Biologics : Targets & Therapy最新文献

{"title":"Generalized Pustular Psoriasis with Cushing's Syndrome: A Case of Effective Spesolimab Treatment.","authors":"Guoyao Peng, Yun Zhang, Shuang Zhang, You Li, Liping Luo, Jiaxin Luo, Xinyi Nie, Hongwei Zhang, Chengcheng Liao","doi":"10.2147/BTT.S521363","DOIUrl":"https://doi.org/10.2147/BTT.S521363","url":null,"abstract":"<p><p>Generalized pustular psoriasis (GPP) is a rare neutrophilic skin disease characterized by persistent symptoms and sudden onset of painful, sterile pustules. These pustules may be accompanied by systemic inflammation and can be life-threatening in severe cases. Presently, there is an absence of standardized guidelines for treatment, and the majority of conventional treatments employed by clinicians are predicated on the utilization of glucocorticosteroids, immunosuppressants, and retinoids to attain anti-inflammatory and immune-suppressing effects. However, the therapeutic effect is often unsatisfactory and patients are prone to side effects. The IL-36 receptor monoclonal antibody, Spesolimab, signifies a novel therapeutic modality that has received approval from both the National Drug Administration (NMPA) of China and the US Food and Drug Administration (FDA) for the management of acute exacerbations of GPP. We report a case of a 40-year-old male patient diagnosed with GPP who had no significant improvement in symptoms and development of Cushing's syndrome after up to six months of treatment with glucocorticoids, immunosuppressants, and retinoids. The patient was treated with Spesolimab, a monoclonal antibody, resulting in a substantial improvement in symptoms. This development offers novel treatment options and provides a reference for clinical medication for patients with this particular type of GPP.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"321-329"},"PeriodicalIF":5.3,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12077406/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144075954","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>Boswellia carteri</i> Birdw. Resin Extract Induces Phase-I Cytochrome P-450 Enzyme Gene Expressions in Human Hepatocarcinoma (Hep G2) Cells: In vitro and in silico Studies.","authors":"Sahar S Alghamdi, Hussah N Albahlal, Raghad Saleh Alajmi, Amani Alsharidah, Aljawharah Almogren, Rasha Suliman, Zeyad I Alehaideb","doi":"10.2147/BTT.S491278","DOIUrl":"https://doi.org/10.2147/BTT.S491278","url":null,"abstract":"<p><strong>Introduction: </strong><i>Boswellia carteri</i> (<i>B. carteri</i>) resin is widely recognized for its anti-inflammatory, wound-healing, and immunomodulatory properties. This study examines the ability of its aqueous extracts to modulate the expression of key cytochrome P450 (CYP) enzymes-CYP1A2, CYP2B6, and CYP3A4-in Hep G2 cells, emphasizing pharmacokinetic and toxicological implications.</p><p><strong>Methods: </strong>Aqueous extracts were evaluated for endotoxin contamination and cytotoxicity to ensure suitability for in vitro experimentation. PCR analysis was employed to quantify CYP enzyme gene expression. Computational tools, including Protox-II, Swiss ADME, and molecular docking, were used to assess pharmacokinetics, CYP interactions, and biological targets. Competitive binding assays were performed to investigate the involvement of the constitutive androstane receptor (CAR) in CYP induction.</p><p><strong>Results: </strong>The results suggest that several metabolites, particularly ursodeoxycholic acid and beta-sitosterol, show potential interactions with CYP enzymes, with ursodeoxycholic acid demonstrating the highest probability of biological effects on CYP and a strong binding affinity to the Constitutive Androstane Receptor (CAR). Moreover, a receptor competitive binding assay suggested that the primary mechanism of CYP 2B6 and 3A4 induction is through activation of the CAR receptor although additional confirmatory studies are necessary.</p><p><strong>Discussion: </strong>The observed CYP enzyme induction through CAR receptor activation aligns with USFDA guidelines for CYP studies. However, the hepatotoxic potential of ursodeoxycholic acid and the associated toxicity risks of other metabolites underscore the need for caution. The findings highlight the potential for herb-drug interactions, particularly with pharmaceuticals metabolized by CYP enzymes.</p><p><strong>Conclusion: </strong>In conclusion, there is a potential for interactions between <i>B. carteri</i> resins and pharmaceuticals metabolized by CYP enzymes; thus, we advise caution to consumers, patients, and healthcare providers regarding their concomitant use. Although our findings provide valuable insights, further in vivo studies are essential to validate the modulatory effects of <i>B. carteri</i> on CYP gene expression.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"289-320"},"PeriodicalIF":5.3,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12063698/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"OX40/OX40L as a Therapeutic Target in Atopic Dermatitis: A Scoping Review.","authors":"Fernando Valenzuela, Victor Meza","doi":"10.2147/BTT.S511125","DOIUrl":"https://doi.org/10.2147/BTT.S511125","url":null,"abstract":"<p><p>Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease, whose pathophysiology involves a complex interplay of genetic and environmental factors that lead to dysregulated T-cell-mediated inflammatory pathways and a compromised skin barrier. Despite the recent introduction of novel targeted therapies for moderate-to-severe AD, many patients still fail to achieve or maintain treatment goals, or experience treatment-emergent adverse events, which continue to burden their disease management. Recently, the role of T cell co-stimulatory molecule OX40 and its ligand OX40L, which is mainly expressed on professional antigen-presenting cells such as dendritic cells, has attracted widespread research attention as a potential therapeutic target in T cell-mediated skin diseases. Moreover, early basic and clinical research has shown encouraging results regarding the efficacy and safety of therapies targeting the OX40-OX40L axis in moderate-to-severe AD. Therefore, herein we aim to summarize the current evidence regarding the efficacy and safety of inhibiting the OX40/OX40L signaling axis in patients with moderate-to-severe AD.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"281-288"},"PeriodicalIF":5.3,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12054532/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adalimumab Biosimilars Demonstrate Long-Term Durability and Cost-Effectiveness in Paediatric Inflammatory Bowel Disease: A Real-World Two-Centre European Cohort Study.","authors":"Silvana Ancona, Katherine Armstrong, Chiara Longo, Rosalind Rabone, Victoria Merrick, Paul Henderson, Paolo Gandullia, David C Wilson, Serena Arrigo, Richard K Russell","doi":"10.2147/BTT.S511248","DOIUrl":"https://doi.org/10.2147/BTT.S511248","url":null,"abstract":"<p><strong>Purpose: </strong>Adalimumab biosimilars are increasingly used in paediatric Inflammatory Bowel Disease (PIBD), but data remain limited. This study assessed their durability, efficacy, safety and cost implications in PIBD.</p><p><strong>Patients and methods: </strong>Consecutive PIBD patients who started adalimumab biosimilars between October 2018 and December 2023 at two centres in Scotland and Italy, with at least 6 months follow-up, were included. Demographic, disease, treatment, and adverse event data were collected. Disease activity was assessed at baseline, 6, 12, 24, 36 months, and at last follow-up. Durability was evaluated using Kaplan-Meier analysis.</p><p><strong>Results: </strong>In total 130 patients (81 males; median age 12.3 years) were included (115 Crohn's Disease, 7 Ulcerative Colitis, 8 IBD unclassified). The biosimilars were ABP 501 (85%), GP2017 (14%), SB5 (1%); 41 (32%) patients switched from originator. After a median follow-up of 26 months, 87/130 (67%) patients remained on biosimilars, while 43 discontinued at a median of 14 months. Durability probabilities were 93%, 86%, 75%, 62%, and 57% at 6, 12, 24, 36, and 54 months, respectively. Patients previously exposed to ADA originator had a lower risk of biosimilar failure (hazard ratio, adjusted for age at diagnosis: 0.51 [95% confidence interval: 0.26-0.99], p=0.047). Trough levels ≥11.6 μg/mL at 6 months were associated with greater durability (<i>AUC=0.68, p=0.007)</i>. Adverse events occurred in 46/130 patients, mainly psoriasis and injection site reactions (13% each), with one lymphoma. Estimated cost savings were 5,030€ per patient/year.</p><p><strong>Conclusion: </strong>This real-life study demonstrated high durability and remission rates for adalimumab biosimilars in PIBD, confirming their clinical, cost-effectiveness and safety profile in children.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"265-279"},"PeriodicalIF":5.3,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049108/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143963132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Epigenetic Regulation of Sorbitol Dehydrogenase in Diabetic Retinopathy Patients: DNA Methylation, Histone Acetylation and microRNA-320.","authors":"Ramzi Amin, Hikmat Permana, Arief Sjamsulaksan Kartasasmita, Dany Hilmanto, Rachmat Hidayat","doi":"10.2147/BTT.S521519","DOIUrl":"https://doi.org/10.2147/BTT.S521519","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to investigate the correlation between epigenetic markers and sorbitol dehydrogenase (SDH) levels in patients with type 2 diabetes and diabetic retinopathy (DR).</p><p><strong>Patients and methods: </strong>We conducted a case control study on 40 patients with type 2 diabetes and DR and 40 patients with type 2 diabetes without DR. Clinical data and ophthalmological examinations were performed to confirm the presence or absence of DR. Blood samples were collected for the analysis of DNA methylation, histone acetylation, microRNA-320 levels, and SDH enzyme activity. The epigenetic markers were evaluated using enzyme linked immunosorbent modified assay. The data were analyzed using statistical tests, including Spearman correlation and multiple linear regression.</p><p><strong>Results: </strong>In patients with DR, there was a significant negative correlation between microRNA-320 levels and SDH enzyme activity (r=-0.968, p=0.000). No significant correlations were found between DNA methylation or histone acetylation and SDH activity. Multivariate analysis confirmed the strong negative correlation between microRNA-320 and SDH (r = -0.727, p=0.000), with microRNA-320 explaining 58.1% of the variance in SDH levels.</p><p><strong>Conclusion: </strong>The findings suggest that microRNA-320 plays a crucial role in regulating SDH enzyme activity in patients with type 2 diabetes and DR. The development of microRNA-320-based therapies, such as miRNA mimics or antagomirs, may offer a novel approach to modulating SDH activity and mitigating the detrimental effects of the polyol pathway in DR. Further researches are needed to validate the results and mechanism underlying the correlation between epigenetic regulation SDH in DR.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"251-264"},"PeriodicalIF":5.3,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048750/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143967855","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Whole Transcriptome-Based ceRNA Regulatory Network Analysis of Radiation-Induced Esophageal Epithelial Cell Injury.","authors":"Hongyu Lin, Yahui Feng, Hangfeng Liu, Jinkang Zhang, Xiaolin Zhang, Xue Ying, Yuhong Shi, Hao Tan, Wenling Tu","doi":"10.2147/BTT.S496064","DOIUrl":"https://doi.org/10.2147/BTT.S496064","url":null,"abstract":"<p><strong>Introduction: </strong>Esophageal epithelial cells are essential for esophageal homeostasis and defense against harmful stimuli, but the mechanisms of radiation-induced injury in these cells are poorly understood. The competitive endogenous RNA (ceRNA) network, involved in various physiological processes and diseases, may also play a role in radiation-induced injury, although its mechanism remains unclear. This study aimed to investigate the effects of ionizing radiation on human esophageal epithelial cells and explore the role of the ceRNA network in this injury.</p><p><strong>Methods: </strong>Cellular phenotype experiments assessed the effects of ionizing radiation on human esophageal epithelial cells. Whole transcriptome sequencing (lncRNA, circRNA, miRNA, and mRNA) was performed on cells exposed to 0, 2, and 4 Gy radiation. Differentially expressed RNAs (dd-DERs) were identified through differential expression analysis and dose-dependent screening. A ceRNA network was constructed using co-expression analysis and binding site prediction. Real-time quantitative PCR validated the expression levels of selected dd-DERs, and gene set enrichment analysis explored affected pathways.</p><p><strong>Results: </strong>We identified 41 lncRNAs, 18 miRNAs, and 192 mRNAs as dose-dependent differentially expressed RNAs. A ceRNA network comprising 10 lncRNAs, 5 miRNAs, and 55 mRNAs was established. Real-time PCR confirmed the expression levels of 8 dd-DERs within the network. Gene set enrichment analysis showed that radiation disrupted channel activity, cell replication, repair, and immune response. Functional enrichment analysis revealed modulation of metabolic pathways, particularly involving UGT1A family members.</p><p><strong>Discussion: </strong>This study established a ceRNA network related to radiation-induced esophageal epithelial cell injury, advancing our understanding of its pathophysiology. The ceRNA network may mediate injury through metabolic pathway modulation. Future work should focus on elucidating specific ceRNA interactions and exploring therapeutic potential for mitigating radiation-induced esophageal injury.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"231-249"},"PeriodicalIF":5.3,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12034488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Targeted Therapy for Skeletal Muscle Fibrosis: Regulation of Myostatin, TGF-β, MMP, and TIMP to Maintain Extracellular Matrix Homeostasis.","authors":"Nurrani Mustika Dewi, Anna Meiliana, Irma Ruslina Defi, Riezki Amalia, Cynthia Retna Sartika, Andi Wijaya, Melisa Intan Barliana","doi":"10.2147/BTT.S508221","DOIUrl":"https://doi.org/10.2147/BTT.S508221","url":null,"abstract":"<p><p>Muscle fibrosis, defined by the excessive deposition of extracellular matrix (ECM) components, is a key pathological process that hinders muscle regeneration following injury. Despite muscle's inherent regenerative potential, severe or chronic injuries often result in fibrosis, which compromises muscle function and impedes healing. This review explores a range of therapeutic strategies aimed at modulating the molecular pathways involved in muscle fibrosis, with a focus on the inhibition of myostatin and transforming growth factor-β (TGF-β), as well as the regulation of matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs). Some therapy modalities, including physiotherapy and exercise therapy, which are commonly used, have demonstrated the ability to regulate extracellular matrix (ECM) components and promote muscle repair. In addition, the use of TGF-β inhibitors, herbal plants, and other biochemically relevant compounds, holds promise in controlling fibrosis by targeting key signaling pathways that drive ECM accumulation as well as having anti-fibrotic and anti-inflammatory properties. Regenerative medicine, including therapies using stem cell, secretome, and platelet-rich plasma (PRP), have also been used as single or adjuvant treatment for muscle fibrosis, and represents a novel and minimally invasive approach. Although these therapeutic strategies show considerable promise, translating preclinical findings to clinical practice remains challenging owing to variability in patient responses and the complexity of human muscle injuries. In conclusion, a multifaceted approach targeting ECM regulation, either as single treatment or combined treatment, offers a promising avenue for the treatment of muscle fibrosis.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"213-229"},"PeriodicalIF":5.3,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12011048/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143963280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Expression of lncRNA NEAT1, miR-21, and IL17 in Rheumatoid Arthritis Patients.","authors":"Maysa M Haroon, Gehan A Hegazy, Mohammed A Hassanien, Olfat G Shaker, Safa Labib, Wafaa H Hussein","doi":"10.2147/BTT.S519558","DOIUrl":"https://doi.org/10.2147/BTT.S519558","url":null,"abstract":"<p><strong>Background: </strong>Rheumatoid arthritis (RA) is a relatively frequent autoimmune disorder with individual and socioeconomic burden, particularly if diagnosed late. Therefore, identifying novel biomarkers for RA that assist in early diagnosis and managing plan is essential. Long noncoding RNA nuclear paraspeckle assembly transcript 1 (NEAT1), micro-RNA 21 (miR-21) and interleukin 17 (IL17) have emerging roles in the pathogenesis of numerous inflammatory conditions. The present research aims to evaluate NEAT1, miR-21 and IL17 roles in RA manifestations and activity and the possibility of utilizing them as biomarkers or therapeutic targets for the disease. Therefore, expression levels of NEAT1, miR-21 and IL17 in sera of 100 RA cases, and 100 age and sex-matched healthy controls were compared. A subsequent analysis was conducted to examine the correlation of their levels to various RA manifestations and disease activity.</p><p><strong>Results: </strong>Both NEAT1 and IL17 were significantly up regulated, while miR-21 was significantly down regulated in cases compared to controls. NEAT1 demonstrated a significant positive correlation with tender and swollen joint counts and with the overall DAS-28 score. A significant negative correlation was noted between miR-21 and RA disease duration.</p><p><strong>Conclusion: </strong>NEAT1, miR-21, and IL17 have differential levels in patients with RA where NEAT1 and IL17 have up regulation, while miR-21 has down regulation. NEAT1 has a significant correlation with RA disease activity. We recommend further research to determine if they could be useful as future biomarkers for RA.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"201-211"},"PeriodicalIF":5.3,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12009040/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143962031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Antibody-Based Therapeutics in Small Cell Lung Cancer: A Narrative Review.","authors":"Andrea Torchia, Giuliana Ciappina, Maristella Giammaruco, Ilaria Monteferrante, Lorenza Landi, Federico Cappuzzo","doi":"10.2147/BTT.S500460","DOIUrl":"https://doi.org/10.2147/BTT.S500460","url":null,"abstract":"<p><p>Small-cell lung cancer (SCLC) is the most aggressive lung cancer, mostly diagnosed at advanced stage, and with few therapeutic options for patients failing the first-line treatment. Antibody-based therapies, such as antibody-drug conjugates and T-cell engagers, are emerging as a promising option in the treatment of various solid tumors, including SCLC. T-cell engagers are molecules able to trigger the T-cell-mediated tumor cell death binding, at the same time, a T-cell and a tumor cell target. Tarlatamab is a DLL3-directed bi-specific T-cell engager (BiTE) whose efficacy was evaluated in a Phase 2 study. Antibody-drug conjugates (ADC) consist of a tumor-directed monoclonal antibody conjugated to a cytotoxic payload able to selectively kill tumor cells through different mechanisms. Ifinatamab-deruxtecan is an anti-B7-H3 ADC showing efficacy in pretreated SCLC patients in a phase 2 clinical trial. Sacituzumab govitecan is a Trop-2-directed ADC already used in other tumor types and evaluated in SCLC in the phase 2 TROPiCS-03 trial, with positive results. Bispecific antibodies targeting VEGF and PD-(L)1 showed antitumor activity in phase 1 and 2 clinical trials. Other antibody-based agents are currently at an earlier phase of their clinical development and showed a promising activity. Novel antibody-based agents could potentially acquire a prominent role in the treatment of SCLC, a field with few therapeutic options. Direct comparisons with the current standard of care still lack, however Phase 3 trials are currently ongoing.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"189-199"},"PeriodicalIF":5.3,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12009746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing Monoclonal Antibody Manufacturing: Process Optimization, Cost Reduction Strategies, and Emerging Technologies.","authors":"Ranjit Ranbhor","doi":"10.2147/BTT.S515078","DOIUrl":"https://doi.org/10.2147/BTT.S515078","url":null,"abstract":"<p><strong>Purpose: </strong>This review examines recent advances in monoclonal antibody (mAb) manufacturing, focusing on process optimization, cost reduction strategies, and emerging technologies. The analysis addresses critical challenges in current manufacturing processes while evaluating innovative solutions to improve production efficiency and economic viability.</p><p><strong>Methods: </strong>We conducted a comprehensive analysis of recent literature on mAb manufacturing, examining traditional batch processing, continuous processing, and hybrid systems. The review evaluates cost optimization strategies, including media development and process integration, while assessing the impact of emerging technologies, such as machine learning and advanced analytics, on manufacturing efficiency.</p><p><strong>Results: </strong>Recent studies demonstrate that continuous processing can achieve up to 35% cost savings compared to traditional batch processing to meet an annual production demand of 100-500 kg, though this gain diminishes at larger scales. Hybrid facilities show accelerated break-even points, reaching profitability 2-2.5 years earlier than traditional facilities. Advanced media optimization strategies, incorporating novel tripeptide delivery methods, have demonstrated up to 35% improvement in mAb titers. Integration of machine learning and advanced analytics has significantly enhanced process control and optimization capabilities.</p><p><strong>Conclusion: </strong>The evolution of mAb manufacturing technologies offers promising pathways for improving production efficiency and reducing costs. Scale-dependent considerations remain crucial in selecting optimal manufacturing strategies, while emerging technologies present new opportunities for process optimization. Future developments in continuous processing, advanced analytics, and cell line engineering will be essential in meeting growing global demand while ensuring economic viability and accessibility of mAb therapeutics.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"19 ","pages":"177-187"},"PeriodicalIF":5.3,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11994081/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}