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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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2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays)

by Stevenson, Lauren, Richards, Susan, Pillutla, Renuka, Torri, Albert, Kamerud, John, Mehta, Devangi, Keller, Stephen, Purushothama, Shobha, Gorovits, Boris, Litwin, Virginia, Stebbins, Christopher, Marini, Joseph, Beaver, Chris, Sperinde, Gizette, Siguenza, Patricia, Staack, Roland F, Qiu, Yongchang, Amaravadi, Lakshmi, Amur, Shashi, Fleener, Catherine Aversa, Baltrukonis, Daniel, Catlett, Ian, Cherry, Elana, Chung, Shan, Cludts, Isabelle, Donato, Lorella Di, Fischer, Saloumeh, Fraser, Stephanie, Garofolo, Fabio, Green, Cherie, Gunn, George, Haidar, Sam, Haulenbeek, Jonathan, Henderson, Neil, Hopper, Shirley, Ishii-Watabe, Akiko, Islam, Rafiq, Janelsins, Brian, Jawa, Vibha, Kakkanaiah, Vellalore, Kamondi, Szilard, Kolaitis, Gerry, Kubiak, Robert J, Kumar, Seema, Kurki, Pekka, Liang, Meina, Liu, Patrick, Maxfield, Kimberly, Myler, Heather, Palackal, Nisha, Palmer, Rachel, Pedras-Vasconcelos, João, Piccoli, Steven, Rhyne, Paul, Saito, Yoshiro, Savoie, Natasha, Schick, Eginhard, Schweighardt, Becky, Shih, Judy, Song, An, Sriraman, Priya, Staelens, Ludovicus, Sumner, Giane, Sun, Yongliang, Ullmann, Martin, Verthelyi, Daniela, Wadhwa, Meenu, Wang, Yow-Ming, Xu, Yuanxin, Yan, Haoheng, Yang, Tong-yuan, Zeng, Rong
Published in Bioanalysis (01.12.2018)

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