This white paper examines critical process parameters (CPPs) in biopharma downstream processing (DSP), essential for ensuring product quality, safety, and efficacy. It highlights how Process Analytical Technology (PAT) enables real-time monitoring of CPPs such as pH, conductivity, protein concentration, temperature, pressure, turbidity, and redox potential across key DSP steps—buffer preparation, chromatography, filtration, and viral inactivation. Both reusable and Single-Use skid technologies are discussed, emphasizing their role in continuous vs. batch operations. By linking CPPs to critical quality attributes (CQAs), the paper underscores the importance of sensor-based monitoring to achieve robust, efficient, and compliant manufacturing.

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