2025.09.17
In the race to bring cell therapies to patients, every step counts—especially cryopreservation. Kryogene™ CellFreezing Media-CGT isn’t just another freezing medium—it’s your regulatory-ready partner from preclinical to IND submission and beyond.
· FDA Master File (DMF #040563): Pre-reviewed formulation eliminates regulatory uncertainty
· Full cGMP Manufacturing: ISO 13485-certified facility with batch records for seamless tech transfer
· Endotoxin-Free (<0.5 EU/mL): Meets USP<85>standards for injectable therapies
✔ Lot-to-Lot Consistency: ≤5% variability in post-thaw viability (N=20 batches)
✔ Direct Clinical Translation: Identical formulation from R&D to commercial GMP batches
✔ Documentation Package: Includes CoA, CoC, TSE/BSE statements, and full traceability
· CAR-T Cells: 98.2±1.3% viability with stable CAR expression
· MSCs: Maintains trilineage differentiation potential post-thaw (Oil Red O/Alizarin Red staining)
· iPSCs: >90% pluripotency marker retention (Oct4+/Nanog+)
Our pre-formulated, ready-to-use solution eliminates:
➤ Manual DMSO mixing errors
➤ In-house sterility testing burdens
➤ Stability validation studies
From Lab to Clinic Without Cold Chain Gaps
With Kryogene™ CFM-CGT, your cells transition smoothly from research-grade to clinical-grade freezing—without reformulation or requalification.
Request validation data: Info@milecell-bio.com
Learn more: milecell-bio.com
#CellTherapy #GMP #FDARegulatory #INDEnabling #Cryopreservation #Biomanufacturing #Kryogene #CellAndGene #ClinicalTranslation #CDMO
