Built for process development on the path to GMP

Synecta™ T1 Enhanced Grade is designed for cell therapy programs moving beyond early research and into advanced process development, qualification, and clinical manufacturing readiness.

Enhanced Grade is manufactured in an ISO 9001:2015 facility, is protocol-driven with executed batch records. BlueWhale conducts QA/QC review and provides a Certificate of Analysis (CoA) and  clinical development documentation package.

This makes it well suited for engineering runs, process transfer, scale-up, qualification activities, comparability studies, and other development work intended to support transition to GMP-grade material.

Synecta T1 Enhanced Grade is well suited for:

• Engineering and pilot-scale runs
• Process transfer and scale-up
• Equipment and platform qualification
• Lot-to-lot variability assessment
• Analytical qualification
• Comparability and bridging studies
• Clinical process development
• Preparation for transition to GMP manufacturing