换一批2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation (Part 3-Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays)
第一作者：
Corsaro, Bart
作者：
Corsaro, Bart [1]
;
Yang, Tong-yuan [2]
;
Murphy, Rocio [3]
;
Sonderegger, Ivo [4]
;
Exley, Andrew [5]
;
Bertholet, Sylvie [6]
;
Dakappagari, Naveen [7]
;
Dessy, Francis [8]
;
Garofolo, Fabio [9]
;
Kierstead, Lisa [10]
;
Koch, Holger [11]
;
Sarikonda, Ghanashyam [12]
;
Savoie, Natasha [13]
;
Siggers, Richard [14]
;
Solstad, Therese [15]
;
Lu, Yanmei [16]
;
Milton, Mark [17]
;
Marshall, Jean-Claude [18]
;
DelCarpini, Jason [19]
;
Gorovits, Boris [20]
;
Gupta, Swati [21]
;
Jesaitis, Lynne [22]
;
Kamerud, John [23]
;
Kromminga, Arno [24]
;
Ma, Anna [25]
;
McNally, Jim [26]
;
Yan, Haoheng [27]
;
Wu, Bonnie [28]
;
Verthelyi, Daniela [29]
;
Kirshner, Susan [30]
;
Pedras-Vasconcelos, Joao [31]
;
Rajadhyaksha, Manoj [32]
;
Staack, Roland F. [33]
;
Cherry, Elana [34]
;
Cludts, Isabelle [35]
;
Dahlback, Madeleine [36]
;
Gunn, George R. [37]
;
Ishii-Watabe, Akiko [38]
;
Jawa, Vibha ;
Kubiak, Robert ;
Partridge, Michael ;
Petrillo, Marco ;
Pine, Samuel O. ;
Poetzl, Johann ;
Song, Sam ;
Stebbins, Chris ;
Wu, Yuling ;
Zhang, Lucia ;
Kar, Sumit ;
Liang, Meina ;
Abhari, Mohsen Rajabi ;
Schweighardt, Becky ;
Stubenrauch, Kay ;
Xu, Yuanxin
作者单位：
Regeneron Pharmaceut, Tarrytown, NY USA
[1]
BioAgilytix, Hamburg, Germany
[2]
Norwegian Med Agcy, Oslo, Norway
[3]
Pfizer, Groton, CT USA
[4]
GlaxoSmithKline, Collegeville, PA USA
[5]
PPD, Wayne, PA USA
[6]
GlaxoSmithKline, Rixensart, Belgium
[7]
Hlth Canada, Ottawa, ON, Canada
[8]
BioAgilytix, Durham, NC USA
[9]
CRISPR Therapeut, Cambridge, MA USA
[10]
UK MHRA NIBSC, London, England
[11]
BioMarin, Novato, CA USA
[12]
Novo Nordisk, Malov, Denmark
[13]
CFABS, Montreal, PQ, Canada
[14]
GlaxoSmithKline, Rockville, MD USA
[15]
US FDA, Silver Spring, MD USA
[16]
AstraZeneca, Gaithersburg, MD USA
[17]
Takeda, Opfikon, Switzerland
[18]
bluebird bio, Cambridge, MA USA
[19]
Navigate, San Diego, CA USA
[20]
Ablynx, Zwijnaarde, Belgium
[21]
Novartis, Cambridge, MA USA
[22]
Immunologix Labs, Tampa, FL USA
[23]
Janssen R&D, Spring House, PA USA
[24]
AbbVie, Irvine, CA USA
[25]
Pfizer, Andover, MA USA
[26]
Takeda, Cambridge, MA USA
[27]
BRI, Vancouver, BC, Canada
[28]
Sangamo Therapeut, Brisbane, CA USA
[29]
Hexal AG, Oberhaching, Germany
[30]
Merck, West Point, PA USA
[31]
UK MHRA, London, England
[32]
Biogen, Cambridge, MA USA
[33]
Intellia Therapeut, Cambridge, MA USA
[34]
Roche Innovat Ctr, Roche Pharma Res & Early Dev, Munich, Germany
[35]
Japan MHLW NIHS, Tokyo, Japan
[36]
Merck, Kenilworth, NJ USA
[37]
AstraZeneca, San Francisco, CA USA
[38]
发布时间
2021-08-19
- 浏览3
Bioanalysis
Bioanalysis
415-463页
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