2025.08.30
In the fast-evolving field of cell and gene therapy (CGT), cryopreservation isn’t just about cell survival—it’s about preserving functionality, potency, and therapeutic efficacy. Kryogene™ CFM-CGT has become the trusted choice for leading CGT developers, ensuring that CAR-T and stem cells maintain their critical attributes post-thaw.
· CAR-T Cells: Kryogene™ maintains >98% CAR expression post-thaw, with no loss in cytokine secretion (IFN-γ, IL-2) upon activation—critical for sustained anti-tumor activity.
· Stem Cells (MSCs/hPSCs): Ensures >95% viability while preserving key markers (CD73+/CD90+/CD105+) and differentiation potential (osteogenic, adipogenic, chondrogenic).
· FDA Master File (DMF 040563) & cGMP Manufacturing: Guarantees batch-to-batch consistency for seamless IND/BLA submissions.
· Animal Component-Free & Ultra-Low Endotoxin (<0.5 EU/mL): Minimizes immunogenicity risks, making it ideal for clinical use.
· Supports High Cell Densities: Validated for CAR-T (up to 2.5E+7 cells/mL) and MSCs (5E+6 cells/mL).
· Closed-System Compatibility: Works flawlessly with cryobags, vials, and automated fill-finish processes.
· Faster Recovery: CAR-T cells expand 1.5× faster post-thaw compared to conventional media.
· Stem Cell Potency: MSCs retain their doubling time (25–30 hrs) and differentiation efficiency (90% adipogenic/osteogenic capacity).
· Pre-Formulated DMSO: Eliminates manual errors in cryoprotectant preparation.
· Validated Freezing Protocols: Controlled-rate freezing (-1°C/min) and rapid thaw (37°C) maximize cell recovery.
Join the Leaders in Cell Therapy Innovation
Kryogene™ CFM-CGT is the gold standard for cryopreserving CAR-T and stem cells—ensuring potency, compliance, and scalability from R&D to commercialization.
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