Our

Technology

Quality Grades

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

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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.

Research
Enhanced
GMP (coming 2027)

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