未登录 2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A-Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B-Regulatory Agencies' Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV)) 2025年生物分析近期问题白皮书：生物标志物校准与稳定性；NULISA评估；神经丝蛋白与自身抗体生物标志物检测；去除IgM干扰；ELISpot与FluoroSpot最佳实践；模块化高维度细胞计数；单细胞分析成像细胞计数（第二部分A-关于生物标志物发现、开发、验证与监管批准、配体结合检测（LBA）和细胞基础检测（CBA）的建议；第二部分B-监管机构对生物标志物、体外诊断（IVD）/伴随诊断（CDx）和生物标志物检测验证（BAV）的反馈） Hersey, Sarah; McGuire, Kristina; Kholmanskikh, Olga; Bivi, Nicoletta; Bandukwala, Abbas; Gong, Binsheng; Irwin, Chad; Ray, Soma; Gunsior, Michele; Avanesov, Andrei; Baker, Brian; Bond, Sarah; Braun, Alexander; Buoninfante, Alessandra; Dessy, Francis; Fang, Xiaodong; Garofolo, Fabio; Gomme, Emily; Hays, Amanda; King, Lindsay; Mayer, Christian; McGregor, Jessica; McHenry, Melis; Nowocin, Anna; Rubel, Carrie; Sanderink, Gerard; Scott, Bradley; Scully, Ingrid; Seyda, Agnes; Stoop, Jeroen; Tang, Huaping; Tavares Neto, Joao; Walravens, Karl; Wang, Kai; Wassmer, Sarah; Xiao, Wenming; Zhu, Liang; Zoghbi, Jad; Brockus, Catherine; Petit-Frere, Corinne; Coble, Kelly; Fischer, Sally; Yearwood, Graham; Cao, Liching; Dysinger, Mark; Grimaldi, Christine; Jiang, Yong; Joyce, Alison; Kerridge, Claire; Lu, Kun; McCush, Fred; Nolan, Katrina; O'Connor, Ellen; Palmer, Rachel; Reese, Kimberly; Stubenrauch, Kay-Gunnar; Verch, Thorsten; Beaver, Christopher; Mendez, Luis; Decman, Vilma; Bhavaraju, Kamala; Huleatt, James; Trampont, Paul C.; Eck, Steven; Goihberg, Polina; Alcaide, Enrique Gomez; Hedrick, Michael Nathan; Jalah, Rashmi; McGrath, Shannon; Ogorman, William; Prior, Sandra; Sehra, Sarita; Shaik, Saleem; Standifer, Nathan; Stevens, Chad; Stevens, Erin; Sun, Yongliang (Steve) 分享 收藏
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Best Practices and Recommendations for Non-Liquid Matrices Bioanalysis Vazvaei-Smith, Faye; Li, Wenkui; Barnaby, Omar S.; Bhardwaj, Sanjeev; Dong, Juyao; Dumont, Carolyne; Fernandez-Metzler, Carmen; Geist, Brian; Hassanein, Mohamed; Hays, Amanda; Ilinskaya, Anna; Kadar, Eugene P.; King, Kris; Kulagina, Nadia; Matta, Murali K.; Midde, Krishna; Pan, Rina; Pathania, Divya; Tarnowski, Thomas; Tewalt, Eric; Thomas, Eric; Wickremsinhe, Enaksha; Xiao, Deqing 分享 收藏
Neutralizing Antibody Sample Testing and Report Harmonization (vol 26, 80, 2024) Jani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; Delcarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin 分享 收藏
Neutralizing Antibody Sample Testing and Report Harmonization Jani, Darshana; Gunsior, Michele; Marsden, Robin; Cowan, Kyra J.; Irvin, Susan C.; Hay, Laura Schild; Ward, Bethany; Armstrong, Luke; Azadeh, Mitra; Cao, Liching; Carmean, Rebecca; DelCarpini, Jason; Dholakiya, Sanjay L.; Hays, Amanda; Hosback, Sarah; Hu, Zheng; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lichtfuss, Marit; Liu, Hsing-Yin; Liu, Susana; Mozaffari, Reza; Pan, Luying; Pennucci, Jason; Poupart, Marie-Eve; Saini, Gurleen; Snoeck, Veerle; Storey, Kristine; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Wala, Iwona; Yang, Lili; Yang, Lin 分享 收藏
Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development Hays, Amanda; Wissel, Mark; Colletti, Kelly; Soon, Russell; Azadeh, Mitra; Smith, Justin; Doddareddy, Rajitha; Chalfant, Melanie; Adamowicz, Wendy; Ramaswamy, Swarna Suba; Dholakiya, Sanjay L.; Guelman, Sebastian; Gullick, Bryan; Durham, Jennifer; Rennier, Keith; Nagilla, Pruthvi; Muruganandham, Anamica; Diaz, Manisha; Tierney, Cassandra; John, Kaarthik; Valentine, Jenny; Lockman, Timothy; Liu, Hsing-Yin; Moritz, Benjamin; Ouedraogo, Jean Paul; Piche, Marie-Soleil; Smet, Muriel; Murphy, Jacqueline; Koenig, Kaylyn; Zybura, Agnes; Vyhlidal, Carrie; Mercier, Jonathan; Jani, Niketa; Kubista, Mikael; Birch, Donald; Morse, Karlin; Johansson, Oskar 分享 收藏
Validation of Anti-Adeno Associated Virus Serotype rh10 (AAVrh.10) Total and Neutralizing Antibody Immunogenicity Assays Butala-Flores, Elizabeth; Nguyen, Thien; Selvan, Nithya; Armstrong, Luke; Miller, Michelle; Kamen, Lynn; Lester, Todd; Wernyj, Roman; Khanna, Richie; Mcnally, Jim; Hays, Amanda 分享 收藏
Neutralizing Antibody Validation Testing and Reporting Harmonization Myler, Heather; Pedras-Vasconcelos, Joao; Lester, Todd; Civoli, Francesca; Xu, Weifeng; Wu, Bonnie; Vainshtein, Inna; Luo, Linlin; Hassanein, Mohamed; Liu, Susana; Ramaswamy, Swarna Suba; Mora, Johanna; Pennucci, Jason; McCush, Fred; Lavelle, Amy; Jani, Darshana; Ambakhutwala, Angela; Baltrukonis, Daniel; Barker, Breann; Carmean, Rebecca; Chung, Shan; Dai, Sheng; DeWall, Stephen; Dholakiya, Sanjay L.; Dodge, Robert; Finco, Deborah; Yan, Haoheng; Hays, Amanda; Hu, Zheng; Inzano, Cynthia; Kamen, Lynn; Lai, Ching-Ha; Meyer, Erik; Nelson, Robert; Paudel, Amrit; Phillips, Kelli; Poupart, Marie-Eve; Qu, Qiang; Abhari, Mohsen Rajabi; Ryding, Janka; Sheldon, Curtis; Spriggs, Franklin; Warrino, Dominic; Wu, Yuling; Yang, Lin; Pasas-Farmer, Stephanie 分享 收藏
Anti-drug Antibody Sample Testing and Reporting Harmonization Jani, Darshana; Marsden, Robin; Gunsior, Michele; Hay, Laura Schild; Ward, Bethany; Cowan, Kyra J.; Azadeh, Mitra; Barker, Breann; Cao, Liching; Closson, Kristin R.; Coble, Kelly; Dholakiya, Sanjay L.; Dusseault, Julie; Hays, Amanda; Herl, Carina; Hodsdon, Michael E.; Irvin, Susan C.; Kirshner, Susan; Kolaitis, Gerry; Kulagina, Nadia; Kumar, Seema; Lai, Ching Ha; Lipari, Francesco; Liu, Susana; Merdek, Keith D.; Moldovan, Ioana R.; Mozaffari, Reza; Pan, Luying; Place, Corina; Snoeck, Veerle; Manning, Marta Starcevic; Stocker, Dennis; Tary-Lehmann, Magdalena; Turner, Amy; Vainshtein, Inna; Verthelyi, Daniela; Williams, William T.; Yan, Haoheng; Yan, Weili; Yang, Lili; Yang, Lin; Zemo, Jennifer; Zhong, Zhandong Don 分享 收藏
Is Incurred Sample Reanalysis (ISR) Applicable in Biomarker Assays? Hays, Amanda; Amaravadi, Lakshmi; Fernandez-Metzler, Carmen; King, Lindsay; Mathews, Joel; Ni, Yan; Quadrini, Karen; Tinder, Chunyan; Vazvaei, Faye; Zeng, Jianing 分享 收藏
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AAPS Perspective on the EURL Recommendation on the use of Non-Animal-Derived Antibodies Gorovits, B.; Hays, A.; Jani, D.; Jones, C.; King, C.; Lundequist, A.; Mora, J.; Partridge, M.; Pathania, D.; Ramaswamy, S. S.; Rutwij, D.; Shen, H.; Starling, G. 分享 收藏
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