Rapid implementation of the Accellix Automated Platform in GMP manufacturing

Cell and gene therapies have delivered transformative treatment opportunities for patients suffering from circulating tumors and rare diseases. Rapid in-process testing improves manufacturing efficiency and maximizes cell availability for dose preparation. Flow cytometry tests to support manufacturing requires strict adherence to ICH and pharmacopeial guidelines and a robust analytical platform. We discuss applications of automated flow cytometry analyses in cell therapy manufacturing and approaches toward analytical method validation.

• Areas where in-process flow cytometry testing is considered critical.
• Impact of automation in flow cytometry sample preparation and analysis.
• Considerations for building an automated phenotyping test.
• Newer areas of interest and development for automated flow cytometry.