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2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
Neubert, Hendrik; Song, An; Lee, Anita; Wei, Cong; Duggan, Jeff; Xu, Keyang; Woolf, Eric; Evans, Chris; Palandra, Joe; Laterza, Omar; Amur, Shashi; Berger, Isabella; Bustard, Mark; Cancilla, Mark; Chen, Shang-Chiung; Cho, Seongeun Julia; Ciccimaro, Eugene; Cludts, Isabelle; Cocea, Laurent; D'Arienzo, Celia; Danan-Leon, Lieza; Donato, Lorella Di; Garofolo, Fabio; Haidar, Sam; Ishii-Watabe, Akiko; Jiang, Hao; Kadavil, John; Kassim, Sean; Kurki, Pekka; Blaye, Olivier Le; Liu, Kai; Mathews, Rod; Lima Santos, Gustavo Mendes; Niwa, Makoto; Pedras-Vasconcelos, João; Qian, Mark; Rago, Brian; Saad, Ola; Saito, Yoshiro; Savoie, Natasha; Su, Dian; Szapacs, Matthew; Tampal, Nilufer; Vinter, Stephen; Wang, Jian; Welink, Jan; Whale, Emma; Wilson, Amanda; Xue, Y-J.
Affiliation
  • Neubert H; Pfizer, Andover, MA, USA.
  • Song A; Genentech, South San Francisco, CA, USA.
  • Lee A; Merck, Kenilworth, NJ, USA.
  • Wei C; Vertex Pharmaceuticals, Boston, MA, USA.
  • Duggan J; JXD Bioanalytics, Southbury, CT, USA (previously Boehringer-Ingelheim, Ridgefield, CT, USA).
  • Xu K; Genentech, South San Francisco, CA, USA.
  • Woolf E; Merck, West Point, PA, USA.
  • Evans C; GlaxoSmithKline, King of Prussia, PA, USA.
  • Palandra J; Pfizer, Andover, MA, USA.
  • Laterza O; Merck, Kenilworth, NJ, USA.
  • Amur S; US FDA, Silver Spring, MD, USA.
  • Berger I; Austria AGES, Wien, Austria.
  • Bustard M; Health Canada, Ottawa, ON, Canada.
  • Cancilla M; Merck, West Point, PA, USA.
  • Chen SC; Genentech, South San Francisco, CA, USA.
  • Cho SJ; US FDA, Silver Spring, MD, USA.
  • Ciccimaro E; Bristol-Myers Squibb, Princeton, NJ, USA.
  • Cludts I; UK MHRA-NIBSC, London, UK.
  • Cocea L; Health Canada, Ottawa, ON, Canada.
  • D'Arienzo C; Bristol-Myers Squibb, Princeton, NJ, USA.
  • Danan-Leon L; AbbVie Stemcentrx, South San Francisco, CA, USA.
  • Donato LD; Caprion BioSciences, Montreal, QC, Canada.
  • Garofolo F; Angelini Pharma, Rome, Italy.
  • Haidar S; US FDA, Silver Spring, MD, USA.
  • Ishii-Watabe A; Japan MHLW-NIHS, Tokyo, Japan.
  • Jiang H; Bristol-Myers Squibb, Princeton, NJ, USA.
  • Kadavil J; US FDA, Silver Spring, MD, USA.
  • Kassim S; US FDA, Silver Spring, MD, USA.
  • Kurki P; Finland Fimea, Helsinki, Finland.
  • Blaye OL; France ANSM, Saint Denis, France.
  • Liu K; Regulus, San Diego, CA, USA.
  • Mathews R; Genentech, South San Francisco, CA, USA.
  • Lima Santos GM; Brazil Anvisa, Brasilia, Brazil.
  • Niwa M; Nippon Kayaku, Tokyo, Japan.
  • Pedras-Vasconcelos J; US FDA, Silver Spring, MD, USA.
  • Qian M; Takeda Pharmaceuticals, Cambridge, MA, USA.
  • Rago B; Pfizer, Groton, CT, USA.
  • Saad O; Genentech, South San Francisco, CA, USA.
  • Saito Y; Japan MHLW-NIHS, Tokyo, Japan.
  • Savoie N; CFABS, Montreal, QC, Canada.
  • Su D; Genentech, South San Francisco, CA, USA.
  • Szapacs M; GlaxoSmithKline, King of Prussia, PA, USA.
  • Tampal N; US FDA, Silver Spring, MD, USA.
  • Vinter S; UK MHRA, London, UK.
  • Wang J; Bristol-Myers Squibb, Princeton, NJ, USA.
  • Welink J; EMA, London, UK.
  • Whale E; UK MHRA, London, UK.
  • Wilson A; AstraZeneca, Cambridge, UK.
  • Xue YJ; Celgene, Summit, NJ, USA.
Bioanalysis ; 9(23): 1895-1912, 2017 Dec.
Article in En | MEDLINE | ID: mdl-29205053
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Mass Spectrometry / Biomarkers / Immunity, Active Type of study: Guideline Language: En Journal: Bioanalysis Year: 2017 Document type: Article Affiliation country:
Fulltext
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Mass Spectrometry / Biomarkers / Immunity, Active Type of study: Guideline Language: En Journal: Bioanalysis Year: 2017 Document type: Article Affiliation country: