Industry view on the relative importance of "clonality" of biopharmaceutical-producing cell lines.

Frye, Christopher; Deshpande, Rohini; Estes, Scott; Francissen, Kathy; Joly, John; Lubiniecki, Anthony; Munro, Trent; Russell, Reb; Wang, Tongtong; Anderson, Karin

Frye, Christopher; Deshpande, Rohini; Estes, Scott; Francissen, Kathy; Joly, John; Lubiniecki, Anthony; Munro, Trent; Russell, Reb; Wang, Tongtong; Anderson, Karin.

Afiliação

Frye C; Eli Lilly & Company, Indianapolis, IN 46285, United States. Electronic address: ccfrye@lilly.com.
Deshpande R; Amgen Inc, Thousand Oaks, CA, United States.
Estes S; Biogen Inc, Cambridge, MA, United States.
Francissen K; Genentech Inc, South San Francisco, CA, United States.
Joly J; Genentech Inc, South San Francisco, CA, United States.
Lubiniecki A; Janssen R&D LLC, Malvern, PA, United States.
Munro T; Amgen Inc, Thousand Oaks, CA, United States.
Russell R; Bristol Myers Squibb, Pennington, NJ, United States.
Wang T; Eli Lilly & Company, Indianapolis, IN 46285, United States.
Anderson K; Pfizer Inc, Andover, MA, United States.

Biologicals ; 44(2): 117-22, 2016 Mar.

Article em En | MEDLINE | ID: mdl-26852257

Assuntos

Biofarmácia/normas; Técnicas de Cultura de Células/normas; Linhagem Celular; Tecnologia Farmacêutica/normas; Animais; Humanos

Palavras-chave

Biopharmaceuticals; Chinese hamster ovary cells; Clonality; ICH guidelines; Product control strategy; Production cell line

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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Biofarmácia / Linhagem Celular / Tecnologia Farmacêutica / Técnicas de Cultura de Células Limite: Animals / Humans Idioma: En Revista: Biologicals Assunto da revista: ALERGIA E IMUNOLOGIA Ano de publicação: 2016 Tipo de documento: Article

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