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White Paper

2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC & Part 1B - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine)

Surinder Kaur1 Genentech, South San Francisco, CA, USA

Stephen C Alley2 Seattle Genetics, Bothell, WA, USA

Matt Szapacs3 Abbvie, Philadelphia, PA, USA

Amanda Wilson18 Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK

Eugene Ciccimaro4 Bristol-Myers Squibb, Lawrenceville, NJ, USA

Dian Su5 Mersana, Cambridge, MA, USA

Neil Henderson7 Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden

Linzhi Chen6 Boehringer Ingelheim, Ridgefield, CT, USA

Fabio Garofolo33 BRI - a Frontage Company, Vancouver, BC, CanadaCorrespondence[email protected]

Shawna Hengel2 Seattle Genetics, Bothell, WA, USA

Wenying Jian8 Janssen Research & Development, Spring House, PA, USA

John F Kellie9 GlaxoSmithKline, Collegeville, PA, USA

Anita Lee10 Merck, Kenilworth, NJ, USA

John Mehl9 GlaxoSmithKline, Collegeville, PA, USA

Joe Palandra11 Pfizer, Andover, MA, USA

Haibo Qiu12 Regeneron, Tarrytown, NY, USA

Natasha Savoie39 WRIB, Montreal, QC, Canada

Diaa Shakleya13 US FDA, Silver Spring, MD, USA

Ludovicus Staelens14 UCB, Braine l'Alleud, Belgium

Hiroshi Sugimoto15 Takeda, Cambridge, MA, USA

Giane Sumner12 Regeneron, Tarrytown, NY, USA

Jan Welink16 EU EMA, Amsterdam, Netherlands

Robert Wheller17 LGC, Fordham, UK

Y J Xue4 Bristol-Myers Squibb, Lawrenceville, NJ, USA

Jianing Zeng4 Bristol-Myers Squibb, Lawrenceville, NJ, USA

Jinhui Zhang13 US FDA, Silver Spring, MD, USA

Huiyu Zhou19 BioMarin, Novato, CA, USA

Jian Wang21 Crinetics, San Diego, CA, USA

Scott Summerfield22 GlaxoSmithKline, Stevenage, UK

Olga Kavetska30 Pfizer, Groton, CT, USA

Lieve Dillen24 Janssen Research & Development, Beerse, Belgium

Ragu Ramanathan20 Vertex, Boston, MA

Mike Baratta15 Takeda, Cambridge, MA, USA

Arindam Dasgupta13 US FDA, Silver Spring, MD, USA

Anna Edmison25 Health Canada, Ottawa, ON, Canada

Luca Ferrari26 F. Hoffmann-La Roche Ltd, Basel, Switzerland

Sally Fischer1 Genentech, South San Francisco, CA, USA

Daniela Fraier26 F. Hoffmann-La Roche Ltd, Basel, Switzerland

Sam Haidar13 US FDA, Silver Spring, MD, USA

Kathrin Heermeier27 Sanofi, Frankfurt, Germany

Christopher James28 Amgen Research, Thousand Oaks, CA, USA

Allena Ji29 Sanofi, Framingham, MA, USA

Lina Luo30 Pfizer, Groton, CT, USA

Gustavo Mendes Lima Santos31 Brazil ANVISA, Brasilia, Brazil

Noah Post32 Ionis, Carlsbad, CA, USA

Anton I Rosenbaum34 Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, South San Francisco, CA, USA

Sune Sporring34 Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, South San Francisco, CA, USA

Sekhar Surapaneni4 Bristol-Myers Squibb, Lawrenceville, NJ, USA

Stephen Vinter35 Novo Nordisk, Maaloev, Denmark

Katty Wan30 Pfizer, Groton, CT, USA

Eric Woolf36 UK MHRA, London, UK

Olga Kavetska30 Pfizer, Groton, CT, USA

Seongeun (Julia) Cho13 US FDA, Silver Spring, MD, USA

Elham Kossary38 WHO, Geneva, Switzerland

Sandra Prior36 UK MHRA, London, UK

Mohsen Rajabi Abhari13 US FDA, Silver Spring, MD, USA

Catherine Soo25 Health Canada, Ottawa, ON, Canada

Yow-Ming Wang13 US FDA, Silver Spring, MD, USA

Abbas Bandukwala13 US FDA, Silver Spring, MD, USA

Elana Cherry25 Health Canada, Ottawa, ON, Canada

Isabelle Cludts36 UK MHRA, London, UK

Soma Ghosh13 US FDA, Silver Spring, MD, USA

Shirley Hopper36 UK MHRA, London, UK

Akiko Ishii-Watabe38 WHO, Geneva, Switzerland

Susan Kirshner13 US FDA, Silver Spring, MD, USA

Kevin Maher13 US FDA, Silver Spring, MD, USA

Kimberly Maxfield13 US FDA, Silver Spring, MD, USA

Joao Pedras-Vasconcelos13 US FDA, Silver Spring, MD, USA

Yoshiro Saito40 Japan MHLW, Tokyo, Japan

Dean Smith25 Health Canada, Ottawa, ON, Canada

Therese Solstad41 Norway NoMA, Oslo, Norway

Daniela Verthelyi13 US FDA, Silver Spring, MD, USA

Meenu Wadhwa36 UK MHRA, London, UK;37 Merck, West Point, PA, USA

Leslie Wagner13 US FDA, Silver Spring, MD, USA

Günter Waxenecker42 Austria AGES, Vienna, Austria

Haoheng Yan13 US FDA, Silver Spring, MD, USA

Lucia Zhang25 Health Canada, Ottawa, ON, Canada

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Matt Szapacs, Wenying Jian, Daniel Spellman, Jennifer Cunliffe, Elizabeth Verburg, Surinder Kaur, John Kellie, Wenkui Li, John Mehl, Mark Qian, Xiazi Qiu, Federico Riccardi Sirtori, Anton I. Rosenbaum, Tim Sikorski, Sekhar Surapaneni, Jian Wang, Amanda Wilson, Jinhui Zhang, Yongjun Xue, Noah Post, Yue Huang, Dina Goykhman, Long Yuan, Kasie Fang, Ellen Casavant, Linzhi Chen, Yunlin Fu, Ming Huang, Allena Ji, Jay Johnson, Michael Lassman, Jing Li, Ola Saad, Hetal Sarvaiya, Lin Tao, Yuting Wang, Naiyu Zheng, Arindam Dasgupta, Mohsen Rajabi Abhari, Akiko Ishii-Watabe, Yoshiro Saito, Dulcyane Neiva Mendes Fernandes, Joseph Bower, Chris Burns, Kevin Carleton, Seongeun (Julia) Cho, Xiulian Du, Marianne Fjording, Fabio Garofolo, Sumit Kar, Olga Kavetska, Elham Kossary, Yang Lu, Andrew Mayer, Nisha Palackal, Danielle Salha, Eric Thomas, Tom Verhaeghe, Stephen Vinter, Katty Wan, Yow-Ming Wang, Kathi Williams, Eric Woolf, Li Yang, Eric Yang, Abbas Bandukwala, Shirley Hopper, Kevin Maher, Joshua Xu, Eric Brodsky, Isabelle Cludts, Chad Irwin, Julie Joseph, Susan Kirshner, Mohanraj Manangeeswaran, Kimberly Maxfield, Joao Pedras-Vasconcelos, Therese Solstad, Seth Thacker, Omar Tounekti, Daniela Verthelyi, Meenu Wadhwa, Leslie Wagner, Takenori Yamamoto, Lucia Zhang & Lin Zhou. (2023) 2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs (Part 1A – Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization Part 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine). Bioanalysis 15:16, pages 955-1016.
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Giane Sumner, Steve Keller, James Huleatt, Roland F Staack, Leslie Wagner, Mitra Azadeh, Abbas Bandukwala, Liching Cao, Xiulian Du, Gabriela Franco Salinas, Fabio Garofolo, Shannon Harris, Shirley Hopper, Chad Irwin, Qin Ji, Julie Joseph, Lindsay King, Arvind Kinhikar, Yang Lu, Rosa Luo, Omar Mabrouk, Ludovic Malvaux, Jean-Claude Marshall, Kristina McGuire, Vincent Mikol, Robert Neely, Xiazi Qiu, Yoshiro Saito, Bruno Salaun, Ingrid Scully, John Smeraglia, Therese Solstad, Jeroen Stoop, Huaping Tang, Priscila Teixeira, Yixin Wang, Mike Wright, Luis Mendez, Chris Beaver, Jacqueline Eacret, Amelia Au-Yeung, Vilma Decman, Francis Dessy, Steven Eck, Polina Goihberg, Enrique Gomez Alcaide, Christele Gonneau, Katharine Grugan, Michael Nathan Hedrick, Sumit Kar, Sarita Sehra, Erin Stevens, Chad Stevens, Yongliang Sun, Fred McCush, LaKenya Williams, Sally Fischer, Bonnie Wu, Gregor Jordan, Chris Burns, Isabelle Cludts, Kelly Coble, Christine Grimaldi, Neil Henderson, Alison Joyce, Gregor Lotz, Yanmei Lu, Linlin Luo, Florian Neff, Gizette Sperinde, Kay-Gunnar Stubenrauch, Yuting Wang, Mark Ware & Weifeng Xu. (2023) 2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles Part 2 – Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization. Bioanalysis 15:15, pages 861-903.
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Allena Ji Ji, Guangxin Xu, Lin Tao, Hongqin Jenny Jiao & Rachel Elisabeth Palmer. (2022) Criteria of Slope and Endogenous Level for Selection of Matrix in the Quantitation of Endogenous Compounds by LC-MS/MS. Bioanalysis 14:11, pages 807-816.
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