Feasibility of scaling from pilot to process scale

Area of Science:

• Chemical Engineering
• Separation Science
• Chromatography

Background:

• The pharmaceutical industry requires scalable, economical, and reliable technologies for drug purification.
• Large scale counter-current chromatography (CCC) is an emerging technology with potential for process scale-up.
• Key scale-up variables for CCC, such as rotor radius and tubing bore, require further investigation.

Purpose of the Study:

• To investigate the impact of rotor radius on CCC performance.
• To examine the effect of tubing bore on CCC performance.
• To identify optimal parameters for scalable CCC in pharmaceutical manufacturing.

Main Methods:

• Studied the effect of rotor radius (50 mm, 110 mm, 300 mm) using identical coil parameters.
• Investigated tubing bore effects (up to 17.5 mm) on a 300 mm radius centrifuge.
• Analyzed retention and resolution across varied operational parameters.

Main Results:

• Rotor radius showed minimal impact on retention and resolution at constant tubing bore.
• Increasing tubing bore maintained good retention with only a slight decrease in resolution.
• High throughputs (>25 kg/day) are achievable with optimized high-bore tubing and flow rates.

Conclusions:

• Rotor radius is not a critical factor for scale-up in CCC under constant conditions.
• Tubing bore is a crucial parameter for optimizing CCC throughput and efficiency.
• CCC technology, particularly with optimized tubing bore, is viable for large-scale pharmaceutical production.