PRIME-XV FreezIS Excipient
Supplier: FUJIFILM IRVINE SCIENTIFIC INC.
Protein-free, animal component-free, excipient chemically defined cryopreservation solution.
Protein-free, animal component-free, chemically defined cryopreservation solution
Enables cell preservation for short-term at –80 °C and long-term storage in liquid nitrogen to –196 °C
High post-thaw viability and growth
Maintains cell surface marker expression of mesenchymal stem cells (MSCs) and T cells post-thaw
Complete, ready-to-use medium
Contains DMSO in the formulation
Designed and manufactured to facilitate transfer from research to clinic
Supported by robust raw material controls and supply chain management
Certifications:
FDA, Federal, and State registered - cGMP-compliant manufacture
EN ISO 13485:2016 certified MDSAP certified
Extensive QC testing including functionality, sterility (USP <71>), endotoxin (USP <85>), and mycoplasma (USP <63>)
Drug Master Files (DMFs) filed with the FDA - available upon request
Excipient Use Agreement (EUA) will need to be signed for regulatory support
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