Particle electrophoresis for quality assurance and process control

Area of Science:

• Life Sciences
• Analytical Chemistry
• Process Engineering

Background:

• Life science companies globally seek ISO and GMP compliance for manufacturing and product development.
• Process control is crucial for ensuring product quality and consistency in life science industries.
• Analytical Particle Electrophoresis (APE) is emerging as a valuable tool for process development and control.

Purpose of the Study:

• To explore the application of Analytical Particle Electrophoresis (APE) in life science process control.
• To demonstrate the utility of APE for assessing process consistency of both particles and the manufacturing environment.
• To highlight the role of polymer microspheres as control particles for instrument validation and assay medium probing.

Main Methods:

• Utilizing Analytical Particle Electrophoresis (APE) to measure surface charge properties of small particles (>100 nm).
• Employing direct measurements of charge properties of process particles and "reporter" particles for optimization.
• Leveraging advanced instrumentation and certified control particle preparations (e.g., NIST) for method validation.

Main Results:

• APE provides flexible electrophoretic strategies for assessing process consistency.
• Surface charge measurements offer insights into the behavior of colloidal particles in manufacturing processes.
• Polymer microspheres serve effectively as control particles for instrument validation and as probes for assay media.

Conclusions:

• APE is a powerful technique for enhancing process control and quality assurance in life science manufacturing.
• Understanding and measuring particle surface charge is key to optimizing life science products and processes.
• The integration of APE with validated control particles strengthens its applicability in regulated environments.