Bioanalysis, Volume 15, Issue 14 (2023)

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Bioanalysis, Volume 15, Issue 14 (2023)

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White Paper

Discussion
2022 White Paper on Recent Issues in Bioanalysis: Fda Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, Lnp & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, Ada Affinity, Risk-Based Approaches, Ngs, Qpcr, Ddpcr Assays (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)
Luying Pan, Johanna Mora, Karl Walravens, Leslie Wagner, Shirley Hopper, Lina Loo, David Bettoun, Sarah Bond, Francis Dessy, Sean Downing, Fabio Garofolo, Soumi Gupta, Neil Henderson, Chad Irwin, Akiko Ishii-Watabe, Sumit Kar, Vibha Jawa, Julie Joseph, Ludovic Malvaux, Jean-Claude Marshall, Jessica McDevitt, Susovan Mohapatra, Jessica Seitzer, Justin Smith, Therese Solstad, Hiroshi Sugimoto, Omar Tounekti, Bonnie Wu, Yuling Wu, Yuanxin Xu, Joshua Xu, Takenori Yamamoto, Lin Yang, Albert Torri, Susan Kirshner, Kimberly Maxfield, Joao Pedras Vasconcelos, Mohsen Rajabi Abhari, Daniela Verthelyi, Eric Brodsky, Montserrat Carrasco-Triguero, John Kamerud, Matthew Andisik, Daniel Baltrukonis, Nicoletta Bivi, Isabelle Cludts, Kelly Coble, Boris Gorovits, George R Gunn, Swati Gupta, Anders Holm Millner, Alison Joyce, Robert J Kubiak, Seema Kumar, Karen Liao, Mohanraj Manangeeswaran, Michael Partridge, Samuel Pine, Johann Poetzl, Manoj Rajadhyaksha, Michele Rasamoelisolo, Susan Richards, Yuan Song, Steven Swanson, Seth Thacker, Meenu Wadhwa, Andreas Wolf, Lucia Zhang & Lin Zhou
Pages: 773-814
Published online: 01 Aug 2023
Abstractfor2022 White Paper on Recent Issues in Bioanalysis: Fda Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, Lnp & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, Ada Affinity, Risk-Based Approaches, Ngs, Qpcr, Ddpcr Assays (Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach) | Full Text | References | PDF (829.2 KB) | EPUB
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Free Access

Commentary

Editorial
Uncovering the Green Frontier: Harnessing Deep Eutectic Solvents for Sustainable Bioanalysis
Priyanka A Shah, Pranav S Shrivastav, Vinay S Sharma & Vishwajit Chavda
Pages: 815-821
Published online: 08 Aug 2023
First Page PreviewforUncovering the Green Frontier: Harnessing Deep Eutectic Solvents for Sustainable Bioanalysis | Full Text | References | PDF (254.1 KB) | EPUB
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Methodology

Article
High Ionic Strength Dissociation Assay Reduces Dimeric Target Interference in Immunogenicity Testing
Alexander Pöhler, Cordula Jany, Joachim Butzer, Thomas Bach, Eugenia Opolka-Hoffmann, Roland F Staack & Gregor Jordan
Pages: 823-832
Published online: 16 Jun 2023
AbstractforHigh Ionic Strength Dissociation Assay Reduces Dimeric Target Interference in Immunogenicity Testing | Full Text | References | PDF (1.5 MB) | EPUB
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Open Access

Preliminary Communication

Brief Report
A Sensitive LC–MS/MS Assay to Quantitate Free Payload Aur0101 from ADC PYX-201 in Rat and Monkey Plasma
Feng Yin, Farah Ahsan, Jan Pinkas, Biplab Das, Frank Wang, Nancy Zheng, David Hahn, Aniruddha Amrite, Jianwen Feng, Diana Adhikari, Jack Sikora, Elizabeth Shaheen & Shawn Harriman
Pages: 833-843
Published online: 16 Aug 2023
AbstractforA Sensitive LC–MS/MS Assay to Quantitate Free Payload Aur0101 from ADC PYX-201 in Rat and Monkey Plasma | Full Text | References | PDF (702.2 KB) | EPUB | Supplemental
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Research Article

Article
Volumetric Absorptive Microsampling as An Effective Microsampling Technique for LC–MS/MS Bioanalysis of Biomarkers in Drug Discovery
Unnati Kapadnis, Chuck Locuson, Heidi Okamura, Gianluca De Rienzo, Cece Cotter, Dongwei Zhu, Rohini Narayanaswami, Jose Castro-Perez, Punit Marathe & Wen-Chu Yang
Pages: 845-859
Published online: 12 Jun 2023
AbstractforVolumetric Absorptive Microsampling as An Effective Microsampling Technique for LC–MS/MS Bioanalysis of Biomarkers in Drug Discovery | Full Text | References | PDF (567.7 KB) | EPUB | Supplemental
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