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

Biologicals

Volumn 44, Issue 2, 2016, Pages 117-122

  Frye, Christopher ^a   Deshpande, Rohini ^b   Estes, Scott ^c   Francissen, Kathy ^d   Joly, John ^d   Lubiniecki, Anthony ^e   Munro, Trent ^b   Russell, Reb ^f   Wang, Tongtong ^a   Anderson, Karin ^g  

^a ELI LILLY AND COMPANY   (United States)

^b AMGEN INC   (United States)

^c BIOGEN   (United States)

^d GENENTECH INC   (United States)

^e Janssen RandD LLC   (United States)

^f BRISTOL MYERS SQUIBB   (United States)

^g PFIZER INC   (United States)

Author keywords

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

Indexed keywords

RECOMBINANT DNA;

BIOMEDICINE; BIOPHARMACEUTICAL PRODUCING CELL LINE; BIOTECHNOLOGICAL PRODUCTION; COMMERCIAL PHENOMENA; CONTROL STRATEGY; DRUG MANUFACTURE; MANUFACTURING INDUSTRY; MOLECULAR CLONING; NOTE; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PRODUCT DEVELOPMENT; PRODUCT SAFETY; RISK ASSESSMENT; RISK MANAGEMENT; VALIDATION PROCESS; ANIMAL; CELL CULTURE TECHNIQUE; CELL LINE; HUMAN; PHARMACEUTICS; STANDARDS;

ANIMALS; BIOPHARMACEUTICS; CELL CULTURE TECHNIQUES; CELL LINE; HUMANS; TECHNOLOGY, PHARMACEUTICAL;

EID: 84960384547     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2016.01.001     Document Type: Note

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