Challenging the Microbial Sanitization of a Liquid Chromatography System

In developing biologics or biotherapeutics, a great deal of effort is used to ensure that none of the contaminating or hazardous residual components from the organisms responsible for protein expression remain after purifi cation. As a result, additional sanitization steps may be required for the instrumentation utilized in these purifi cation processes.

In this study, microbial challenge was performed on the NGC Chromatography System using a bacterial strain and two yeast strains commonly used in purifi cation environments. These organisms were used to contaminate the entire NGC System for 24 hours, followed by a sanitization process. Sanitization of the system was completed using a cleaning-in-place (CIP) method with 1 M NaOH resulting in a greater than 6 log reduction in microorganisms using colony forming units (CFU) as the test indicator. Extended incubation with 1 M NaOH also reduced endotoxins to acceptable levels. We conclude that the NGC System is capable of being sanitized making it an ideal platform for the small-scale production of biotherapeutics.

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