Bioanalysis, Volume 16, Issue 7 (2024)

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Bioanalysis, Volume 16, Issue 7 (2024)

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White Paper

Discussion
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 (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization)
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
Pages: 77-119
Published online: 22 Feb 2024
Abstractfor2023 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 (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization) | Full Text | References | PDF (2.7 MB) | EPUB
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Interview

Discussion
An Interview with Bioanalysis: Speaking with the 2023 International Reid Bioanalytical Forum Bursary Award Winners, Part 1
Esther May, Sam Morris, Afeefa Kiran Chaudhary, Sahand Shams, Thanyaporn Tengsuttiwat, Rajit Kolamunne & Jack Lodge
Pages: 121-125
Published online: 08 Apr 2024
First Page PreviewforAn Interview with Bioanalysis: Speaking with the 2023 International Reid Bioanalytical Forum Bursary Award Winners, Part 1 | Full Text | PDF (368.3 KB) | EPUB
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Methodology

Article
Development of LC–MS/MS Method for Cyanoenone Triterpenoid Determination to Support CNS Tissue Distribution Study
Lynn Tian, William Lafon, Qingguo Tian & Edward Tamer
Pages: 127-134
Published online: 21 Feb 2024
AbstractforDevelopment of LC–MS/MS Method for Cyanoenone Triterpenoid Determination to Support CNS Tissue Distribution Study | Full Text | References | PDF (864.6 KB) | EPUB
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Research Article

Article
Eliminating Drug Target Interference with Specific Antibody or its F(ab′)2 Fragment in the Bridging Immunogenicity Assay
Xiaojie Deng, Yingying Hou, Wenyi Yuan, Hongzhou Yang, Ruowen Guo, Tingting Liu, Yongzhen Liu, Junjiu Xu, Heng Liu, Likun Gong & Qiuping Qin
Pages: 135-148
Published online: 08 Apr 2024
AbstractforEliminating Drug Target Interference with Specific Antibody or its F(ab′)2 Fragment in the Bridging Immunogenicity Assay | Full Text | References | PDF (1.2 MB) | EPUB | Supplemental
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Article
Comprehensive Performance Evaluation of Ligand-Binding Assay–LC–MS/MS Method for Co-Dosed Monoclonal Anti-SARS-CoV-2 Antibodies (AZD7442)
Yue Huang, Michael Shane Woolf, Chun-Chi Wang, Sami M Naser, Aaron M Wheeler, William R Mylott Jr, Eric Ma & Anton I Rosenbaum
Pages: 149-163
Published online: 22 Feb 2024
AbstractforComprehensive Performance Evaluation of Ligand-Binding Assay–LC–MS/MS Method for Co-Dosed Monoclonal Anti-SARS-CoV-2 Antibodies (AZD7442) | Full Text | References | PDF (4.4 MB) | EPUB | Supplemental
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Review

Review Article
Immunocapture LC–MS Methods for Pharmacokinetics of Large Molecule Drugs
Emily G Werth, David Roos & Elsy T Philip
Pages: 165-177
Published online: 13 Feb 2024
AbstractforImmunocapture LC–MS Methods for Pharmacokinetics of Large Molecule Drugs | Full Text | References | PDF (1.1 MB) | EPUB
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Open Access

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