Continuous capture scale down model: A comparison of a continuous and a discrete approach

Area of Science:

• Biopharmaceutical Manufacturing
• Chemical Engineering
• Process Development

Background:

• Continuous pharmaceutical manufacturing integrates fermentation and downstream processing.
• Continuous capture steps are critical for linking these processes.
• Scale-down models (SDMs) are essential for developing unit operations.

Purpose of the Study:

• To evaluate the suitability of discrete, non-continuous scale-down models (SDMs) for continuous protein A purification.
• To compare the performance of discrete SDMs against continuous SDMs in this context.

Main Methods:

• Development and application of a discrete scale-down model.
• Comparison with a continuous scale-down model for protein A chromatography.
• Focus on the continuous capture unit operation in pharmaceutical manufacturing.

Main Results:

• The discrete SDM approach proved suitable for the continuous protein A purification step.
• Discrete SDMs offer advantages such as simpler design, lower material consumption, and reduced operation time compared to continuous SDMs.

Conclusions:

• Discrete scale-down models are a viable and advantageous alternative to continuous SDMs for developing continuous protein A purification.
• This finding supports the use of discrete SDMs in optimizing continuous biopharmaceutical manufacturing processes.