Wednesday, 16 May 2007 - 2:35 PM
106 (Pfahler Hall)
117

Mixing Technology Evaluation and Optimization

Farid Ighemat, Centocor P.D. Pilot Plant / Spring House, Spring House, PA

Efficient mixing of Protein A chromatography eluate is critical for viral inactivation, neutralization, and pH adjustment during protein recovery operations. Therefore, a comprehensive evaluation was performed on current disposable mixing systems. Three types of disposable mixing technologies were evaluated for Protein A eluate recovery operations. A bottom drain recirculation BioProcess container (BPC) with tubing and peristaltic pump, a magnetic stir bar/BPC system, and a levitated magnet/BPC system were compared at a 50-liter scale. Each system was evaluated for performance, functionality, setup/turn-around, complexity, failure modes, validation requirements, footprint, materials of construction, customization options, and cost. The system selected for use at the small scale was further evaluated to assure compatibility with large scale manufacturing operations.

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