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 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.
Larson
Tina M
TM
Manufacturing Science and Technology, Genentech, Inc., 1 DNA Way, MS 75B, South San Francisco, California 94080, USA. tinam@gene.com
Davis
Jeff
J
Lam
Harry
H
Cacia
Jerry
J
D000465:Algorithms; D016477:Artifacts; D002845:Chromatography / Q000295:instrumentation* / Q000379:methods*; D003198:Computer Simulation; D004868:Equipment Failure; D019544:Equipment Failure Analysis / Q000379:methods*; D015233:Models, Statistical; D025341:Principal Component Analysis; D011506:Proteins / Q000302:isolation & purification*; D014462:Ultrafiltration / Q000295:instrumentation / Q000379:methods
D011506:Proteins