BioanalysisPub Date : 2024-10-16DOI: 10.1080/17576180.2024.2412438
Derek J Maloney, Jianying Zhang, Satyaj Bhargava, MaCalus V Hogan, James H-C Wang
{"title":"Quantifying skin permeation of a novel metformin lotion using modified hydrophilic interaction liquid chromatography.","authors":"Derek J Maloney, Jianying Zhang, Satyaj Bhargava, MaCalus V Hogan, James H-C Wang","doi":"10.1080/17576180.2024.2412438","DOIUrl":"https://doi.org/10.1080/17576180.2024.2412438","url":null,"abstract":"<p><p><b>Aim:</b> This study aimed to quantify the permeation of metformin (Met) lotion through pig ear skin using high-performance liquid chromatography, specifically hydrophilic interaction liquid chromatography (HILIC), to separate Met from biological contaminants and effectively measure its permeation through skin similar to human skin.<b>Materials & methods:</b> A Franz cell permeation assay was used to assess the permeation kinetics of 6% Met lotion through pig ear skin. Samples were collected at various time points and prepared for high-performance liquid chromatography analysis by removing large biological contaminants. The permeated Met was quantified by monitoring its retention time (RT) at 9 min using HILIC, with an acidic, polar mobile phase and a normal-phase column.<b>Results:</b> A distinct Met peak with a RT of approximately 9 min was observed in the 6% Met lotion, which was absent in the permeation samples from the 0% Met lotion. This peak (RT 9 min) was distinct from the 'biological-contaminants' peaks at RT 2-3 min and increased linearly over time, reaching 36.8% of the total applied Met at 24 h.<b>Conclusion:</b> These findings demonstrate that the HILIC method effectively separates Met from biological components in pig ear skin, allowing accurate quantification of Met despite the presence of skin lipids and proteins.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142457045","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}
BioanalysisPub Date : 2024-10-15DOI: 10.1080/17576180.2024.2407718
Achani M Silva, Elizabeth S Hickford, Paul Cutler
{"title":"An immunoassay for the quantification of phosphorylated α-synuclein at serine 129 in human cerebrospinal fluid.","authors":"Achani M Silva, Elizabeth S Hickford, Paul Cutler","doi":"10.1080/17576180.2024.2407718","DOIUrl":"https://doi.org/10.1080/17576180.2024.2407718","url":null,"abstract":"<p><p>The link between alpha Synuclein (α-Syn) phosphorylation and Parkinson's disease pathogenesis has not been fully elucidated, in part due to analytical methods with finite specificity and sensitivity, resulting in conflicting data on pathophysiological levels of the protein.One factor hindering the assessment of the role of pSer129 α-Syn is the lack of a fit for purpose assay. Antibodies were assessed for quantification of pSer129 α-Syn, resulting in a sensitive and specific assay suitable for use in Parkinson's disease and control CSF, with no significant difference found between the two populations. Total α-Syn was measured using a commercial kit, demonstrating a positive correlation between total and pSer129 α-Syn.This adds to available methods for pSer129 α-Syn in support of α-synucleinopathy research.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142457041","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}
BioanalysisPub Date : 2024-10-10DOI: 10.1080/17576180.2024.2403241
Patrick Schreier, Lili Huang, Emma Fung, Jennifer Mollon, Bernhard Sielaff, Marc R Lake, Michael Schulz, Khader Awwad
{"title":"Development and validation of an ultra-performance liquid chromatography with tandem mass spectrometry method for determination of soluble repulsive guidance molecule A in human serum and cerebrospinal fluid.","authors":"Patrick Schreier, Lili Huang, Emma Fung, Jennifer Mollon, Bernhard Sielaff, Marc R Lake, Michael Schulz, Khader Awwad","doi":"10.1080/17576180.2024.2403241","DOIUrl":"https://doi.org/10.1080/17576180.2024.2403241","url":null,"abstract":"<p><p><b>Aim:</b> Repulsive guidance molecule A (RGMa) is upregulated in neurodegenerative diseases. To assess RGMa levels in human serum and cerebrospinal fluid (CSF), a quantification method was developed and validated according to ICH M10 guideline.<b>Methods & results:</b> Sample preparation consisted of immunoprecipitation (IP, only for serum), digestion and purification followed by MS.<b>Conclusion:</b> An UPLC-MS/MS method was established and used to assess normal range of soluble RGMa levels in serum and CSF of healthy controls, and patients with mild cognitive impairment or Alzheimer's disease. The normal range was between 13.0-44.8 ng/ml (CSF) and 9.9-20.9 ng/ml (serum) in healthy controls. In the CSF of patients with mild cognitive impairment and Alzheimer's disease, total soluble RGMa was twofold lower while unchanged in serum.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142457042","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}
BioanalysisPub Date : 2024-10-08DOI: 10.1080/17576180.2024.2407228
Fengying Zhu, Ya-Ping Tu, Callum Sloss, Yuemei Wang
{"title":"Assessment of mirvetuximab soravtansine immunogenicity in patients with folate receptor alpha-positive ovarian cancer.","authors":"Fengying Zhu, Ya-Ping Tu, Callum Sloss, Yuemei Wang","doi":"10.1080/17576180.2024.2407228","DOIUrl":"https://doi.org/10.1080/17576180.2024.2407228","url":null,"abstract":"<p><p><b>Aim:</b> The aim of this research was to evaluate the immunogenicity of mirvetuximab soravtansine (MIRV), an antibody-drug conjugate in patients with folate receptor alpha-positive ovarian cancer across four clinical studies.<b>Materials & methods:</b> An assay was developed and validated for the detection of antidrug antibodies (ADAs) against MIRV. A cell-based method was also developed and validated for the detection of neutralizing anti-MIRV antibodies (NAbs). Both ADAs and NAbs were assessed across four clinical studies in 734 patients.<b>Results:</b> Across studies, MIRV demonstrated low immunogenicity with 7.8% of patients with treatment-emergent ADAs, 7.2% with treatment-unaffected ADAs, and 0.5% with treatment-enhanced ADAs. MIRV trough concentrations were comparable in ADA-negative and ADA-positive individuals. Limited data suggest that MIRV ADAs may be associated with decreased efficacy. Due to the very limited number of NAb-positive individuals, no conclusions could be drawn on the effect of NAb on efficacy.<b>Conclusion:</b> Both the validation tests and the data from the MIRV clinical studies demonstrated that these assays were suitable and reliable for the detection of MIRV ADAs and NAbs. These validated assays will continue to be used to monitor MIRV immunogenicity in future clinical trials.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142387594","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}
BioanalysisPub Date : 2024-10-07DOI: 10.1080/17576180.2024.2404311
Tiantao Gao, Xiaoxue Ou, Jia Miao, Yongping Qin
{"title":"Quantification of MDR-TB drug JBD0131 and its metabolite in plasma via UPLC-MS/MS: application in first-in-human study.","authors":"Tiantao Gao, Xiaoxue Ou, Jia Miao, Yongping Qin","doi":"10.1080/17576180.2024.2404311","DOIUrl":"https://doi.org/10.1080/17576180.2024.2404311","url":null,"abstract":"<p><p><b>Aim:</b> JBD0131, a novel anti-multidrug-resistant tuberculosis (MDR-TB) drug, can target and inhibit the synthesis of mycolic acids, which are crucial components of the cell wall of the <i>Mycobacterium tuberculosis</i> complex. To support the results of this clinical trial in healthy subjects, development of a specific and accurate quantification method for detecting JBD0131 and its metabolite DM131 in human plasma is needed.<b>Materials & methods:</b> Samples with prior added stabilizer were pretreated by protein precipitation method and the extracts were subjected to ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS). The m/z transitions for the precursor/product ion pairs were 402.1/273 for JBD0131, 333.1/273 for DM131 and 386.1/257 for the internal standard (IS).<b>Results:</b> This method showed good linearity from 1 to 2000 ng/ml for JBD0131 and 0.25 to 500 ng/ml for DM131 and was validated in terms of selectivity, linearity, accuracy, precision, matrix effect, recovery of pretreament and stability.<b>Conclusion:</b> This method was sensitive and specific for measuring the plasma concentrations of JBD0131 and its metabolites. And it was applied for the investigation of the pharmacokinetics of JBD0131 and DM131 in a clinical trial.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380021","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}
BioanalysisPub Date : 2024-09-27DOI: 10.1080/17576180.2024.2404383
Mariana Smidt, Marcos Frank Bastiani, Roberta Zilles Hahn, Lilian de Lima Feltraco Lizot, Amanda Pacheco Bondan, Giovana Piva Peteffi, Náthaly Cbf Dos Santos, José Luiz da Costa, Rafael Lanaro, Rafael Linden
{"title":"Determination of drugs of abuse and metabolites in plasma microsamples by LC-MS/MS after microQuEChERS extraction.","authors":"Mariana Smidt, Marcos Frank Bastiani, Roberta Zilles Hahn, Lilian de Lima Feltraco Lizot, Amanda Pacheco Bondan, Giovana Piva Peteffi, Náthaly Cbf Dos Santos, José Luiz da Costa, Rafael Lanaro, Rafael Linden","doi":"10.1080/17576180.2024.2404383","DOIUrl":"https://doi.org/10.1080/17576180.2024.2404383","url":null,"abstract":"<p><p><b>Aim:</b> Identifying drugs of abuse and their metabolites in plasma is vital in both forensic and clinical toxicology. While the QuEChERS (Quick, Easy, Cheap, Effective, Rugged and Safe) method offers an efficient approach to sample preparation, its application is complex due to the wide-ranging properties of target analytes and the challenges posed by biological matrix interferences. This study aims to develop a microQuEChERS approach for the quantification of 14 drugs of abuse and metabolites utilizing minimal sample and solvent volumes.<b>Methods:</b> The microQuEChERS method involved using 10 μl plasma samples, 25 mg of a salt mixture and 150 μl of acetonitrile. Extracts were analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS), with a 7.5 min run. The assay was validated according to bioanalytical guidelines.<b>Results:</b> The accuracy was 96.8-112.4%. The within-assay precision was within 2.0-8.9% and the between-assay precision was within 3.2-8.2%. Matrix effects were found to range from -5.7 to 13.5%. The extraction yield was higher than 74.7%.<b>Conclusion:</b> This study described a microQuEChERS sample preparation approach for determining drugs of abuse and metabolites using plasma microsamples and LC-MS/MS. The approach is efficient, environmentally friendly and suitable for scenarios with limited amounts of biological samples.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142340405","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}
BioanalysisPub Date : 2024-09-25DOI: 10.1080/17576180.2024.2403206
Prapha Arnnok, Rodjana Burakham
{"title":"Multi-residue analysis method based on QuEChERS followed by ultra-high performance liquid chromatography coupled with diode-array detector for pesticides in human serum and breast milk.","authors":"Prapha Arnnok, Rodjana Burakham","doi":"10.1080/17576180.2024.2403206","DOIUrl":"https://doi.org/10.1080/17576180.2024.2403206","url":null,"abstract":"<p><p><b>Background:</b> Maternal fluids play a key role in the risk assessment regarding early life pesticide exposure as the chemicals can transfer to neonate through prenatal exposure and lactation.<b>Aim:</b> A developed UHPLC-DAD and modified QuChERS methods were validated for human serum and breast milk. Matrix effect of the biological samples were evaluated.<b>Methods & results:</b> Serum was extracted by unbuffered QuChERS method while breast milk was extracted by citrate buffered method with addition of hexane. Remaining lipid in breast milk extract was later removed using lipid-removal sorbent. Sample matrices caused huge impacted on low-sensitivity pesticides.<b>Conclusion:</b> The modified QuEChERS methods coupled with UHPLC-DAD were fully validated. Application in paired-serum and breast milk samples revealed 6 detected pesticides.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142340406","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":"High-performance liquid chromatography-tandem mass spectrometry was used to measure 20 antidepressants in human serum.","authors":"Huanchang Luo, Jianwei Zhou, Guanfeng Lin, Xiaojing Huang, Yuhang Yang, Yingsong Wu","doi":"10.1080/17576180.2024.2401283","DOIUrl":"10.1080/17576180.2024.2401283","url":null,"abstract":"<p><p><b>Aim:</b> This study used high performance liquid chromatography-tandem mass spectrometry to quantify the blood concentrations of 20 antidepressants, such as bupropion and fluoxetine, in human serum samples.<b>Methods:</b> After direct precipitation with a 1:9 protein precipitant of methanol and acetonitrile, serum samples were examined using high-performance liquid chromatography-tandem mass spectrometry (UPLC-MS). The material was separated using a Poroshell 120 EC-C18 column (3.0 mm × 50 mm, 2.7 μm) and gradient elution. The mobile phases were phase A 0.01% formic acid aqueous solution (containing 2 mmol/ml ammonium acetate) and phase B methanol solution. A 0.45 ml/min flow rate was used to divide the sample and inject 5 μl. Electrospray ionization source positive ion mode and multiple reaction monitoring modes were used for analysis. Measurement was quantified using an internal standard technique.<b>Results:</b> Accuracy ranged from 90.3 to 114.3%, intra-day precision from 100.1 to 112.3%, inter-day precision from 100.4 to 112.6%, extraction recoveries from 85.5 to 114.5% and matrix effect from 85.6 to 98.7%.<b>Conclusion:</b> This approach is fast, accurate, sensitive and repeatable. It can identify 20 antidepressants in blood simultaneously. This can be used to monitor blood drug levels and medication metabolism.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142307035","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":"Highlights of the 15th Japan Bioanalysis Forum Symposium.","authors":"Makoto Niwa, Tomoko Arakawa, Koji Arai, Noriyuki Koyama, Hisanori Hara, Katsutomo Hata, Masayo Hashimoto, Eiichi Shimada, Hiroyuki Shimizu, Yuki Takamatsu, Hitoshi Uchiyama, Takeru Yamaguchi, Kenichi Yamamoto, Masaaki Kakehi, Yuu Moriya, Hironosuke Kurisu, Hisao Nagaya, Tsunenori Nakazawa, Shohei Noguchi, Yuki Oda, Hiromi Okamoto, Shinsuke Uchihashi","doi":"10.1080/17576180.2024.2395715","DOIUrl":"https://doi.org/10.1080/17576180.2024.2395715","url":null,"abstract":"<p><p>The 15th Japan Bioanalysis Forum (JBF) Symposium was held in Kyoto, Japan, between 5 and 7 February 2024. The conference theme, 'Toward the new world - Science as a universal endeavor' indicated that universal discussion based on science is making a basis of regulatory and analytical sciences, now internationally harmonized. The symposium discussed a wide range of topics, including ICH M10, quantitative PCR, immunogenicity, peptide LC-MS, e-notebooks, artificial intelligence, reliability standards, carrier development, inviting domestic and overseas experts. Approximately 360 attendees from various fields, including pharmaceutical companies, contract research organizations, academia and regulators, gathered in person or online.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279974","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":"Interference from anti-drug antibodies on the quantification of insulin: a comparison of an LC-MS/MS assay and immunoassays.","authors":"Georgina Marta Varga, Manca Spendal, Jens Sigh, Tue Søeborg, Nikoline Juul Nielsen","doi":"10.1080/17576180.2024.2389637","DOIUrl":"10.1080/17576180.2024.2389637","url":null,"abstract":"<p><p><b>Aim:</b> This study aims to compare the anti-drug antibody (ADA) interference in four pharmacokinetic (PK) assays across different platforms (AlphaLISA, Gyrolab, LC-MS/MS) and to devise a strategy for ADA interference mitigation to improve the accuracy of measured drug in total PK assays.<b>Materials & methods:</b> Spiked test samples, created to achieve different ADA concentrations in human serum also containing an insulin analogue, were analyzed alongside pooled clinical samples using four assays.<b>Results & conclusion:</b> Interference was observed in all platforms. A novel approach using the Gyrolab mixing CD, including acid dissociation in the PK assay, significantly reduced interference and thereby improved relative error from >99% to ≤20% yielding measurements well within the acceptance criteria. Clinical sample results reinforced findings from the test samples.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11485705/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142279975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}