A multi-tiered analytical approach for the analysis and quantitation of high-molecular-weight aggregates in a recombinant therapeutic glycoprotein

AAPS Journal

Volumn 11, Issue 2, 2009, Pages 335-341

  Hughes, Heather ^a   Morgan, Charles ^b   Brunyak, Elizabeth ^a   Barranco, Kristen ^a   Cohen, Emily ^c   Edmunds, Tim ^a   Lee, Karen ^a  

^a GENZYME CORPORATION   (United States)

^b GENENTECH INC   (United States)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Aggregation; Analytical ultracentrifugation; Circular dichroism; Size exclusion chromatography

Indexed keywords

RECOMBINANT GLUCAN 1,4 ALPHA GLUCOSIDASE;

ACCURACY; ANALYTIC METHOD; ARTICLE; CIRCULAR DICHROISM; CONTROLLED STUDY; DRUG DETERMINATION; FREEZE THAWING; GEL PERMEATION CHROMATOGRAPHY; HIGH TEMPERATURE; HUMIDITY; MOLECULAR WEIGHT; PH; PROCESS OPTIMIZATION; PROTEIN AGGREGATION; PROTEIN ANALYSIS; PROTEIN DEGRADATION; PROTEIN FOLDING; PROTEIN MODIFICATION; PROTEIN PURIFICATION; PROTEIN SECONDARY STRUCTURE; PROTEIN TERTIARY STRUCTURE; QUANTITATIVE ANALYSIS; SEDIMENTATION VELOCITY ANALYTICAL ULTRACENTRIFUGATION;

ALPHA-GLUCOSIDASES; CHROMATOGRAPHY, GEL; CIRCULAR DICHROISM; DRUG STABILITY; DRUG STORAGE; GLYCOPROTEINS; HOT TEMPERATURE; HUMANS; HUMIDITY; HYDROGEN-ION CONCENTRATION; MOLECULAR WEIGHT; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS; SPECTROPHOTOMETRY, ULTRAVIOLET; ULTRACENTRIFUGATION;

EID: 68249159733     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-009-9108-1     Document Type: Article

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