On-line Measurements and Control of Viable Cell Density in Cell Culture Manufacturing Processes using Radio-frequency...

Area of Science:

• Biotechnology
• Process Analytical Technology (PAT)
• Cell Culture Manufacturing

Background:

• Radio-frequency (RF) impedance is a non-invasive technique for assessing cell characteristics.
• Accurate monitoring of cell bio-volume is critical for optimizing biomanufacturing processes.
• Current methods for cell counting can be time-consuming and may not be suitable for all culture types.

Purpose of the Study:

• To review RF impedance as a method for monitoring and controlling cell culture manufacturing.
• To highlight the applications of RF impedance in current Good Manufacturing Practice (cGMP) production.
• To assess the suitability of RF impedance for various cell types and immobilization methods.

Main Methods:

• Literature review of publications on RF impedance in cell culture.
• Analysis of RF impedance applications in perfusion cultures and bioreactor control.
• Evaluation of RF impedance as a monitoring tool for product conformance and immobilized cell concentrations.

Main Results:

• RF impedance is an accurate and reliable method for measuring live cell bio-volume both on-line and off-line.
• The technology is suitable for animal cells in suspension, attached to micro-carriers, or immobilized in fixed beds.
• RF impedance is utilized in cGMP production for process control, product conformance monitoring, and assessing immobilized cell concentrations.

Conclusions:

• RF impedance offers significant advantages for real-time monitoring and control in cell culture manufacturing.
• It enables optimization of bioreactor conditions for enhanced production of valuable biomolecules.
• RF impedance provides a robust solution for cell monitoring where traditional methods are inadequate.