Activation is the rate-limiting step in manufacturing CAR-T and genetically modified T cell therapies, heavily impacting vein-to-vein time, product quality, and cost.
This webinar presents mechanistic, clinical, and manufacturing data on cell-derived nanoparticle (CDNP)-based T cell activation (Synecta™) as an alternative to synthetic systems. Alongside data from Ori Biotech’s automated IRO® platform, the session explores how controlling activation kinetics and cell phenotype is critical for next-generation manufacturing success.
Key Learning Objectives
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Mechanisms & Kinetics: Examine data showing how Synecta™ simulates the immunological synapse to drive faster activation, reduce exhaustion markers, and improve memory subset distribution.
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Automated Manufacturing: Discover how the automated, closed-system IRO® platform utilizes dynamic mixing to boost lentiviral transduction efficiency and total CAR-T yield.
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Process Optimization: Review real-world data demonstrating a 3-day time-to-target dose, the elimination of de-beading and exogenous cytokines, improved consistency, and the successful expansion of difficult clinical samples.
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Clinical Translation: Assess in vivo potency and clinical durability outcomes (including NCT04684563) to evaluate how CDNP-based activation translates to patient success.
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Regulatory Strategy: Learn to leverage FDA-accepted DMFs and FDA AMT designations from BlueWhale and Ori to de-risk submissions for advanced manufacturing programs.
Featured Speakers
- Jessica Weaver, Bioengineer at Ori Biotech
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Pedro Moura, Senior Vice President, Head of Technology at BlueWhale Bio
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Brian Shy, Director of the Human Islet and Cellular Transplantation GMP Facility (HICTF) at UCSF
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Ke Li, Scientific Director of the Investigational Cellular Therapy Program at UCSF