A new roadmap for biopharmaceutical drug product development: Integrating development, validation, and quality by design

Journal of Pharmaceutical Sciences

Volumn 100, Issue 8, 2011, Pages 3031-3043

  Martin Moe, Sheryl ^a,b   Lim, Fredric J ^a   Wong, Rita L ^a   Sreedhara, Alavattam ^a   Sundaram, Jagannathan ^a   Sane, Samir U ^a  

^a GENENTECH INC   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Biotechnology; Design space; Mixing; Process robustness; Process validation; Protein formulation; Quality by design (QbD); Regulatory science; Risk assessment; Unit operations

Indexed keywords

ACETIC ACID; POLYSORBATE 20; PROTEIN; TREHALOSE;

DRUG DESIGN; DRUG FORMULATION; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG STORAGE; FOOD AND DRUG ADMINISTRATION; NOTE; PARAMETER; PHARMACEUTICS; QUALITY BY DESIGN; QUALITY CONTROL; RISK ASSESSMENT; RISK MANAGEMENT; TECHNIQUE; VALIDATION PROCESS;

EID: 79958811141     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22545     Document Type: Note

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