换一批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 <u>Part 2</u> - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
第一作者：
Giane,Sumner
第一单位：
Regeneron, Tarrytown, NY, USA.
作者：
Giane,Sumner [1]
;
Steve,Keller [2]
;
James,Huleatt [3]
;
Roland F,Staack [4]
;
Leslie,Wagner [5]
;
Mitra,Azadeh [6]
;
Abbas,Bandukwala [5]
;
Liching,Cao [7]
;
Xiulian,Du [5]
;
Gabriela Franco,Salinas [8]
;
Fabio,Garofolo [9]
;
Shannon,Harris [10]
;
Shirley,Hopper [11]
;
Chad,Irwin [12]
;
Qin,Ji [13]
;
Julie,Joseph [12]
;
Lindsay,King [14]
;
Arvind,Kinhikar [15]
;
Yang,Lu [5]
;
Rosa,Luo [16]
;
Omar,Mabrouk [17]
;
Ludovic,Malvaux [18]
;
Jean-Claude,Marshall [19]
;
Kristina,McGuire [1]
;
Vincent,Mikol [20]
;
Robert,Neely [21]
;
Xiazi,Qiu [22]
;
Yoshiro,Saito [23]
;
Bruno,Salaun [18]
;
Ingrid,Scully [24]
;
John,Smeraglia [25]
;
Therese,Solstad [26]
;
Jeroen,Stoop [8]
;
Huaping,Tang [27]
;
Priscila,Teixeira [4]
;
Yixin,Wang [21]
;
Mike,Wright [28]
;
Luis,Mendez [29]
;
Chris,Beaver [30]
;
Jacqueline,Eacret [31]
;
Amelia,Au-Yeung [32]
;
Vilma,Decman [33]
;
Francis,Dessy [18]
;
Steven,Eck [34]
;
Polina,Goihberg [35]
;
Enrique Gomez,Alcaide [4]
;
Christele,Gonneau [36]
;
Katharine,Grugan [37]
;
Michael Nathan,Hedrick [21]
;
Sumit,Kar [22]
;
Sarita,Sehra [38]
;
Erin,Stevens [39]
;
Chad,Stevens [35]
;
Yongliang,Sun [21]
;
Fred,McCush [39]
;
LaKenya,Williams [21]
;
Sally,Fischer [32]
;
Bonnie,Wu [37]
;
Gregor,Jordan [4]
;
Chris,Burns [11]
;
Isabelle,Cludts [11]
;
Kelly,Coble [40]
;
Christine,Grimaldi [1]
;
Neil,Henderson [41]
;
Alison,Joyce [42]
;
Gregor,Lotz [4]
;
Yanmei,Lu [7]
;
Linlin,Luo [31]
;
Florian,Neff [4]
;
Gizette,Sperinde [32]
;
Kay-Gunnar,Stubenrauch [4]
;
Yuting,Wang [22]
;
Mark,Ware [37]
;
Weifeng,Xu [31]
作者单位：
Regeneron, Tarrytown, NY, USA.
[1]
AbbVie, South San Francisco, CA, USA.
[2]
Sanofi Pasteur, Swiftwater, PA, USA.
[3]
Roche Pharma Research & Early Development, Roche Innovation Center, Munich, Germany.
[4]
US FDA, Silver Spring, MD, USA.
[5]
Alkermes, Waltham, MA, USA.
[6]
Sangamo, Brisbane, CA, USA.
[7]
Janssen, Leiden, South Holland, Netherlands.
[8]
BRI Frontage, Vancouver, BC, Canada.
[9]
HilleVax, Cambridge, MA, USA.
[10]
UK MHRA, London, UK.
[11]
Health Canada, Ottawa, ON, Canada.
[12]
AbbVie, North Chicago, IL, USA.
[13]
Pfizer, Cambridge, MA, USA.
[14]
Novartis, Cambridge, MA, USA.
[15]
Crinetics, San Diego, CA, USA.
[16]
Biogen, Cambridge, MA, USA.
[17]
GSK Vaccines, Rixensart, Belgium.
[18]
Moderna, Cambridge, MA, USA.
[19]
Sanofi, Vitry-sur-Seine, France.
[20]
Bristol-Myers Squibb, Lawrenceville, NJ, USA.
[21]
WRIB, Montreal, QC, Canada.
[22]
Japan MHLW, Tokyo, Japan.
[23]
Pfizer, Pearl River, NY, USA.
[24]
UCB, Braine-l'Alleud, Wallonia, Belgium.
[25]
Norway NoMA, Oslo, Norway.
[26]
GlaxoSmithKline, Collegeville, PA, USA.
[27]
GlaxoSmithKline, Stevenage, UK.
[28]
Merck, Kenilworth, NJ, USA.
[29]
Syneos Health, Toronto, ON, Canada.
[30]
Merck, West Point, PA, USA.
[31]
Genentech, South San Francisco, CA, USA.
[32]
GlaxoSmithKline, Philadelphia, PA, USA.
[33]
AstraZeneca, Gaithersburg, MD, USA.
[34]
Pfizer, Andover, MA, USA.
[35]
Labcorp, Meyrin, Switzerland.
[36]
Janssen R&D, Spring House, Pa, USA.
[37]
Incyte, Wilmington, DE, USA.
[38]
Pfizer, Groton, CT, USA.
[39]
Boehringer Ingelheim, Ridgefield, CT, USA.
[40]
Integrated Bioanalysis, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
[41]
Pfizer, Groveland, MA, USA.
[42]
DOI
10.4155/bio-2023-0151
PMID
37584363
发布时间
2025-12-12
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Bioanalysis
Bioanalysis
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