Expectations for Phase-Appropriate Drug Substance and Drug Product Specifications for Early-Stage Protein Therapeutics.

Kretsinger, Juliana; Frantz, Neha; Hart, Scott A; Kelley, Wayne P; Kitchen, Bob; Novick, Shawn; Rellahan, Barbara; Stranges, Daniela; Stroop, Corné J M; Yin, Ping; Gastens, Martin H

Kretsinger, Juliana; Frantz, Neha; Hart, Scott A; Kelley, Wayne P; Kitchen, Bob; Novick, Shawn; Rellahan, Barbara; Stranges, Daniela; Stroop, Corné J M; Yin, Ping; Gastens, Martin H.

Afiliación

Kretsinger J; Bioproduct Analytical Development, Eli Lilly and Company, Indianapolis, Indiana 46285. Electronic address: kretsinger_juliana_kay@lilly.com.
Frantz N; Biogen, Research Triangle Park, North Carolina 27709.
Hart SA; Product Development, Bristol-Myers Squibb, New Brunswick, New Jersey 08903.
Kelley WP; Biopharmaceutical Development and Supply, GlaxoSmithKline, King of Prussia, Pennsylvania 19406.
Kitchen B; Pfizer Inc., Andover, Massachusetts 01810.
Novick S; Seattle Genetics, Bothell, Washington 98021.
Rellahan B; Amgen, Homer Building, Washington, District of Columbia 20005.
Stranges D; Technical Research and Development, GSK Vaccines srl, 53100, Siena, Italy.
Stroop CJM; Biologics and Vaccines Analytics, MSD, Oss, the Netherlands.
Yin P; Analytical Development, Vertex Pharmaceuticals, Boston, Massachusetts 02210.
Gastens MH; NBE Development, AbbVie Inc., North Chicago, Illinois 60064. Electronic address: martin.gastens@abbvie.com.

J Pharm Sci ; 108(4): 1442-1452, 2019 04.

Article en En | MEDLINE | ID: mdl-30528942

Asunto(s)

Anticuerpos Monoclonales/química; Ensayos Clínicos Fase I como Asunto/normas; Desarrollo de Medicamentos/normas; Inmunoconjugados/química; Tecnología Farmacéutica/normas; Industria Farmacéutica/normas; Industria Farmacéutica/estadística & datos numéricos; Humanos; Control de Calidad; Medición de Riesgo; Encuestas y Cuestionarios/estadística & datos numéricos

Palabras clave

analytical chemistry; antibody drug conjugate(s) (ADC); antibody drug(s); degradation product(s); drug-like property(s); monoclonal antibody(s); physicochemical properties; protein aggregation

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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Tecnología Farmacéutica / Ensayos Clínicos Fase I como Asunto / Inmunoconjugados / Desarrollo de Medicamentos / Anticuerpos Monoclonales Tipo de estudio: Clinical_trials / Etiology_studies / Guideline / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: J Pharm Sci Año: 2019 Tipo del documento: Article

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