Cell & Gene Therapies
Mass adoption of novel therapies requires safe, scalable, and regulatory ready systems
With over 14 years of experience in medical device, diagnostics, and life science product development, Tensentric’s interdisciplinary team of engineers, scientists, and designers has the capabilities for turn-key system development, from early concepts through volume manufacturing. By applying the rigor of medical design controls and quality management systems, Tensentric aims to maximize patient safety and ensure your therapies withstand the highest levels of regulatory scrutiny.
Cell and Gene Therapies Have Life-Saving Potential
In June 2012, Emily Whitehead was diagnosed with life-threatening acute lymphoblastic leukemia at only 6 years old. In an attempt to save her life, her parents enrolled her in a novel clinical trial for CAR-T immunotherapy, and Emily became the first child to receive the treatment. Her cancer went into complete remission immediately, and as of March 2023, she remains cancer-free 11 years later
Yet, as of April 2022, just 1.1% of total cell therapy trial candidates are past Phase II, and despite a 96% increase in preclinical, Phase I and II candidates over the last 3 years, forecasts of CGT FDA approvals remain relatively stagnant.
Additionally, only 14% of CGT candidates that enter Phase II progress to approval. When compared to the 43% rate from Phase II to approval for small molecule candidates, the CGT clinical bottleneck becomes obvious.
This means there’s still a major discrepancy between the number of patients receiving life-changing treatments, and the number of patients that need them.
At Tensentric, we’re dedicated to changing that by increasing analytical and developmental throughput of cell and gene therapies with custom, automated solutions from vein-to-vein.
Cell & Gene Therapy Scale-Up & Commercialization Capabilities
Scaling Solutions
As models scale, so do challenges. We can help you get ahead of trouble from IND to Phase III.
Research Tools
Plan for success from the start. Optimize research process variables for any delivery, editing or treatment system.
Bioprocessing Systems
Custom, regulatory-compliant systems to ensure your therapy is as safe and effective as possible.
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Interested in how we can help you?
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Our Clients Include…
A small number of partners we’ve worked with to bring products that solve key CGT commercialization challenges to market.