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Use of Process Data To Assess Chromatographic Performance in Production‐Scale Protein Purification Columns
Author(s) -
Larson Tina M.,
Davis Jeff,
Lam Harry,
Cacia Jerry
Publication year - 2003
Publication title -
biotechnology progress
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.572
H-Index - 129
eISSN - 1520-6033
pISSN - 8756-7938
DOI - 10.1021/bp025639g
Subject(s) - column (typography) , principal component analysis , chromatography , scale (ratio) , production (economics) , process (computing) , chemistry , computer science , artificial intelligence , physics , telecommunications , frame (networking) , quantum mechanics , operating system , economics , macroeconomics
Abstract 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.