Stealth Biomanufacturing Startup Information

We believe the next generation of therapies deserves the next generation of manufacturing tools. With over 4,400 programs in the clinical pipeline globally, breakthrough cell and gene therapies are advancing faster than the manufacturing tools needed to produce them at scale. Fouling remains a persistent challenge in perfusion manufacturing, disrupting production, limiting cell density, and extending manufacturing timelines. Our solution: the CentriFLEX, a next-generation bioreactor that eliminates fouling by design. The CentriFLEX balances centrifugal and opposing fluid forces to retain cells in conical chambers mounted on a rotor disc. No membranes, no fouling. Its multi-chamber design supports scalability, and early testing has shown the potential to reduce manufacturing time by over 30%. Informed by more than 180 customer discovery interviews, the CentriFLEX addresses the need for a perfusion bioreactor that avoids fouling and adapts to evolving production requirements as a therapy moves from preclinical development to commercial manufacturing. The technology's development has been supported by nearly $700,000 in federal and state grant funding, helping advance it from academic research to a working prototype, alongside published expansion studies with human cell lines. Songenova is now advancing toward beta testing with strategic partners and integrating automation and process controls informed by customer feedback. Our mission is to advance manufacturing technology so promising therapies can reach the patients who need them.