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Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 1: "The What"). 透视研究和监管生物分析中用于生物治疗和生物标记蛋白质的液相色谱-质谱联用仪（/MS）：欧洲生物分析论坛社区十多年来的经验总结（第 1 部分："什么"）。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-11-06 DOI: 10.1080/17576180.2024.2418250
Amanda Wilson, Mark Jean Gnoth, Nico van de Merbel, Peter Blattmann, Benno Ingelse, Gregor Jordan, Fabrizia Fusetti, Michael Blackburn, Sune Hove Sporring, Iain Love, Stephane Muccio, Matthew Barfield, Rob Wheller, Philip Timmerman
{"title":"Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 1: \"The What\").","authors":"Amanda Wilson, Mark Jean Gnoth, Nico van de Merbel, Peter Blattmann, Benno Ingelse, Gregor Jordan, Fabrizia Fusetti, Michael Blackburn, Sune Hove Sporring, Iain Love, Stephane Muccio, Matthew Barfield, Rob Wheller, Philip Timmerman","doi":"10.1080/17576180.2024.2418250","DOIUrl":"10.1080/17576180.2024.2418250","url":null,"abstract":"<p><p>Following up on our most recent discussion paper focusing on the continued regulatory challenges for bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS, the European Bioanalysis Forum reports back on their internal discussions on and experience with method development for biotherapeutic and biomarker proteins in research and regulated bioanalysis. Due to the broad array of topics discussed, this information is spread over two research papers, where one focusses on the fundamental principles on which the technology is built (i.e., the what?) and another on the practical considerations (i.e., the how). In this paper, we discuss 'the what'. Both papers should be helpful for the bioanalytical community to better understand the challenges and provide an insight on why bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS should not be compared with the more traditional LC-MS/MS assay for small molecules or ligand binding assays for biotherapeutics.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589981","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}
引用次数: 0
Cross-validation of pharmacokinetic assays post-ICH M10 is not a pass/fail criterion. ICH M10 后的药代动力学测定的交叉验证不是通过/失败标准。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-11-06 DOI: 10.1080/17576180.2024.2418284
Marianne Scheel Fjording, Joanne Goodman, Chad Briscoe
{"title":"Cross-validation of pharmacokinetic assays post-ICH M10 is not a pass/fail criterion.","authors":"Marianne Scheel Fjording, Joanne Goodman, Chad Briscoe","doi":"10.1080/17576180.2024.2418284","DOIUrl":"10.1080/17576180.2024.2418284","url":null,"abstract":"<p><p>The ICH M10 guideline establishes global standards for bioanalytical method validation for pharmacokinetic assays, focusing on data reliability and accuracy across studies. A significant component is cross-validation, which should be performed to ensure data comparability when multiple methods or laboratories are involved in a single study or across studies where comparison will be performed. However, ICH M10 does not specify acceptance criteria for cross-validation, creating challenges for the industry because traditionally many laboratories have always utilized acceptance criteria to \"pass\" or \"fail\" the study. This editorial discusses how bioanalytical labs should conduct cross-validation for PK assays post-ICH M10, highlighting the role of statistical methods and the need for close collaboration with clinical pharmacology and biostatistics departments. Proper implementation and strategic focus on relevant studies are essential for effective cross-validation.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589978","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}
引用次数: 0
Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 2: "The How"). 透视研究和监管生物分析中用于生物治疗和生物标记蛋白质的液相色谱-质谱联用仪（/MS）：欧洲生物分析论坛社区十多年来的经验总结（第 2 部分："如何"）。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-11-06 DOI: 10.1080/17576180.2024.2418251
Nico van de Merbel, Mark Jean Gnoth, Amanda Wilson, Peter Blattmann, Benno Ingelse, Gregor Jordan, Fabrizia Fusetti, Michael Blackburn, Sune Hove Sporring, Iain Love, Stephane Muccio, Matthew Barfield, Rob Wheller, Philip Timmerman
{"title":"Perspective on LC-MS(/MS) for biotherapeutic and biomarker proteins in research and regulated Bioanalysis: a consolidation of more than a decade of experience across the European Bioanalysis Forum community (Part 2: \"The How\").","authors":"Nico van de Merbel, Mark Jean Gnoth, Amanda Wilson, Peter Blattmann, Benno Ingelse, Gregor Jordan, Fabrizia Fusetti, Michael Blackburn, Sune Hove Sporring, Iain Love, Stephane Muccio, Matthew Barfield, Rob Wheller, Philip Timmerman","doi":"10.1080/17576180.2024.2418251","DOIUrl":"10.1080/17576180.2024.2418251","url":null,"abstract":"<p><p>Following up on our most recent discussion paper focussing on the continued regulatory challenges for bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS, the European Bioanalysis Forum reports back on their internal discussions on and experience with method development for biotherapeutic and biomarker proteins in research and regulated Bioanalysis. Due to the broad array of topics discussed, this information is spread over two research papers, where one focusses on the fundamental principles on which the technology is built (i.e., the what) and another on the practical considerations (i.e., the how). In this paper, we discuss 'the how'. Both papers should be helpful for the bioanalytical community to better understand the challenges and provide an insight on why bioanalysis of biotherapeutic and biomarker proteins with LC-MS/MS should not be compared with the more traditional LC-MS/MS assay for small molecules or ligand binding assays for biotherapeutics.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142589985","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}
引用次数: 0
Peripheral blood mononuclear cells isolation from mouse and rabbit blood to quantify active nucleotide and define brincidofovir dose for smallpox. 从小鼠和家兔血液中分离外周血单核细胞，以量化活性核苷酸并确定治疗天花的布林昔多福韦剂量。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-10-30 DOI: 10.1080/17576180.2024.2418245
Robert Hart, Shane Karnik, Kathy Van Sickle, Mark Mullin, Odin Naderer, Tim Tippin, John Dunn
{"title":"Peripheral blood mononuclear cells isolation from mouse and rabbit blood to quantify active nucleotide and define brincidofovir dose for smallpox.","authors":"Robert Hart, Shane Karnik, Kathy Van Sickle, Mark Mullin, Odin Naderer, Tim Tippin, John Dunn","doi":"10.1080/17576180.2024.2418245","DOIUrl":"https://doi.org/10.1080/17576180.2024.2418245","url":null,"abstract":"<p><p><b>Aim:</b> Brincidofovir has been approved by the US FDA for the treatment of smallpox via the \"Animal Rule\". The active moiety, cidofovir diphosphate (CDV-PP), was measurable in human peripheral blood mononuclear cells (PBMCs), but quantitation in animals was challenging given their limited blood volume. The aim of this study was to optimize PBMC isolation from rabbit and mouse blood to allow quantitation of CDV-PP.<b>Materials & methods:</b> PBMC isolation methods using various separation media were evaluated using blood from naive and brincidofovir-dosed animals. CDV-PP was quantified using liquid chromatography tandem mass spectrometry.<b>Results & conclusion:</b> PBMC isolation yields were increased by >fourfold compared with yields obtained using human methods, allowing cross-species exposure comparisons.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142543403","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}
引用次数: 0
Moving into the cloud: a summary from a European Bioanalysis forum workshop on introducing cloud applications in bioanalytical laboratories. 迈入云时代：欧洲生物分析论坛关于在生物分析实验室引入云应用的研讨会摘要。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-10-30 DOI: 10.1080/17576180.2024.2416357
Cecilia Arfvidsson, Katja Zeiser, Lars-Ole Andresen, David Van Bedaf, Harm Buddiger, Christopher Jones, Werner Schauerte, Jens Sigh, Milan Vagaday, Philip Timmerman
{"title":"Moving into the cloud: a summary from a European Bioanalysis forum workshop on introducing cloud applications in bioanalytical laboratories.","authors":"Cecilia Arfvidsson, Katja Zeiser, Lars-Ole Andresen, David Van Bedaf, Harm Buddiger, Christopher Jones, Werner Schauerte, Jens Sigh, Milan Vagaday, Philip Timmerman","doi":"10.1080/17576180.2024.2416357","DOIUrl":"https://doi.org/10.1080/17576180.2024.2416357","url":null,"abstract":"<p><p>In this manuscript, we summarize the discussions and key messages from developed in the e-environment team of the European Bioanalysis forum, which were the basis of a subsequent workshop on cloud applications in a regulated bioanalysis lab environment, hosted by the European Bioanalysis Forum e-environment team at their 16th Open Symposium in Barcelona, Spain in November 2023. The purpose of our discussions is to provide further insight and understanding on the status of having cloud applications implemented in a regulated bioanalysis laboratory and the challenges experienced. The discussions highlight the importance of cross functional collaboration during the entire process of cloud implementation and some of the uncertainties in the different functions' roles and responsibilities.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142543402","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}
引用次数: 0
Two decades of immunocapture liquid chromatography tandem mass spectrometry for pharmaceutical discovery and development: reflections and recommendations for optimal deployment. 免疫捕获液相色谱串联质谱用于药物发现和开发二十年：反思与优化部署建议。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-10-28 DOI: 10.1080/17576180.2024.2415763
Bradley L Ackermann
{"title":"Two decades of immunocapture liquid chromatography tandem mass spectrometry for pharmaceutical discovery and development: reflections and recommendations for optimal deployment.","authors":"Bradley L Ackermann","doi":"10.1080/17576180.2024.2415763","DOIUrl":"https://doi.org/10.1080/17576180.2024.2415763","url":null,"abstract":"","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493917","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}
引用次数: 0
The use of surrogate matrices in bioanalytical preclinical safety testing using chromatographic methods: a recommendation from the European Bioanalysis forum. 使用色谱法在生物分析临床前安全性测试中使用替代基质：欧洲生物分析论坛的建议。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-10-23 DOI: 10.1080/17576180.2024.2416360
Lee Goodwin, Stuart McDougall, Mark Jean Gnoth, Daniel Mascher, Luca Ferrari, Robert Wheller, Hayley Hawthorne, Josep-Maria Jansat, Joerg Faber, Peter Huber, Alessandro Greco, Lars F Eggers, Matthias Sury, Jens-Jakob Karlsson, Sune Hove Sporring, Susanne Globig, Nico van de Merbel, Philip Timmerman
{"title":"The use of surrogate matrices in bioanalytical preclinical safety testing using chromatographic methods: a recommendation from the European Bioanalysis forum.","authors":"Lee Goodwin, Stuart McDougall, Mark Jean Gnoth, Daniel Mascher, Luca Ferrari, Robert Wheller, Hayley Hawthorne, Josep-Maria Jansat, Joerg Faber, Peter Huber, Alessandro Greco, Lars F Eggers, Matthias Sury, Jens-Jakob Karlsson, Sune Hove Sporring, Susanne Globig, Nico van de Merbel, Philip Timmerman","doi":"10.1080/17576180.2024.2416360","DOIUrl":"https://doi.org/10.1080/17576180.2024.2416360","url":null,"abstract":"<p><p>Within the bioanalytical community, the use of blank matrix from preclinical animals for bioanalytical method validation and sample analysis is common practice and required in the context of guidelines for bioanalytical method validation. At the same time, its use has been challenged by the scientific community for decades, since there is ample scientific evidence to allow the use surrogate matrices for this purpose. Nevertheless, legacy and current regulatory thinking continues to be reluctant to allow the use of surrogate matrices in bioanalytical testing except for so-called rare matrices. As part of ongoing discussions in relation to the ICH M10 Guideline, the European Bioanalysis Forum re-challenges the unnecessary use of blank matrices from preclinical animals and believes that, as part of community responsibility and ethical standards and when supported by data, the use of surrogate matrices should become widely accepted. It is in this context that targeted experiments were conducted within the European Bioanalysis Forum to gather additional data and re-open the discussions with all involved and that it should become acceptable to use surrogate matrices wherever possible.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493916","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}
引用次数: 0
A comparison of branched DNA and reverse transcriptase quantitative polymerase chain reaction methodologies for quantitation of lipid nanoparticle encapsulated mRNA. 比较支链 DNA 和逆转录酶定量聚合酶链反应方法对脂质纳米颗粒封装的 mRNA 进行定量。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-10-18 DOI: 10.1080/17576180.2024.2411914
Syed Ali, Matt Bruno, Caleb Celestin, Pratibha Chauhan, Marissa Mitola, Shilpa Sharma, Chiaowen Joyce Hsiao, Mengying Li, Lei Ci, Douglas Burdette, Harkewal Singh
{"title":"A comparison of branched DNA and reverse transcriptase quantitative polymerase chain reaction methodologies for quantitation of lipid nanoparticle encapsulated mRNA.","authors":"Syed Ali, Matt Bruno, Caleb Celestin, Pratibha Chauhan, Marissa Mitola, Shilpa Sharma, Chiaowen Joyce Hsiao, Mengying Li, Lei Ci, Douglas Burdette, Harkewal Singh","doi":"10.1080/17576180.2024.2411914","DOIUrl":"https://doi.org/10.1080/17576180.2024.2411914","url":null,"abstract":"<p><p>Messenger RNA (mRNA)-based therapeutics have emerged as a promising modality for various clinical applications, necessitating robust methods for mRNA quantification. This biodistribution study compares the performance of branched DNA and reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) assays for measuring lipid nanoparticle-encapsulated mRNA. Following intravenous administration of nascent peptide imaging luciferase mRNA (1 mg/kg) to rats, mRNA levels in various tissues and serum were quantified using both assays. Statistical analyses, including Bland-Altman, Deming regression and Passing-Bablok regression, were employed to assess method comparability and reproducibility. The results indicated that mRNA pharmacokinetics measured by branched DNA and RT-qPCR were largely consistent across tissues, with RT-qPCR showing greater reproducibility across multiple laboratories. RT-qPCR also demonstrated a wider dynamic range and higher sensitivity, making it a more versatile option for large-scale studies. Despite some differences in data due to tissue types and timepoints, both methods provided comparable pharmacokinetic profiles for mRNA quantification. This study underscores the importance of selecting an appropriate quantification method based on study requirements and highlights RT-qPCR's adaptability for multisite research, especially for the clinical development of mRNA-based therapeutics.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142457040","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}
引用次数: 0
Immunocapture mass spectrometry: macroscopic history, recent trends and future prospects. 免疫捕获质谱：宏观历史、最新趋势和未来展望。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-10-17 DOI: 10.1080/17576180.2024.2413277
Makoto Niwa
{"title":"Immunocapture mass spectrometry: macroscopic history, recent trends and future prospects.","authors":"Makoto Niwa","doi":"10.1080/17576180.2024.2413277","DOIUrl":"https://doi.org/10.1080/17576180.2024.2413277","url":null,"abstract":"<p><p>Literature on immunological pretreatment and mass spectrometry was searched in the Web of Science database. The collected data were utilized for bibliometric analysis and literature review to identify trends in this field. Immunological pretreatment initially began in chemical toxicology using gas chromatography mass spectrometry and research interests later shifted to biologics pharmacokinetics, biomarkers, anti-drug antibodies and diagnosis. The key advantage of using mass spectrometry was the ability to distinguish molecular subtypes. Future research interests are expected to focus on a broader range of analyte types (such as intact protein mass spectrometry) and methodological improvements, including better protein digestion and microfluidics, aiming for faster, less labor-intensive and more reliable analysis through multiplexing and automation.</p>","PeriodicalId":8797,"journal":{"name":"Bioanalysis","volume":null,"pages":null},"PeriodicalIF":1.9,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142457044","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}
引用次数: 0
Development of pseudotyped VSV-SARS-CoV-2 spike variants for the assessment of neutralizing antibodies. 开发用于评估中和抗体的伪型 VSV-SARS-CoV-2 穗状变体。
IF 1.9 4区 医学
Bioanalysis Pub Date : 2024-10-16 DOI: 10.1080/17576180.2024.2411920
Atike Nur Cimen, Gizem Celebi Torabfam, Yesim Tuyji Tok, Ebru Yucebag, Nese Arslan, Devrim Saribal, Gulen Esken, Ozlem Dogan, Mert Ahmet Kuskucu, Bilgul Mete, Gokhan Aygun, Fehmi Tabak, Fusun Can, Onder Ergonul, Kenan Midilli, Ozlem Kutlu, Sibel Cetinel
{"title":"Development of pseudotyped VSV-SARS-CoV-2 spike variants for the assessment of neutralizing antibodies.","authors":"Atike Nur Cimen, Gizem Celebi Torabfam, Yesim Tuyji Tok, Ebru Yucebag, Nese Arslan, Devrim Saribal, Gulen Esken, Ozlem Dogan, Mert Ahmet Kuskucu, Bilgul Mete, Gokhan Aygun, Fehmi Tabak, Fusun Can, Onder Ergonul, Kenan Midilli, Ozlem Kutlu, Sibel Cetinel","doi":"10.1080/17576180.2024.2411920","DOIUrl":"https://doi.org/10.1080/17576180.2024.2411920","url":null,"abstract":"<p><p><b>Aim:</b> Serological studies with pseudotyped viruses offer a safer alternative to live SARS-CoV-2 in evaluating neutralizing antibodies, enabling research in standard labs.<b>Methods:</b> The SARS-CoV-2 Spike pseudotyped vesicular stomatitis virus (VSV) pseudoviruses were generated using Spike of Wuhan strain and two variants (B.1.1.7, B.1.351) and utilized to evaluate the serum neutralizing activity of human plasma samples of vaccinated (n = 13) and healthy people (n = 2) compared with a plaque assay with authentic virus.<b>Results:</b> Neutralizing titer of convalescent plasma resulted with a good correlation (R<sup>2</sup> = 0.7).<b>Conclusion:</b> We evaluated a safe and reliable pseudotyped virus system that effectively mimics authentic virus and correlates well with traditional assays. The developed system allows easier testing of variants and has the potential to improve vaccine development.</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":"142457043","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}
引用次数: 0
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