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Analytical comparability study of recombinant monoclonal antibody therapeutics.
Ambrogelly, Alexandre; Gozo, Stephen; Katiyar, Amit; Dellatore, Shara; Kune, Yune; Bhat, Ram; Sun, Joanne; Li, Ning; Wang, Dongdong; Nowak, Christine; Neill, Alyssa; Ponniah, Gomathinayagam; King, Cory; Mason, Bruce; Beck, Alain; Liu, Hongcheng.
Afiliación
  • Ambrogelly A; a Biologics Analytical Operations, Pharmaceutical & Biologics Development, Gilead Sciences , Ocean Ranch Blvd, Oceanside , CA.
  • Gozo S; b Analytical Research & Development-Biologics, Celgene Corporation , Morris Avenue, Summit , NJ.
  • Katiyar A; c Analytical Development, Bristol-Myers Squibb , Pennington Rocky Road, Pennington , NJ.
  • Dellatore S; d Biologics & Vaccines Bioanalytics, MRL, Merck & Co., Inc. , Galloping Hill Road, Kenilworth , NJ USA.
  • Kune Y; e Fortress Biologicals , Sawyer Road, Suite, Waltham , MA.
  • Bhat R; f Millennium Research laboratories , New Boston Street, Woburn , MA.
  • Sun J; g Product Development, Innovent Biologics , Dongping Street, Suzhou Industrial Park , China.
  • Li N; h Analytical Chemistry, Regeneron Pharmaceuticals, Inc. , Old Saw Mill River Road, Tarrytown , NY.
  • Wang D; i Analytical Department , BioAnalytix, Inc. , Memorial Drive, Cambridge , MA.
  • Nowak C; j Product Characterization, Alexion Pharmaceuticals , College Street, New Haven , CT.
  • Neill A; j Product Characterization, Alexion Pharmaceuticals , College Street, New Haven , CT.
  • Ponniah G; j Product Characterization, Alexion Pharmaceuticals , College Street, New Haven , CT.
  • King C; j Product Characterization, Alexion Pharmaceuticals , College Street, New Haven , CT.
  • Mason B; k Pre-formulation, Alexion Pharmaceuticals , College Street, New Haven , CT.
  • Beck A; l Analytical Chemistry, NBEs, Center d'Immunologie Pierre Fabre , St Julien-en-Genevois Cedex , France.
  • Liu H; j Product Characterization, Alexion Pharmaceuticals , College Street, New Haven , CT.
MAbs ; 10(4): 513-538, 2018.
Article en En | MEDLINE | ID: mdl-29513619
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Garantía de la Calidad de Atención de Salud / Proteínas Recombinantes / Química Farmacéutica / Anticuerpos Monoclonales Límite: Humans Idioma: En Revista: MAbs Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Garantía de la Calidad de Atención de Salud / Proteínas Recombinantes / Química Farmacéutica / Anticuerpos Monoclonales Límite: Humans Idioma: En Revista: MAbs Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2018 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Estados Unidos