Our mission is to revolutionize cell therapy manufacturing through innovative bioreactor solutions, empowering the advancement of personalized treatments for improved patient outcomes.

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Cancer remains a leading cause of death globally and presents a significant burden on healthcare systems and economies. Popular treatment modalities, such as radiation and chemotherapy, harm healthy tissue or are limited in their efficacy against metastatic or blood cancers. A growing number of FDA-approved CAR-T therapies show great promise as an effective cancer treatment but face challenges in manufacturing, with cell requirements reaching up to 250 million CAR-T cells per infusion. Despite ongoing efforts to develop bioreactors for efficient cell expansion, current manufacturing solutions are unable to meet the demand for CAR-T therapies, underscoring a gap in fulfilling this critical requirement and emphasizing the need for innovative solutions to enhance CAR-T therapy adoption.

 

To optimize the manufacturing process, we have developed a centrifugal fluidized expansion (CentriFLEX) perfusion bioreactor that balances centrifugal forces with a continuous feed of fresh media. Unlike current expansion systems, the CentriFLEX resolves a key manufacturing bottleneck in continuous cell culture—prevention of cell product loss while simultaneously feeding fresh media and removing inhibitory cellular waste. The CentriFLEX also eliminates the need for membrane filters used in current perfusion bioreactors, which are prone to fouling, an expensive and prominent issue. Proof-of-concept studies expanding murine and bovine cell lines demonstrate the CentriFLEX:

 

1. Produces competitive cell densities above 100 million cells/mL.

2. Maintains growth rates at 95% of the maximum value.

3. Reduces the manufacturing time by 30% compared to competing technologies

 

Additionally, the CentriFLEX takes 0.5 sqm of footprint on a standard lab bench and is self-contained, with its housing acting as a mini-biosafety cabinet with HEPA filters and UV-C sterilization—eliminating the need for multimillion-dollar GMP cleanrooms. The CentriFLEX holds immense promise to transform CAR-T therapy production, making it accessible, scalable, and cost-effective, ultimately benefitting patients and healthcare providers worldwide.