Standardization, evaluation and early-phase method validation of an analytical scheme for batch-consistency N-glycosylation analysis of recombinant produced glycoproteins

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 68, Issue 3, 2008, Pages 818-827

  Zietze, Stefan ^a   Müller, Rainer H ^b   Brecht, René ^a  

^a PROBIOGEN AG   (Germany)

^b FREIE UNIVERSITÄT BERLIN   (Germany)

Author keywords

Biotechnology; Glycosylation; Pharmaceutical analysis; Quality control; Validation

Indexed keywords

GLYCOPROTEIN; OLIGOSACCHARIDE; RECOMBINANT PROTEIN;

ARTICLE; ENZYME DEGRADATION; GLYCOSYLATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; METHODOLOGY; PROTEIN MODIFICATION; QUALITY CONTROL; STANDARDIZATION; VALIDATION PROCESS;

CHROMATOGRAPHY, HIGH PRESSURE LIQUID; GLYCOPROTEINS; GLYCOSYLATION; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS;

EID: 39849109524     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2007.08.015     Document Type: Article

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