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An Industry Perspective on Forced Degradation Studies of Biopharmaceuticals: Survey Outcome and Recommendations.
Halley, Jennifer; Chou, Yite Robert; Cicchino, Crystal; Huang, Min; Sharma, Vikas; Tan, Niclas Chiang; Thakkar, Santosh; Zhou, Liqiang Lisa; Al-Azzam, Wasfi; Cornen, Stephane; Gauden, Magdalena; Gu, Zhenyu; Kar, Sambit; Lazar, Alexandru C; Mehndiratta, Promod; Smith, John; Sosic, Zoran; Weisbach, Paul; Stokes, Elaine S E.
Afiliación
  • Halley J; UCB, Biomolecular Characterisation Sciences, 216 Bath Road, Slough, Berkshire SL1 3WE, UK. Electronic address: Jennifer.Halley@ucb.com.
  • Chou YR; Merck & Co. Inc., Analytical Research & Development, K-15 B419c, 2000 Galloping Hill Road, Kenilworth, New Jersey 070330.
  • Cicchino C; Regeneron, 81 Columbia Turnpike, Rensselaer, New York 12144.
  • Huang M; Pfizer, BTx Pharm Sci Pharmaceutical R&D, 1 Burtt Road, Andover, Massachusetts 01810.
  • Sharma V; Genentech, A Member of Roche Group, 1 DNA Way, South San Francisco, California 94080.
  • Tan NC; Takeda Pharmaceuticals International Co., 300 Massachusetts Avenue, Cambridge, Massachusetts 02139.
  • Thakkar S; Janssen Research & Development, Large Molecule Drug Product Development, 200 Great Valley Parkway, Malvern, Pennsylvania 19355.
  • Zhou LL; AbbVie Bioresearch Center, 100 Research Dr, Worcester, Massachusetts 01605.
  • Al-Azzam W; GlaxoSmithKline R&D, 1250 S. Collegeville Road, Collegeville, Pennsylvania 19426.
  • Cornen S; Sanofi, Biologics Development, 13, Quai Jules Guesde - BP 14, 94403 Vitry-sur-Seine Cedex, France.
  • Gauden M; Lonza Biologics, 228 Bath Road, Slough, SL1 4DX, UK.
  • Gu Z; Alexion Pharmaceuticals, 100 College St., New Haven, Connecticut 06510.
  • Kar S; Bristol-Myers Squibb, Molecular and Analytical Development, 311 Pennington-Rocky Hill Road, Pennington, New Jersey 08534.
  • Lazar AC; ImmunoGen, Inc., Analytical and Pharmaceutical Development, 830 Winter Street, Waltham, Massachusetts 02451.
  • Mehndiratta P; Celgene, Analytical Development, 556 Morris Ave, Summit, New Jersey 07901.
  • Smith J; Lonza Biologics, 228 Bath Road, Slough, SL1 4DX, UK.
  • Sosic Z; Biogen, Analytical Development, Cambridge, Massachusetts 02142.
  • Weisbach P; ImmunoGen, Inc., Analytical and Pharmaceutical Development, 830 Winter Street, Waltham, Massachusetts 02451.
  • Stokes ESE; BioPhorum Operations Group, Sharrow Vale Road, Sheffield, S11 8YZ, UK.
J Pharm Sci ; 109(1): 6-21, 2020 01.
Article en En | MEDLINE | ID: mdl-31563512
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Química Farmacéutica / Encuestas y Cuestionarios / Industria Farmacéutica / Desarrollo de Medicamentos / Anticuerpos Monoclonales Tipo de estudio: Prognostic_studies / Qualitative_research Límite: Humans Idioma: En Revista: J Pharm Sci Año: 2020 Tipo del documento: Article
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Productos Biológicos / Química Farmacéutica / Encuestas y Cuestionarios / Industria Farmacéutica / Desarrollo de Medicamentos / Anticuerpos Monoclonales Tipo de estudio: Prognostic_studies / Qualitative_research Límite: Humans Idioma: En Revista: J Pharm Sci Año: 2020 Tipo del documento: Article