Biomanufacturing process analytical technology (PAT) application for downstream processing: Using dissolved oxygen as an indicator of product quality for a protein refolding reaction

Biotechnology and Bioengineering

Volumn 104, Issue 2, 2009, Pages 340-351

  Pizarro, Shelly A ^a   Dinges, Rachel ^a,b   Adams, Rachel ^a   Sanchez, Ailen ^a   Winter, Charles ^a  

^a GENENTECH INC   (United States)

^b PFIZER INC   (United States)

Author keywords

Dissolved oxygen sensor; Downstream processing; PAT; Process analytical technology; Protein refolding

Indexed keywords

BIOMANUFACTURING; CONSTANT MASS; CONTINUOUS MONITORING SYSTEMS; DOWNSTREAM PROCESSING; IN-LINE; KNOWLEDGE-BASED APPROACH; MANUFACTURING OPERATIONS; OXIDATIVE DEGRADATION; PAT; PROCESS ANALYTICAL TECHNOLOGY; PROCESS PERFORMANCE; PROCESS VARIABILITY; PRODUCT QUALITY; PROTEIN REFOLDING; RECOMBINANT HUMAN VASCULAR ENDOTHELIAL GROWTH FACTOR; REDUCING ENVIRONMENT; REFOLDING; REFOLDING PROCESS; REFOLDING REACTION; REVERSE PHASE HPLC; RP-HPLC; SCALE-UP; STATISTICAL TOOLS;

DISSOLUTION; DISSOLVED OXYGEN SENSORS; KNOWLEDGE BASED SYSTEMS; QUALITY CONTROL; REGULATORY COMPLIANCE; SENSORS; STATISTICAL MECHANICS; TECHNOLOGY;

DISSOLVED OXYGEN;

DISSOLVED OXYGEN; NITROGEN; PROTEIN; RECOMBINANT VASCULOTROPIN;

AERATION; AIR; ARTICLE; BIOREACTOR; DOWNSTREAM PROCESSING; DRUG MANUFACTURE; ESCHERICHIA COLI; FERMENTATION; FOOD AND DRUG ADMINISTRATION; HUMAN; MONITORING; NONHUMAN; OXIDATION; PROCESS ANALYTICAL TECHNOLOGY; PROCESS TECHNOLOGY; PROTEIN FOLDING; QUALITY CONTROL; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SCALE UP; SENSOR;

BIOREACTORS; BIOTECHNOLOGY; HUMANS; OXYGEN; PROTEIN FOLDING; QUALITY CONTROL; RECOMBINANT PROTEINS; VASCULAR ENDOTHELIAL GROWTH FACTOR A;

EID: 70349330797     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.22382     Document Type: Article

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