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For Non-Excipient Use: By purchasing this product, you agree that you will not use it as an excipient. For Excipient Use: Purchasing this product for excipient use requires a signed Excipient Use Agreement (EUA) for regulatory support.
Protein-free, animal component-free, chemically defined cryopreservation medium
Designed to maintain viability and maximize efficiency for preserving cells in today’s advanced applications.
Facilitates cell preservation for short-term at -80°C and long-term storage in liquid nitrogen to -196°C
Achieves high post-thaw viability and growth. Viability of thaw cell typically within 10% of freezing cell viability. (Viability assessed by Trypan Blue assay)
Maintains cell surface marker expression of mesenchymal stromal/stem cells (MSCs), HSCs, and PBMCs (T cells) post-thaw
Supports cell density for MSC and HSC from 0.5 X 106 cells/mL to 1 X 106 cells/mL and PBMCs (T cells) minimum 5 X 106 cells/mL
Excipient (91139EX)* and non-excipient (91139)** products available as complete, ready-to-use media
Contains DMSO in the formulation
Accelerate life-changing therapies to market: Now available as an excipient and non-excipient medium
The cutting-edge formulations of PRIME-XV FreezIS Cryopreservation Media Portfolio are optimized to protect and preserve cells without compromising functionality no matter how manufacturing needs change.
*Excipient products are for research or further manufacturing use only. Not for injection as a standalone product or diagnostic procedures. Product can be used as excipient, which means that the cells and media combined are treated as one product that is to be approved by the FDA. Testing for individual applications is the responsibility of the customer.
**Non-excipient products are for research or further manufacturing use only. Not for injection or diagnostic procedures. Testing for individual applications is the responsibility of the customer.
Maintains High Post-Thaw Viability of MSCs
Figure 1. PRIME-XV FreezIS supports high post-thaw viability of MSCs. Human adipose-derived mesenchymal stromal/stem cells (MSCs) had high plating efficiency (A) and viability (B) 24 hours post-thaw after cryopreservation in PRIME-XV FreezIS compared to a commercially-available cryopreservation solution. Images were taken at 10X magnification.
Maintains PBMC Viability and Cell Recovery
Figure 2. PRIME-XV FreezIS supports cryopreservation and recovery of PBMCs. (A) Fresh human peripheral blood mononuclear cells thawed and cultured for 13 days yielded 100-fold expansion. (B) PBMCs thawed from PRIME-XV FreezIS showed a slightly higher viability at thaw and maintained a viability above 85% over the 13 days in culture. (C) Cell diameter increases post-thaw as the cells recover from the cryopreservation, returning to baseline 24 hours later. Cell diameter is highest at the peak of the exponential growth phase around Day 7 and returns to baseline again at the end of expansion.
Manufactured to facilitate transfer from research to clinic with robust raw material controls and supply chain management support
FDA, Federal, and State registered – GMP 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
Custom sizes and packaging available upon request.
Contact us for international pricing and custom formulations.
Specifications
Storage
This product is shipped at 2-8°C with cold packs. Upon receipt, store immediately at 2-8°C and protect from light.
Shelf Life
Handle using aseptic techniques to avoid contamination. Unopened liquid medium is stable for 24 months from date of manufacture, as indicated on the label.
