Model-based risk analysis of coupled process steps

Biotechnology and Bioengineering

Volumn 110, Issue 9, 2013, Pages 2462-2470

  Westerberg, Karin ^a   Broberg Hansen, Ernst ^b   Sejergaard, Lars ^b   Nilsson, Bernt ^a  

^a LUND UNIVERSITY   (Sweden)

^b NOVO NORDISK A S   (Denmark)

Author keywords

Critical process parameters; Modeling; Process characterization; Quality by design; Size exclusion chromatography

Indexed keywords

CRITICAL PROCESS PARAMETERS; EXPERIMENTAL VERIFICATION; MANUFACTURING PROCESS; MODEL-BASED RISK ANALYSIS; PROCESS CHARACTERIZATION; QUALITATIVE RISK ASSESSMENT; QUALITY BY DESIGNS; THERAPEUTIC PROTEIN;

MODELS; PRODUCT DESIGN; QUALITY CONTROL; RISK ASSESSMENT;

SIZE EXCLUSION CHROMATOGRAPHY;

POLYMER;

ARTICLE; CONDUCTANCE; CONJUGATE; ENZYME KINETICS; EXPERIMENTAL STUDY; GEL PERMEATION CHROMATOGRAPHY; PH; PROCESS DEVELOPMENT; PROCESS MODEL; QUALITATIVE ANALYSIS; REACTION ANALYSIS; REACTION TIME; RISK ASSESSMENT; SENSITIVITY ANALYSIS; SIMULATION; TEMPERATURE; TEMPERATURE DEPENDENCE;

CRITICAL PROCESS PARAMETERS; MODELING; PROCESS CHARACTERIZATION; QUALITY BY DESIGN; SIZE-EXCLUSION CHROMATOGRAPHY;

BIOTECHNOLOGY; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, GEL; MODELS, THEORETICAL; POLYMERS; PROTEINS; RESEARCH DESIGN; RISK;

EID: 84880822794     PISSN: 00063592     EISSN: 10970290     Source Type: Journal    
DOI: 10.1002/bit.24909     Document Type: Article

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