Articles by Rick E. Cooley - BioPharm International

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Articles by Rick E. Cooley

ON-LINE PROCESS CONTROL: Automating the Control of Process-Scale Purification Columns Using On-Line Liquid Chromatography

Using on-line HPLC to monitor the eluent from process-scale columns allows the process decision—when to start and stop collection—to be based on a critical quality attribute rather than on a surrogate measurement.
Feb 2, 2007

This article discusses how on-line high-performance liquid chromatography (HPLC) can measure product purity in the column eluent stream in near–real time. These data can then enable the automation and control of a purification column operation, thus reducing product variability, shortening process cycle time, and increasing yield. An example application demonstrates how on-line HPLC is used as a process analytical technology to ensure the process can accommodate variability in the separation while ensuring the product meets its critical quality attributes.

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