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2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

by Piccoli, Steven, Mehta, Devangi, Vitaliti, Alessandra, Allinson, John, Amur, Shashi, Eck, Steve, Green, Cherie, Hedrick, Michael, Hopper, Shirley, Ji, Allena, Joyce, Alison, Litwin, Virginia, Maher, Kevin, Mathews, Joel, Peng, Kun, Safavi, Afshin, Wang, Yow-Ming, Zhang, Yan, Amaravadi, Lakshmi, Palackal, Nisha, Thankamony, Sai, Beaver, Chris, Bame, Eris, Emrich, Thomas, Grimaldi, Christine, Haulenbeek, Jonathan, Kakkanaiah, Vellalore, Lanham, David, Mayer, Andrew, Trampont, Paul C, Vermet, Laurent, Dakappagari, Naveen, Fleener, Catherine, Garofolo, Fabio, Rogers, Cynthia, Tangri, Shabnam, Xu, Yuanxin, Liang, Meina, Rajadhyaksha, Manoj, Richards, Susan, Schweighardt, Becky, Purushothama, Shobha, Baltrukonis, Daniel, Brumm, Jochen, Cherry, Elana, Delcarpini, Jason, Gleason, Carol, Kirshner, Susan, Kubiak, Robert, Pan, Luying, Partridge, Michael, Pedras-Vasconcelos, João, Qu, Qiang, Skibeli, Venke, Saunders, Therese Solstad, Staack, Roland F, Stubenrauch, Kay, Torri, Al, Verthelyi, Daniela, Yan, Haoheng, Gorovits, Boris, Palmer, Rachel, Milton, Mark, Long, Brian, Corsaro, Bart, Farrokhi, Vahid, Fiscella, Michele, Henderson, Neil, Jawa, Vibha, McNally, Jim, Murphy, Rocio, Waldner, Hanspeter, Yang, Tong-Yuan
Published in Bioanalysis (01.12.2019)

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