2025.08.09
In the high-stakes world of cell and gene therapy, cryopreservation quality directly impacts therapeutic outcomes. Here’s why industry leaders trust Kryogene™ CFM-CGT:
· CAR-T Cells: Maintains >98% CAR expression post-thaw (vs.<93% in competitors) and near-identical cytokine release (IFN-γ, IL-2) after activation.
· Stem Cells (MSCs/hPSCs): Preserves >95% viability, 99% stemness markers (CD73+/CD90+/CD105+), and differentiation potential (osteogenic/adipogenic/chondrogenic).
· FDA Master File (DMF 040563) & cGMP Manufacturing: Ensures batch consistency for IND/BLA submissions.
· Animal Component-Free & Ultra-Low Endotoxin (<0.5 EU/mL): Reduces immunogenicity risks in clinical applications.
· High-Density Support: Validated at up to 2.5E+7 cells/mL for CAR-T and 5E+6 cells/mL for MSCs.
· Closed-System Compatibility: Works seamlessly with cryobags/vials and automated fill-finish systems.
· CAR-T Expansion: 1.5× higher cell density recovery after 24h culture vs. conventional media.
· Stem Cell Potency: Post-thaw MSC doubling time matches fresh cells (25–30 hrs), with 90% adipogenic/osteogenic capacity retained.
· Pre-Formulated DMSO: Eliminates manual prep errors.
· Optimized Protocols: Controlled-rate freezing (-1°C/min) and rapid thaw (37°C) ensure maximum recovery.
Join Innovators Transforming Cell Therapy
From R&D to commercial-scale production, Kryogene™ CFM-CGT delivers the consistency, compliance, and cell potency demanded by leading CGT developers.
Request validation data: info@milecell-bio.com | Explore Kryogene™: milecell-bio.com
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