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Best practices in bioassay development to support registration of biopharmaceuticals.
White, John R; Abodeely, Marla; Ahmed, Sammina; Debauve, Gaël; Johnson, Evan; Meyer, Debra M; Mozier, Ned M; Naumer, Matthias; Pepe, Alessandra; Qahwash, Isam; Rocnik, Edward; Smith, Jeffrey G; Stokes, Elaine Se; Talbot, Jeffrey J; Wong, Pin Yee.
Afiliação
  • White JR; Biopharmaceutical Development GlaxoSmithKline R&D, 1250 S Collegeville Rd, Collegeville, PA 19426, USA.
  • Abodeely M; Analytical Development Department, Shire, 200 Shire Way, Lexington, MA 02421, USA.
  • Ahmed S; Analytical Services, Lonza Biologics plc, 228 Bath Rd, Slough, SL1 4DX, UK.
  • Debauve G; Bioassay Development, Analytical Development Sciences for Biologicals, UCB Pharma, Chemin du Foriest, B-1420 Braine-l'Alleud, Belgium.
  • Johnson E; Analytical Development - Biologics, Takeda Pharmaceuticals International Co., 300 Massachusetts Ave, Cambridge, MA 02139, USA.
  • Meyer DM; Biotherapeutics Pharmaceutical Sciences, Pfizer Inc, 700 Chesterfield Parkway West, Chesterfield, MO 63017, USA.
  • Mozier NM; Biotherapeutics Pharmaceutical Sciences, Pfizer Inc, 700 Chesterfield Parkway West, Chesterfield, MO 63017, USA.
  • Naumer M; NBE Analytical R&D, AbbVie Deutschland GmbH & Co. KG, Knollstrasse, Ludwigshafen 67061, Germany.
  • Pepe A; Analytical Development Biotech department, Merck Serono SpA, 11 Via Luigi Einaudi, Guidonia Montecelio (RM), 00012, Italy.
  • Qahwash I; Biologics Development, Molecular & Analytical Development, Bristol-Myers Squibb, 311 Pennington-Rocky Hill Road, Pennington, NJ 08534, USA.
  • Rocnik E; Analytical Development - Biologics, Takeda Pharmaceuticals International Co., 300 Massachusetts Ave, Cambridge, MA 02139, USA.
  • Smith JG; Analytical R&D, Pfizer Inc., 1 Burtt Road, Andover, MA 01810, USA.
  • Stokes ES; Development Group, BioPhorum Operations Group, The Gridiron building, 1 Pancras Square, London, N1C 4AG, UK.
  • Talbot JJ; Analytical Sciences, Regeneron Pharmaceuticals Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA.
  • Wong PY; Analytical Development and Quality Control, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
Biotechniques ; 67(3): 126-137, 2019 09.
Article em En | MEDLINE | ID: mdl-31379198
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Guideline / Prognostic_studies Limite: Animals / Humans Idioma: En Revista: Biotechniques Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Produtos Biológicos / Avaliação Pré-Clínica de Medicamentos Tipo de estudo: Guideline / Prognostic_studies Limite: Animals / Humans Idioma: En Revista: Biotechniques Ano de publicação: 2019 Tipo de documento: Article País de afiliação: Estados Unidos