Bioanalysis最新文献

{"title":"Review on the bioanalysis of non-virus-based gene therapeutics.","authors":"Maotian Zhou, Xue Zhang, Huan Yan, Lili Xing, Yi Tao, Liang Shen","doi":"10.1080/17576180.2024.2437418","DOIUrl":"10.1080/17576180.2024.2437418","url":null,"abstract":"<p><p>Over the past years, gene therapeutics have held great promise for treating many inherited and acquired diseases. The increasing number of approved gene therapeutics and developing clinical pipelines demonstrate the potential to treat diseases by modifying their genetic blueprints in vivo. Compared with conventional treatments targeting proteins rather than underlying causes, gene therapeutics can achieve enduring or curative effects via gene activation, inhibition, and editing. However, the delivery of DNA/RNA to the target cell to alter the gene expression is a complex process that involves, crossing numerous barriers in both the extracellular and intracellular environment. Generally, the delivery strategies can be divided into viral-based and non-viral-based vectors. This review summarizes various bioanalysis strategies that support the non-virus-based gene therapeutics research, including pharmacokinetics (PK)/toxicokinetics (TK), biodistribution, immunogenicity evaluations for the gene cargo, vector, and possible expressed protein, and highlights the challenges and future perspectives of bioanalysis strategies in non-virus-based gene therapeutics. This review may provide new insights and directions for the development of emerging bioanalytical methods, offering technical support and a research foundation for innovative gene therapy treatments.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"1279-1294"},"PeriodicalIF":1.9,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11703353/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142823775","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}

{"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":" ","pages":"1-11"},"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}

{"title":"The synergy of nucleic acid amplification and miniaturized systems in enhancing liquid biopsy applications.","authors":"Ngoc Nguyen, Toi Vo Van, Trieu Nguyen","doi":"10.4155/bio-2023-0238","DOIUrl":"10.4155/bio-2023-0238","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"499-504"},"PeriodicalIF":1.9,"publicationDate":"2024-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11299790/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139911965","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}

{"title":"16^th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.","authors":"Jennifer Zimmer, Amanda Hays, Todd Lester, Manisha Diaz, Eric Thomas, Mark O'Dell, Elizabeth Hyer, Shabnam Tangri, Naveen Dakappagari, Moucun Yuan, Amy Lavelle, Shane Karnik, Aihua Liu, Bin Xu, Kurt Sales, Shashank Gorityala, Gregory Reynolds, Tim Sangster, Dean Franckaert, Iain Love, Vimal Patel, Martin Roberge, Jenny Lin, Erik Jerks, Tao Xu, Wei Garofolo, Sankeetha Nadarajah, Robert Kernstock, Dawn Dufield, David Ambrose, Dominic Warrino, Marsha Luna, Chantal Di Marco, Ariana Tudoroniu, Adriana Iordachescu, Mitesh Sanghvi, Hollie Barton, Michael Brown, Brian Hoffpauir, Agostinho Rocha, Kelly Dong, Jim Yamashita","doi":"10.1080/17576180.2024.2342691","DOIUrl":"10.1080/17576180.2024.2342691","url":null,"abstract":"<p><p>The 16th GCC Closed Forum was held in Orlando, FL, USA, on 23 June 2023. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: IS response, flow cytometry, changes to the bioanalytical industry, NGS assays, biomarker assay for tissues, dPCR validation, immunogenicity harmonization and ICH M10 implementation. Conclusions and consensus from discussions of these topics are included in this article.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"505-517"},"PeriodicalIF":1.9,"publicationDate":"2024-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11299793/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141305325","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}

{"title":"Simultaneous estimation of rutin and donepezil through RP-HPLC: implication in pharmaceutical and biological samples.","authors":"Rafquat Rana, Keerti Mishra, Shourya Tripathi, Animesh Kumar Gupta, Amrendra Kumar Tiwari, Pavan Kumar Yadav, Abhiram Kumar, Jvus Chakradhar, Sanjay Singh, Sonia Verma, Pooja Yadav, Manish K Chourasia","doi":"10.1080/17576180.2024.2344395","DOIUrl":"10.1080/17576180.2024.2344395","url":null,"abstract":"<p><p><b>Aim:</b> A HPLC method was developed and validated for the novel combination of rutin (RN) and donepezil (DNP). <b>Materials & methods:</b> RN and DNP were simultaneously eluted through a C18 column (Ø 150 × 4.6 mm) with a 60:40 v/v ratio of 0.1% formic acid aqueous solution to methanol at 0.5 ml/min. <b>Results:</b> The purposed method was found linear, selective, reproducible, accurate and precise with percent RSD less than 2. The limit of quantification for RN and DNP was found 3.66 and 3.25 μg/ml, respectively. <b>Conclusion:</b> Validated as per the ICH guidelines, the developed method efficiently quantified RN and DNP co-loaded in DQAsomes (121 nm) estimating matrix effect, release profile, entrapment efficiency, loading efficiency and <i>in vivo</i> plasma kinetics.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"557-567"},"PeriodicalIF":1.9,"publicationDate":"2024-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11299792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619206","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}

{"title":"An interview with <i>Bioanalysis</i>: speaking with the 2023 International Reid Bioanalytical Forum bursary award winners, part 1.","authors":"Esther May, Sam Morris, Afeefa Kiran Chaudhary, Sahand Shams, Thanyaporn Tengsuttiwat, Rajit Kolamunne, Jack Lodge","doi":"10.4155/bio-2024-0050","DOIUrl":"10.4155/bio-2024-0050","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":"16 7","pages":"121-125"},"PeriodicalIF":1.9,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845100/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140206291","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}

{"title":"Comprehensive performance evaluation of ligand-binding assay-LC-MS/MS method for co-dosed monoclonal anti-SARS-CoV-2 antibodies (AZD7442).","authors":"Yue Huang, Michael Shane Woolf, Chun-Chi Wang, Sami M Naser, Aaron M Wheeler, William R Mylott, Eric Ma, Anton I Rosenbaum","doi":"10.4155/bio-2023-0225","DOIUrl":"10.4155/bio-2023-0225","url":null,"abstract":"<p><p><b>Aims:</b> AZD7442 is a combination SARS-CoV-2 therapy comprising two co-dosed monoclonal antibodies. <b>Materials & methods:</b> The authors validated a hybrid ligand-binding assay-LC-MS/MS method for pharmacokinetic assessment of AZD7442 in human serum with nominal concentration range of each analyte of 0.300-30.0 μg/ml. <b>Results:</b> Validation results met current regulatory acceptance criteria. The validated method supported three clinical trials that spanned more than 17 months and ≥720 analytical runs (∼30,000 samples and ∼3000 incurred sample reanalyses per analyte). The data generated supported multiple health authority interactions, across the globe. AZD7442 (EVUSHELD) was approved in 12 countries for pre-exposure prophylaxis of COVID-19. <b>Conclusion:</b> The results reported here demonstrate the robust, high-throughput capability of the hybrid ligand-binding assay-LC-MS/MS approach being employed to support-next generation versions of EVUSHELD, AZD3152.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"149-163"},"PeriodicalIF":1.9,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845114/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139929856","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}

{"title":"2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard <u>(Part 3</u> - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).","authors":"Johanna Mora, Rachel Palmer, Leslie Wagner, Bonnie Wu, Michael Partridge, Meena, Ivo Sonderegger, John Smeraglia, Nicoletta Bivi, Naveen Dakappagari, Sandra Diebold, Fabio Garofolo, Christine Grimaldi, Warren Kalina, John Kamerud, Sumit Kar, Jean-Claude Marshall, Christian Mayer, Andrew Melton, Keith Merdek, Katrina Nolan, Serge Picard, Weiping Shao, Jessica Seitzer, Yoichi Tanaka, Omar Tounekti, Adam Vigil, Karl Walravens, Joshua Xu, Weifeng Xu, Yuanxin Xu, Lin Yang, Liang Zhu, Daniela Verthelyi, Robert J Kubiak, Kelly Coble, Swati Gupta, Mohsen Rajabi Abhari, Susan Richards, Yuan Song, Martin Ullmann, Boris Calderon, Isabelle Cludts, George R Gunn, Shalini Gupta, Akiko Ishii-Watabe, Mohanraj Manangeeswaran, Kimberly Maxfield, Fred McCush, Christine O'Day, Kate Peng, Johann Poetzl, Michele Rasamoelisolo, Ola M Saad, Kara Scheibner, Sophie Shubow, Sam Song, Seth Thacker","doi":"10.4155/bio-2024-0024","DOIUrl":"10.4155/bio-2024-0024","url":null,"abstract":"<p><p>The 17^th Workshop on Recent Issues in Bioanalysis (17^th WRIB) took place in Orlando, FL, USA on June 19-23, 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17^th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on \"EU IVDR 2017/746 Implementation and impact for the Global Biomarker Community: How to Comply with these NEW Regulations\" and on \"US FDA/OSIS Remote Regulatory Assessments (RRAs)\" were the special features of the 17^th edition. As in previous years, WRIB continued to gather a wide diversity of international, industry opinion leaders and regulatory authority experts working on both small and large molecules as well as gene, cell therapies and vaccines to facilitate sharing and discussions focused on improving quality, increasing regulatory compliance, and achieving scientific excellence on bioanalytical issues. This 2023 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2023 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 3) covers the recommendations on Gene Therapy, Cell therapy, Vaccines and Biotherapeutics Immunogenicity. Part 1A (Mass Spectrometry Assays and Regulated Bioanalysis/BMV), P1B (Regulatory Inputs) and Part 2 (Biomarkers, IVD/CDx, LBA and Cell-Based Assays) are published in volume 16 of Bioanalysis, issues 8 and 9 (2024), respectively.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"77-119"},"PeriodicalIF":1.9,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11849449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139929855","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}

{"title":"Immunocapture LC-MS methods for pharmacokinetics of large molecule drugs.","authors":"Emily G Werth, David Roos, Elsy T Philip","doi":"10.4155/bio-2023-0261","DOIUrl":"10.4155/bio-2023-0261","url":null,"abstract":"<p><p>Implementation of immunocapture LC-MS methods to characterize the pharmacokinetic profile of large molecule drugs has become a widely used technique over the past decade. As the pharmaceutical industry strives for speediness into clinical development without jeopardizing quality, robust assays with generic application across the pipeline are becoming instrumental in bioanalysis, especially in early-stage development. This review highlights the capabilities and challenges involved in hybrid immunocapture LC-MS techniques and its continued applications in nonclinical and clinical pharmacokinetic assay design. This includes a comparison of LC-MS-based approaches to conventional ligand-binding assays and the driving demands in large molecule drug portfolios including growing sensitivity requirements and the unique challenges of new modalities requiring innovation in the bioanalytical laboratory.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"165-177"},"PeriodicalIF":1.9,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845110/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721446","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}

{"title":"Development of LC-MS/MS method for cyanoenone triterpenoid determination to support CNS tissue distribution study.","authors":"Lynn Tian, William Lafon, Qingguo Tian, Edward Tamer","doi":"10.4155/bio-2023-0246","DOIUrl":"10.4155/bio-2023-0246","url":null,"abstract":"<p><p><b>Aims:</b> Cyanoenone triterpenoids penetrate the CNS, exhibiting biological activity via the nuclear factor E2-related factor (Nrf2) pathway. This is the first report on methods for the quantification of cyanonenone triterpenoids' distribution in various CNS tissues by LC-MS/MS. <b>Materials & methods:</b> The analyte was extracted from brain tissue homogenate using protein precipitation and supported liquid extraction. <b>Results & conclusion:</b> The assay validated a quantification range of 3.00-3000 ng/g in brain tissue samples as low as 5 mg. All parameters, including interference (≤20% at LLOQ) and accuracy/precision (15%, with 20% at LLOQ), met acceptance criteria. This assay supported a CNS distribution study, analyzing more than 10 mouse brain regions successfully.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":" ","pages":"127-134"},"PeriodicalIF":1.9,"publicationDate":"2024-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11845120/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139911963","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}