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Synecta T1 is a cell-derived nanoparticle (CDNP) platform product developed by BlueWhale Bio for T cell activation and expansion in CAR-T cell manufacturing. The product mimics natural T cell stimulation through membrane-bound signals, cytokines, and adhesion molecules. Its composition includes activation signals and co-stimulatory ligands (OKT3 scFV, CD86, 4-1BBL) and cytokines (IL-15RA/IL-15, IL-7). Synecta T1 enables Day 0 transduction and Day 3 harvest manufacturing protocols, dramatically reducing the typical 9-14 day CAR-T manufacturing timeline to just 3 days. The technology is designed to address manufacturing bottlenecks by providing earlier cell division, higher cell yields, fewer process interventions, and reduced cell stress during manufacturing. The product can be used with any serum-free or serum-containing medium and is compatible with various vessels and bioreactors. The recommended dose is 30 μL per 1 million cells. Synecta T1 is stored at -80°C long term and can be refrozen once after thawing. The Drug Master File for Synecta T1 CDNPs has been accepted by the FDA. The technology is based on discoveries in cell activation led by Dr. Carl June and Dr. Jim Riley at the University of Pennsylvania.
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