BlueWhale Bio Receives FDA Advanced Manufacturing Technology (AMT) Designation for Synecta™ Cell-Derived Nanoparticle Platform

PHILADELPHIA, Nov. 18, 2025 /PRNewswire/ -- BlueWhale Bio, Inc., a company dedicated to transforming immune cell therapy manufacturing, today announced that its Synecta™ cell-derived nanoparticle (CDNP) platform for immune cell activation has been granted Advanced Manufacturing Technology (AMT) designation from the U.S. Food and Drug Administration (FDA).

Synecta leverages cell-derived nanoparticles (CDNPs) that mimic the natural activation of immune cells, producing higher-quality cells through a simplified, faster, and more scalable workflow.

The AMT designation is granted to technologies that improve manufacturing reliability and robustness and can benefit patients by enhancing product quality, reducing development time, or increasing or maintaining the supply of drugs that are life-supporting, life-sustaining, of critical importance to health care, or in short supply.

"This milestone affirms Synecta as a transformative tool for building consistent and efficient cell therapy processes. It highlights Synecta's role as an innovative approach for immune-cell activation in cell therapy manufacturing," said Peter Keller, CEO of BlueWhale Bio. "The FDA's recognition supports our partners as they advance their programs."

The designation enables early engagement with the FDA for programs using Synecta. It also signals confidence in the scalability of BlueWhale's CDNP manufacturing approach, an important consideration for future commercial use.

"We've seen strong activation performance and high-quality cells with Synecta," said Stephan Kadauke, MD, PhD, Children's Hospital of Philadelphia. "Having an FDA-recognized activation reagent provides valuable assurance as we plan next-generation manufacturing approaches."

With this designation, BlueWhale Bio gains regulatory recognition for its role in supporting the growing cell-therapy field. For further details about the FDA's Advanced Manufacturing Technologies Designation Program, visit FDA AMT Guidance.

About BlueWhale Bio

BlueWhale Bio accelerates the adoption of cell-based therapies by modernizing cell manufacturing. The company is developing a portfolio of critical materials that enable higher-performing cell therapies to reach more patients faster and at lower cost.

BlueWhale's innovations stem from discoveries in cell activation by Dr. Carl June and Dr. Jim Riley at the University of Pennsylvania. Its Synecta™ platform uses cell-derived nanoparticles (CDNPs) that mimic the natural activation of immune cells, producing superior cell quality through a simplified, faster, and more scalable workflow. The first product, Synecta T1, mimics natural T-cell stimulation by delivering membrane-bound signals, cytokines, and adhesion molecules that enhance T-cell receptor engagement during CAR-T manufacturing.

For more information, visit www.bluewhale.bio and follow us on LinkedIn.

SOURCE BlueWhale Bio, Inc.