Wednesday, 16 May 2007
3rd Floor Hall (Pfahler Hall)
174

Qualification of cation-exchange chromatography reduced-scale models and process characterization using a statistical Design of Experiment (DOE) approach

Nathan Skacel and Neil Maskeri. Global Biologics Supply Chain, Johnson & Johnson, Malvern, PA

Some process validation studies supporting biologics manufacturing, for practical reasons, must be performed at reduced scale in the laboratory. As a prerequisite, reduced-scale models must be qualified to demonstrate comparable performance to the manufacturing-scale process. GBSC Purification Technology has designed reduced-scale model qualification study for a cation-exchange chromatography process, and will show data that address the comparability of the reduced-scale model to manufacturing-scale data. In addition to model qualification, a factorial design of experiment (DOE) was employed with the reduced-scale model to characterize on the performance of the cation exchange chromatography step at or beyond the maximum operating ranges implemented at manufacturing scale. Data will be presented addressing product quality at or beyond manufacturing maximum operating range limits. This data can be used to establish critical process parameters (CPPs) that can be used in regulatory filings. The data will also support of future operating range non-conformances in manufacturing.

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