Use of process data to assess chromatographic performance in production-scale protein purification columns.

Biotechnol Prog

Manufacturing Science and Technology, Genentech, Inc., 1 DNA Way, MS 75B, South San Francisco, California 94080, USA.

Published: March 2004

AI Article Synopsis

  • Transition analysis was conducted on production-scale chromatography data to evaluate column performance, highlighting the effectiveness of the techniques used across over 300 different transitions.
  • The analysis successfully identified columns with known integrity breaches, demonstrating the sensitivity of the methods in detecting these issues.
  • PCA (principal components analysis) was utilized to observe changes in transition patterns, helping not only in breach detection but also in monitoring column efficiency during repeated uses.

Article 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.

Download full-text PDF

Source
http://dx.doi.org/10.1021/bp025639gDOI Listing

Publication Analysis

Top Keywords

integrity breaches
12
transition analysis
8
breaches transition
8
process data
4
data assess
4
assess chromatographic
4
chromatographic performance
4
performance production-scale
4
production-scale protein
4
protein purification
4

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!