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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.
Ensure Potency That Therapies Require Without the Toxicity Risk
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.DMSO-free, protein-free, animal component-free, chemically defined cryopreservation medium
Designed to maintain viability and maximize efficiency for preserving cells in today’s advanced applications.
Eliminates the risk of DMSO toxicity and maintains potency of human mesenchymal stromal/stem cells (MSCs), PBMCs (T cells), and hematopoietic stem cells (HSCs) throughout cryopreservation
Achieves high post-thaw viability and growth: Viability of thaw cell typically within 10% of freezing cell viability. (Viability assessed by Trypan Blue assay)
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
Maintains cell surface marker expression of MSCs and PBMCs (T cells) post-thaw
Preserves the physical integrity and functionality of cells post-thaw after storage for short-term at -80°C* and long-term storage in liquid nitrogen to -196°C
Can directly replace DMSO- and/or serum-containing media with comparable post-thaw cell viability
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.
For tissue banks we recommend following the guidelines provided by each individual tissue bank and local regulations. Excipient (91140EX)** and non-excipient (91140)† products are available as complete, ready-to-use media.
*Human MSC and PBMC (T Cell) data available for short-term storage. Human HSC data is not available.
**Excipient products are for research or further manufacturing use only. Not for injection as a stand-alone 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.
Supports Comparable MSC Viable Cell Density and Percent Viability with DMSO-free and DMSO-containing Media
Figure 1. PRIME-XV FreezIS DMSO-Free retains comparable MSC viable cell density and percent viability after cryopreservationcompared to DMSO-containing solution.Human adipose-derived MSCs were frozen in PRIME-XV FreezIS DMSO-Free and in PRIME-XV FreezIS. The cells were stored in liquid nitrogen for 2 days before they were thawed and cultured through 2 passagesuntil80% confluent. The viable cell density (A) and percent viability (B) were assessed with trypan blue staining in a Vi-CELL Cell ViabilityAnalyzer at thaw and 2 passages post-thaw. Viable cell density was calculated using the cell count multiplied by the volume.
PRIME-XV FreezIS DMSO-Free Successfully Protects Human T Cells Potency and Viability
Figure 2. Cells frozen in PRIME-XV FreezIS DMSO-Free show robust expansion if plated directly into culture medium after thaw, without washing out the cryopreservation medium. Cells cultured in 24-well R-series G-Rex plates (A) and 6-well M-series G-Rex plates (C) recovered well from cryopreservation when plated directly into cell culture media post-thaw. Cells thawed from PRIME-XV FreezIS DMSO-Free media best maintained pre-freeze viability in the first 24 hours post-thaw (B). Data is representative of 3 donors.
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.
