Application of the Quality by Design approach to the drug substance manufacturing process of an Fc fusion protein: Towards a global multi-step design space

Journal of Pharmaceutical Sciences

Volumn 101, Issue 10, 2012, Pages 3604-3618

  Eon Duval, Alex ^a   Valax, Pascal ^a   Solacroup, Thomas ^a   Broly, Hervé ^a   Gleixner, Ralf ^a   Le Strat, Claire ^a   Sutter, James ^a  

^a MERCK SERONO S A   (Switzerland)

Author keywords

Biotechnology; Design space; Mathematical models; Multivariate analysis; Proteins; Quality by design; Regulatory science; Validation

Indexed keywords

FC FUSION PROTEIN; HYBRID PROTEIN; INSULIN; UNCLASSIFIED DRUG;

ARTICLE; DEAMINATION; DNA CONFORMATION; DRUG DESIGN; DRUG MANUFACTURE; DRUG QUALITY; GLYCATION; GLYCOSYLATION; GOOD MANUFACTURING PRACTICE; HUMAN; MULTIVARIATE ANALYSIS; NONHUMAN; OXIDATION; PRODUCT DEVELOPMENT; QUALITY BY DESIGN APPROACH; QUALITY CONTROL; QUALITY CONTROL PROCEDURES; RISK ASSESSMENT; RISK MANAGEMENT; STATISTICAL MODEL; VALIDATION STUDY;

EID: 84865369903     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.23273     Document Type: Note

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