Use of Process Data To Assess Chromatographic Performance in Production-Scale Protein Purification Columns

Transition analysis was performed on production‐scale chromatography data in order to monitor column performance. Analysis of over 300 transitions from several different chromatography operations demonstrated the utility of the techniques presented. Several of the transitions analyzed occurred on co...

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Bibliographic Details
Published in:Biotechnology progress 2003, Vol.19 (2), p.485-492
Main Authors: Larson, Tina M., Davis, Jeff, Lam, Harry, Cacia, Jerry
Format: Article
Language:English
Subjects:
Algorithms
Biological and medical sciences
Chromatography - instrumentation
Chromatography - methods
Computer Simulation
Equipment Failure
Equipment Failure Analysis - methods
Fundamental and applied biological sciences. Psychology
Models, Statistical
Principal Component Analysis
Proteins - isolation & purification
Ultrafiltration - instrumentation
Ultrafiltration - methods
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Summary:Transition analysis was performed on production‐scale chromatography data in order to monitor column performance. Analysis of over 300 transitions from several different chromatography operations demonstrated the utility of the techniques presented. Several of the transitions analyzed occurred on columns with known integrity breaches. The techniques proved sensitive for detection of these breaches. Seven transition calculations are presented, which were combined to produce a single overall integrity value for each column. In addition, principal components analysis (PCA) was used to detect shifts in the transition pattern, including those attributed to integrity breaches. Besides detection of integrity breaches, transition analysis proved useful in monitoring column efficiency over multiple column uses.
ISSN:8756-7938
1520-6033
DOI:10.1021/bp025639g