The right Synecta™ T1 for every stage of development
From early discovery through clinical process development and commercial manufacturing, your activation reagent should be able to advance with your process.
BlueWhale Bio offers phase-appropriate quality grades designed to support a streamlined transition from research and process development to GMP manufacturing. Each grade provides defined manufacturing controls, appropriate quality oversight, and documentation appropriate to its intended use – while maintaining the same Synecta T1 activation technology across development stages.
Research Grade is available for discovery, proof-of-concept, assay development, and early process development.
Enhanced Grade adds manufacturing controls, quality oversight, and documentation designed to support later-stage process development, engineering runs, qualification activities, comparability, and transition planning toward GMP manufacturing.
GMP Grade, planned for early 2027, will support clinical and commercial manufacturing applications.
Quality Features:
RESEARCH
ENHANCED
GMP
Certificate of Analysis
QC release
QC oversight
Protocol-driven manufacturing
Executed batch records
Enhanced traceability & documentation
GMP QA release
DMF support
Synecta™ T1 Enhanced and GMP grades are manufactured at Avantor’s Bridgewater Innovation Center, an ISO 9001:2015-certified facility supporting scale-up and phase-appropriate manufacturing.