Mice.","authors":"Xiangping Li, Peng Li, Pingzhi Wang","doi":"10.2174/0113892010371042250416035948","DOIUrl":"https://doi.org/10.2174/0113892010371042250416035948","url":null,"abstract":"<p><strong>Background: </strong>Selenium is an important trace element that plays crucial roles in metabolism, immune function, and antioxidant defense. As an antioxidant, selenium helps to alleviate postpartum uterine inflammation and promotes uterine recovery. However, the exact mechanism underlying the role of selenium in postpartum uterine recovery is not fully understood.</p><p><strong>Objective: </strong>This study aimed to identify the underlying mechanism and examine how selenium enhances postpartum uterine healing.</p><p><strong>Methods: </strong>Female ICR mice aged 8 weeks were classified into five groups: control, postpartum model, low-dose selenium (100 nm), medium-dose selenium (200 nm), and high-dose selenium (400 nm). Endometrial morphology was evaluated by hematoxylin and eosin (H&E) staining. Oxidative stress markers, including superoxide dismutase (SOD), catalase (CAT), glutathione peroxidase (GPX), and malondialdehyde (MDA), and inflammatory factors, including tumor necrosis factor-alpha (TNF-α) and interleukin-1 beta (IL-1β), were measured using commercially available kits. GPX1, GPX4, and nuclear factor erythroid 2-related factor 2 (NRF2) expression were determined using real-time PCR and WB.</p><p><strong>Results: </strong>We found damage and bleeding points in the endometrium and destruction of the ultrastructure of endometrial cells in the postpartum model group; however, mice treated with a high dose (400 nm) of selenium showed alleviated levels of pathological alteration in the endometrium. In addition, the levels of MDA in the postpartum mice group increased, while the SOD, CAT, and GPX levels decreased; however, changes in these oxidative stress markers were reversed after selenium treatment. For inflammatory factors, high levels of TNF-α and IL-1β were observed in postpartum mice, whereas they were decreased in selenium-treated groups. GPX1, GPX4, and NRF2 expression were reduced in postpartum model mice, but upregulated in selenium- treated mice.</p><p><strong>Conclusion: </strong>Selenium supplementation ameliorated postpartum uterine oxidative stress and inflammation and promoted uterine recovery via the GPX1/GPX4/NRF2 pathway in mice.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143993048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potential Pharmacological Ability of a Novel Marine Polysaccharide Extracted from Tunisian Green Algae Chaetomorpha aerea to Accelerate Dermal Wound Healing in Rats.","authors":"Marwa Kraiem, Malek Eleroui, Zakaria Boujhoud, Marwa Ajala, Marwa Bouhamed, Abderraouf Hilali, Hatem Kallel, Ibtissem Ben Amara","doi":"10.2174/0113892010309000240912110548","DOIUrl":"https://doi.org/10.2174/0113892010309000240912110548","url":null,"abstract":"<p><strong>Background: </strong>Bacterial infection and oxidative stress generation are significant obstacles to dermal wound healing. The present study undertakes the isolation of a sulfated polysaccharide from the Tunisian green algal \"Chaetomorpha aerea\" named PCA.</p><p><strong>Methods: </strong>The polysaccharide PCA was structurally characterized using Fourier Transformed Infrared (FT-IR), and monosaccharide analysis was carried out by HPLC-FID X-ray diffraction (XRD) and Scanning Electron Microscopy (SEM). The antioxidant potential of polysaccharides extracted from the Chaetomorpha area was evaluated in vitro using various antioxidant assays, and the antibacterial activity of PCA against four Gram-negative bacteria was estimated. The wound healing capacity of PCA was evaluated in vivo using an excision wound model in rats.</p><p><strong>Results: </strong>FT-IR spectra revealed the characteristic bands of polysaccharides. HPLC-FID revealed a heteropolysaccharide composed of arabinose, glucose, glucuronic acid, and galactose units. Indeed, the X-ray diffraction revealed a semi-crystalline structure of PCA. The obtained data showed a strong antioxidant capacity and an interesting antibacterial activity against four-gram negative bacteria Escherichia coli, Acinetobacter baumannii, Klebsiella pneumonia, and Pseudomonas aeruginosa. These biological data strongly support the beneficial effects of PCA in accelerating wound healing in rats. The in vivo study on rats demonstrated that PCA significantly accelerated the wound healing process over an 11-day treatment period. The application of PCA on wounds led to enhanced collagen fiber synthesis, as evidenced by histological staining, which showed increased collagen deposition at the wound site. Additionally, PCA treatment resulted in faster wound closure, with measurements showing a marked reduction in wound size compared to control groups.</p><p><strong>Conclusion: </strong>The present study highlights the promising pharmacological effects of PCA, suggesting its potential application in wound dressings due to its robust antioxidant, antibacterial, and wound-healing properties.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972946","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Challenges and Pathways in Regulating Next-Gen Biological Therapies.","authors":"Surendra Agrawal, Sunita Vaidya, Jitendra Patel, Pranita Jirvankar, Pravina Gurjar","doi":"10.2174/0113892010367028250411111549","DOIUrl":"https://doi.org/10.2174/0113892010367028250411111549","url":null,"abstract":"<p><strong>Background: </strong>Current medicine could benefit from gene and cell therapies for genetic defects, cancer, and degenerative disorders. These therapies modify genetic material or biological components. CRISPR-Cas9 gene editing, stem cell, and CAR-T treatments are examples. Complex products need rigorous regulations to ensure quality, efficacy, and patient safety.</p><p><strong>Objectives: </strong>This paper discusses international gene and cell-based treatment regulatory regimes, highlighting key issues and recent developments. It also includes gene and cell-based therapy classes and mechanisms.</p><p><strong>Method: </strong>The publications on gene and cell therapy challenges and their regulatory approvals in the US, Europe, Japan, Australia, Brazil, Canada, and China were collected over the last 20 years from PubMed, Scopus, and Google Scholar and analyzed to determine the differences.</p><p><strong>Results: </strong>Gene treatments correct genetic defects or disease processes by adding, removing, or changing cell genetic information. In contrast, cell-based therapies restore damaged tissues with modified or unmodified cells. Highly customized and patient-specific drugs make regulatory monitoring challenging. US FDA CBER controls gene and cell-based therapies. Before clinical trials, these biologic drugs must file BLAs for market approval and INDs.</p><p><strong>Discussion: </strong>FDA's Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations accelerate biological development. The EMA oversees EU Advanced Therapy Medicinal Products. ATMP quality, safety, and efficacy are CAT's top priorities. The Conditional Marketing Authorization process expedites access to life-threatening disease medicines while the MAA regulates them. Japan's PMDA's Conditional Time-Limited Approval for regenerative medicines provides early commercialization and rigorous post-market supervision. Similarly, each country has adopted some ways to expedite the approval of biologicals. Geneediting drugs require specialized methods, long-term follow-up, and better safety to avoid offtarget effects. GMPs ensure production uniformity, sterility, and safety, complicating manufacturing and quality control.</p><p><strong>Conclusion: </strong>The review concludes that there is a need for worldwide regulatory harmonization and regulatory framework developments, including R.W.E., adaptive pathways, and personalization of biologics.</p>","PeriodicalId":10881,"journal":{"name":"Current pharmaceutical biotechnology","volume":" ","pages":""},"PeriodicalIF":2.2,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143994129","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}