Journal of pharmaceutical and biomedical analysis最新文献

{"title":"Joint multi-technology applications for etablishing quality evaluation model of Coptidis Rhizoma","authors":"Mengyuan Li ,&nbsp;Jinling Guo ,&nbsp;Yuanhao Zhang ,&nbsp;Jingwen Yao ,&nbsp;Jiaming Ge ,&nbsp;Chenlu Wu ,&nbsp;Jing Zhao ,&nbsp;Ming Liu","doi":"10.1016/j.jpba.2025.116952","DOIUrl":"10.1016/j.jpba.2025.116952","url":null,"abstract":"<div><div>Based on the pharmacodynamic components of Coptidis Rhizoma (CR) against oral squamous cell carcinoma (OSCC), the combination of chromatographic and spectroscopic techniques was used to achieve the rapid detection of CR quality, which provided a reference for the implementation of the quality detection method of CR oriented to the clinical efficacy. Firstly, the pharmacodynamic components of CR in the treatment of OSCC were studied by means of network pharmacology and molecular docking technology, and the pharmacodynamic components were screened and verified in vitro to screen out the key active components. Subsequently, the contents of key active ingredients of CR from different origins were detected and quantitative analysis models were established by a combination of high performance liquid chromatography (HPLC) and near infrared spectroscopy (NIR) techniques. The results showed that berberine and palmatine in CR had strong curative effect in the treatment of OSCC. Using berberine and palmatine as the key active ingredients, the content of the key active ingredients obtained by HPLC was used as the reference, and the prediction model of berberine and palmatine content was constructed by combining the NIR and partial least squares regression algorithm, and the model obtained a better prediction result with the correlation coefficients of R²_p of 0.9704 and 0.8793, respectively. This study screened the index components of CR against OSCC, and also demonstrated that NIR combined with chemometrics had the ability to quantitatively analyse the content of the components quickly, conveniently and accurately. This study is expected to be used for the simultaneous rapid detection of the anti-OSCC components in CR, which will provide a reference for the quality evaluation of CR raw herbs oriented to clinical efficacy.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"264 ","pages":"Article 116952"},"PeriodicalIF":3.1,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144071146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comprehensive study of degradation pathways and formation mechanism of major degradation impurities of gamithromycin active ingredient by UHPLC-HRMS and NMR","authors":"Nayanthara U. Dharmaratne,&nbsp;Abu M. Rustum","doi":"10.1016/j.jpba.2025.116969","DOIUrl":"10.1016/j.jpba.2025.116969","url":null,"abstract":"<div><div>Gamithromycin is a semi-synthetic antibacterial agent used for treating cattle bovine respiratory disease. This study was performed focusing on separating and identifying the degradation impurities of gamithromycin while elucidating its degradation mechanisms. A comprehensive forced degradation analysis was meticulously conducted on the gamithromycin drug substance following VICH/ICH guidelines under a range of stress conditions, including acid, base, oxidation (using H₂O₂ and K₂Cr₂O₇), thermal, and photolytic stress. The analytes were separated by ultra-high performance liquid chromatography using a gradient elution on an Agilent Poroshell HPH-C18 column (50 mm × 2.1 mm, 1.9 µm) at a temperature of 60 °C. The mobile phases employed were 10 mM aqueous NH₄HCO₃ as mobile phase-A and a mixture of acetonitrile and methanol (7:3, v/v) as mobile phase-B. This study identified six degradation and five additional process impurities in the gamithromycin drug substance using high-resolution mass spectrometry in conjunction with tandem mass spectrometry. For impurity 6, an additional investigation was performed using nuclear magnetic resonance spectroscopy to confirm its structure. Mechanisms for the formation of the degradation impurities were also proposed. These findings enhance the understanding of the stability characteristics of gamithromycin and would provide significant insights for the formulation of drug products that include this drug.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"264 ","pages":"Article 116969"},"PeriodicalIF":3.1,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144154424","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Metabolomics uncovers Rubus idaeus-mediated recovery of energy and arginine metabolism in liver injury","authors":"Yudan Xu ,&nbsp;Lei Zhang ,&nbsp;Tengteng Fu ,&nbsp;Xujin Yang,&nbsp;Enna Lan,&nbsp;Yuling Deng,&nbsp;Yi Tao","doi":"10.1016/j.jpba.2025.116955","DOIUrl":"10.1016/j.jpba.2025.116955","url":null,"abstract":"<div><div>The global incidence of acute liver injury continues to rise, posing a significant threat to public health. While both raw and processed <em>Rubus idaeus</em> Linnaeus (RI) demonstrate hepatoprotective properties, their mechanisms require further elucidation. This study employed UPLC-Q-TOF/MS-based serum metabolomics to delineate the distinct liver-protective mechanisms of raw and processed RI in a murine model of acute liver injury. Following ten days of intragastric administration with low, medium, and high doses of raw and processed RI extracts, mice received intraperitoneal injection of 50 % carbon tetrachloride in olive oil. Serum levels of aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP), as well as liver levels of superoxide dismutase (SOD), malondialdehyde (MDA), and hydroxyproline (Hyp), were measured via ELISA. Liver histopathology was examined using Hematoxylin and Eosin (HE), Masson, and Sirius Red staining. Treatment with both raw and processed RI significantly reduced serum AST, ALT, and ALP levels while decreasing hepatic MDA and Hyp content compared to the model group. Conversely, SOD activity showed marked elevation. Metabolomic profiling identified 39 significantly altered endogenous metabolites in the model group, with subsequent characterization of 22, 23, and 7 distinctive biomarkers in the raw, salt-processed, and wine-processed RI treatment groups, respectively. These biomarkers predominantly associated with energy metabolism and arginine metabolism. Furthermore, the phenolic and flavonoid compounds in RI, known for their anti-inflammatory and antioxidant properties, played a key role in mitigating liver damage induced by CCl₄. These findings provide strong evidence supporting the potential use of both raw and processed RI in the development of hepatoprotective health products.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"264 ","pages":"Article 116955"},"PeriodicalIF":3.1,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144068048","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Functional metabolomics revealed pyroglutamic acid may play a key role in idiopathic pulmonary fibrosis","authors":"Yang Wen,&nbsp;Jia-hui Nie,&nbsp;Xue-mei Qin,&nbsp;Zhen-yu Li","doi":"10.1016/j.jpba.2025.116967","DOIUrl":"10.1016/j.jpba.2025.116967","url":null,"abstract":"<div><div>Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, and irreversible respiratory disease with poor survival rates. Despite significant research efforts, IPF still lacks a curative treatment. Excessive epithelial-mesenchymal transition (EMT) contributes to approximately one-third of fibroblasts in pulmonary fibrosis and plays a critical role in IPF pathogenesis. Identifying factors that regulate EMT is essential for developing effective therapeutic strategies for IPF. In this study, functional metabolomics revealed significant alterations in multiple metabolites in transforming growth factor-beta 1 (TGF-β1)-induced A549 cells, with pyroglutamic acid and 5-oxoprolinase (OPLAH) being identified as the most critical factors. Cellular experiments demonstrated that pyroglutamic acid effectively inhibited TGF-β1-induced EMT in A549 cells. Mechanistically, pyroglutamic acid inhibited IPF by suppressing EMT through the inhibition of Smad2/3 expression in TGF-β1-induced A549 cells. Bioinformatics analysis further elucidated the pyroglutamate is a potential metabolite that inhibits EMT. In addition, this study is the first to highlight the pivotal role of pyroglutamic acid and OPLAH in regulating EMT in IPF, offering novel insights into the metabolic mechanisms involved in IPF inhibition and providing a foundation for developing innovative therapeutic approaches for IPF.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"264 ","pages":"Article 116967"},"PeriodicalIF":3.1,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144088641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Proteomic study of plasma and L1CAM-captured exosomal proteins in children with autism spectrum disorders","authors":"Huajie Zhang ,&nbsp;Zhiyuan Liang ,&nbsp;Hongbin Zhuang ,&nbsp;Mingxian Wang ,&nbsp;Yuhan Huang ,&nbsp;Xueshan Cao ,&nbsp;Haiyi Chen ,&nbsp;Liming Shen ,&nbsp;Chengyun Feng","doi":"10.1016/j.jpba.2025.116965","DOIUrl":"10.1016/j.jpba.2025.116965","url":null,"abstract":"<div><div>Autism spectrum disorder (ASD) has become a neurodevelopmental disorder that seriously endangers the health of infants and children. In order to explore the pathogenesis of the disease and search for early diagnostic biomarkers. In this study, plasma exosomes (PEs) and neural cell adhesion molecule L1 (L1CAM)-captured exosomes (LCEs) of ASD and controls were extracted and lysed to obtain proteins. Isobaric tags for relative and absolute quantitation (iTRAQ) proteomics were applied to investigate the differences in the expression of PEs and LCEs proteins between the two groups. Twenty-eight plasma exosomal differentially expressed proteins (DEPs) were identified, which were mainly associated with immunity, inflammation, complement and coagulation, and lipoprotein metabolism and transport. Twenty L1CAM-captured exosomal DEPs were identified, which were mainly involved in cytoskeleton, tight junctions, focal adhesion, and platelet-associated pathways. Meanwhile, our results suggested that processes or signaling pathways associated with the DEPs from plasma exosomes may be activated, whereas those associated with L1CAM-captured exosome may be inhibited. These processes or signaling pathways have been reported to be associated with ASD in previous studies. These DEPs have the potential to be diagnostic markers. This study provides new insights into disease mechanisms and diagnostic markers of ASD.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"264 ","pages":"Article 116965"},"PeriodicalIF":3.1,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144088640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"LBA and LC-MS/MS based comprehensive bioanalytical methods for FDA018, a Trop-2 targeted antibody-drug conjugate","authors":"Minlu Cheng ,&nbsp;Xianjing Li ,&nbsp;Ya Li ,&nbsp;Yiya Wang ,&nbsp;Wenjia Li ,&nbsp;Shuai Wang ,&nbsp;Chang Shu ,&nbsp;Qinxin Song ,&nbsp;Li Ding","doi":"10.1016/j.jpba.2025.116964","DOIUrl":"10.1016/j.jpba.2025.116964","url":null,"abstract":"<div><div>Recently, the approval of Trop-2 targeted antibody drug conjugate (ADC) has changed the dilemma of patients with advanced triple-negative breast cancer who rely on chemotherapeutics to improve their survival. FDA018, an ADC consisting of an anti-Trop-2 antibody conjugated with a topoisomerase inhibitor SN-38 via an acid-cleavable linker, is currently being investigated in clinical trials. Based on the urgent demand to evaluate the clinical pharmacokinetics of FDA018, ligand binding assays (LBAs) for the determination of SN-38-conjugated antibody and total antibody and LC-MS/MS methods for the determination of the free SN-38, its metabolite SN-38G and total SN-38 were developed. The comparability and DAR sensitivity evaluation of the ELISA strategies for SN-38-conjugated antibody and total antibody were emphasized. The sensitivity of the LC-MS/MS method for the simultaneous determination of SN-38 and SN-38G reached 0.500 ng/mL and 0.250 ng/mL, respectively. An effective solution has been proposed for the optical instability of the cleavable linker of FDA018 during the pretreatment process of biological samples. The established bioanalytical methods were comprehensively validated and the results satisfied the acceptable criteria of ICH M10. The validated bioanalytical methods have been applied to the single-dose pharmacokinetic study of FDA018 in patients with Trop-2-positive malignant tumors successfully, and the pharmacokinetic profiles of FDA018 and its constituent components were investigated.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"264 ","pages":"Article 116964"},"PeriodicalIF":3.1,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143948543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Smoking of Gentiana lutea leaves: Validation of its traditional use","authors":"Teodora Janković ,&nbsp;Jelena Mudrić ,&nbsp;Vesna Radojičić ,&nbsp;Lazar Pejić ,&nbsp;Nada Ćujić Nikolić ,&nbsp;Smilja Marković ,&nbsp;Nebojša Menković","doi":"10.1016/j.jpba.2025.116968","DOIUrl":"10.1016/j.jpba.2025.116968","url":null,"abstract":"<div><div>The roots and rhizomes of <em>Gentiana lutea</em> L. are officially listed in the European Pharmacopeia and numerous national pharmacopeias and are used mainly to treat gastrointestinal disorders. In contrast, the leaves are traditionally smoked for the treatment of angina pectoris, but scientific support and justification for its traditional use are missing. Therefore, the chemical composition and gentian leaves before and after smoking were investigated in this study. A standardized smoking machine was used to generate cigarette smoke and the chemical constituents were analyzed by high-performance liquid chromatography (HPLC). The analysis showed that a significant proportion (68.77 %) of the xanthone isogentisin was transferred intact from the leaves to the smoke stream, making it the only compound detected in the smoke condensate. Thermogravimetric analysis revealed that isogentisin underwent thermal decomposition within the temperature range of 250–448 °C. These findings provide scientific evidence supporting the medicinal potential of gentian leaves, with isogentisin identified as the active constituent. Furthermore, the thermal stability profile of isogentisin offers valuable insights into its behavior during combustion.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"264 ","pages":"Article 116968"},"PeriodicalIF":3.1,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144068057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lipidomic profiling reveals the dynamic changes of hepatic lipidome during the fasting-refeeding transition in mice","authors":"Xuan Li ,&nbsp;Yue Gao ,&nbsp;Shicheng Fan ,&nbsp;Jie Yang ,&nbsp;Yifei Zhang ,&nbsp;Xiao Yang ,&nbsp;Chenghui Cai ,&nbsp;Min Huang ,&nbsp;Huichang Bi","doi":"10.1016/j.jpba.2025.116966","DOIUrl":"10.1016/j.jpba.2025.116966","url":null,"abstract":"<div><div>Liver plays a pivotal role in maintaining energy homeostasis during fasting-refeeding transition. We previously reported that fasting-refeeding induces the dynamic changes of liver size. However, the alterations in hepatic lipid profiles during these dynamic changes remain unclear. Therefore, the present study aimed to clarify the effect of fasting and refeeding on hepatic lipid homeostasis in mice using lipidomics analysis and to identify the specific lipids that vary during the fasting-refeeding transition. In this study, C57BL/6 mice were fasted for 24 h and subsequently refed for 1, 3, 6, 12, and 24 h, respectively. Liver and serum samples were collected at each time point for further analysis. The results demonstrated that fasting obviously decreased the liver size accompanying with hepatic lipid accumulation, which were all returned to normal level after refeeding. Lipidomics analysis revealed that a total of 309 lipids were significantly disturbed, over half of them belonged to triacylglycerol (TG). Consistently, fasting significantly altered the expression of genes associated with fatty acid uptake, TG synthesis and metabolism, which were returned to baseline level after refeeding. In conclusion, these findings demonstrated that fasting induced liver shrinkage and the change of lipid profiling, especially TG accumulation in liver, while these effects can be reversed after refeeding.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"264 ","pages":"Article 116966"},"PeriodicalIF":3.1,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144071147","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Surrogate matrix approach to quantify endogenous progesterone in a fasting bioequivalence study of soft gelatin capsules in postmenopausal women","authors":"Gopal Prasad Agrawal ,&nbsp;Kanchan Soni ,&nbsp;Perwez Alam ,&nbsp;Sudipta Basu ,&nbsp;Mohammed Faiz Arshad","doi":"10.1016/j.jpba.2025.116960","DOIUrl":"10.1016/j.jpba.2025.116960","url":null,"abstract":"<div><div>In the present study, endogenous progesterone in plasma was quantified using a validated LC–MS/MS method. This bioanalytical technique was successfully applied to a bioequivalence study in postmenopausal female volunteers. The assay achieved a lower limit of quantification (LLOQ) of 20 pg/mL for endogenous progesterone. Electrospray ionization in positive mode was coupled to a triple-quadrupole mass spectrometer, with deuterated progesterone (progesterone-D9) as the internal standard. Chromatographic separation was performed on a Kinetex Biphenyl column (100 × 4.6 mm, 5 μm) using a time- and flow-gradient program to ensure symmetrical peak shapes and complete resolution from potential interferences. Progesterone was extracted from plasma using methyl tert-butyl ether, affording high recovery and negligible matrix effects. Quantitation was carried out in multiple-reaction monitoring (MRM) mode, monitoring the transitions <em>m/z</em> 315.5 → 97.2 for progesterone and <em>m/z</em> 324.3 → 113.1 for progesterone-D9. The calibration curve was linear over the range of 20.0–40 000.0 pg/mL and was fitted by weighted (1/x²) linear regression. The method fully complies with current regulatory guidelines for bioanalytical assay validation.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"264 ","pages":"Article 116960"},"PeriodicalIF":3.1,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143948542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding the clearance behaviour of elemental leachables during ultrafiltration/diafiltration from process streams","authors":"Noemí Dorival-García ,&nbsp;Anna Mulligan ,&nbsp;Ronan Hayes ,&nbsp;Charles Felice ,&nbsp;Aidan Sexton ,&nbsp;Ping-Ping Wang ,&nbsp;Jonathan Bones","doi":"10.1016/j.jpba.2025.116963","DOIUrl":"10.1016/j.jpba.2025.116963","url":null,"abstract":"<div><div>The introduction of trace elemental impurities through the use of single use technologies (SUTs) during biopharmaceutical manufacturing is a key concern as the presence of process equipment related leachables (PERLs) such as process related elemental impurities has potential harmful implications on product quality and patient safety. ICH Q3A provides a regulatory road map for PERLs but excludes biologic drugs like monoclonal antibody (mAb) therapies. Consequently, the industry lacks a synchronized, risk-based testing strategy for PERLs based on the likelihood of their presence in the final drug product. Ultrafiltration and diafiltration (UF/DF) operations have been demonstrated to clear leachables from the drug product during downstream purification. Hence, it is attractive to characterize PERL behavior during UF/DF to inform subsequent extractable and leachable (E&amp;L) evaluation of the formulated biologic. The reduction capacity of twenty-two elements spiked into concentrated protein samples during UF/DF processes was investigated, using an inductively coupled plasma-mass spectrometry (ICP-MS) method, which was developed and validated according to ICH Q2 (R1) guidelines. Most elements (18) were efficiently cleared (&gt;97 %), representing a 100-fold (2-log) reduction or higher after 10 diavolumes. Clearance was linked to UF/DF process parameters, most notably pH, as well as to the physicochemical properties of the studied elements. Mathematical models based on Orthogonal Partial Least Squares (OPLS) regression were developed and validated using the sieving coefficient to characterize and predict the clearance behavior of elemental impurities during UF/DF. Results from this study lay a solid foundation for the understanding and prediction of UF/DF capacity to remove elemental leachables. PERL clearance modelling emerges as a valuable platform to support industry and regulatory bodies in developing sophisticated risk-based PERL testing strategies, ultimately ensuring patient safety. The data presented herein demonstrate the significant risk reduction that the UF/DF process provides for processing steps upstream in mAbs and other biologics processes.</div></div>","PeriodicalId":16685,"journal":{"name":"Journal of pharmaceutical and biomedical analysis","volume":"264 ","pages":"Article 116963"},"PeriodicalIF":3.1,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144071144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}