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Maximize human mesenchymal stromal/stem cell (MSC) expansion and differentiation within a fully closed system
The PRIME-XV MSC XSFM Dual Component Kits are xeno-free and serum-free media that enable a single-use, closed system format for MSC expansion in Quantum or other compatible hollow fiber bioreactors. The medium is formulated to deliver expansion and viability of MSCs over several passages in culture, while maintaining multipotency and functional characteristics.
The PRIME-XV MSC XSFM Dual Component Kits offer a closed-system solution that includes basal media and supplement for use with use with Quantum* or other compatible hollow fiber bioreactors.
Enables up to an 8-fold increase in MSC expansion (donor-dependent)
Yields 200 x 106 cells in 7 days of expansion with 90% and above viability
Supports expansion of MSCs; data derived from human adipose tissue (as shown in Figure 1)
Maintains lot-to-lot consistency with xeno- and serum-free media
Simplifies and expedites process of MSC expansion for large scale solutions
Minimizes risk of contamination and cell stress, and increases efficiency
Does not contain antibiotics
Available with or without phenol red
Designed and manufactured following relevant GMPs, such as raw material controls and supply chain management, to facilitate transfer from research to clinic:
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>)
The PRIME-XV MSC XSFM Dual Component Kits are for research or further manufacturing use only.
*Quantum Bioreactor protocol available in IFU (Product Insert)
Figure 1. PRIME-XV MSC XSFM Dual Component Kit with Phenol Red performs similarly or better than the thawed PRIME-XV MSC Expansion XSFM (Complete Medium). Results from three different donors demonstrate some donor-to-donor variability in fold expansion of ADMSCs. Viability is consistently maintained at or above 90% over the course of the 7-day expansion. The discrepancy in the average performance between the dual bag and complete conditions may be explained by differences in initial storage temperature. Due to the large volume (5 L) of frozen media in the complete PRIME-XV MSC Expansion XSFM, it had to be thawed in the refrigerator for over 48 hours to completely thaw, whereas the temperature-sensitive components of the dual component bag were thawed less than an hour before the initiation of the expansion, and thus had less time to degrade.
Figure 2. ADMSCs maintain their stem cell phenotype at Day 7 post-expansion in PRIME-XV MSC XSFM Dual Component Kit with Phenol Red. The expression of negative markers CD34 and CD45 remained well below 2% over the course of the culture. The expression of the positive markers CD73, CD90, and CD105 ranged from 94-100%, indicating the maintenance of MSC differentiation potential over the course of the culture, similar to the complete medium. Results are representative of three donors. All measurements were taken in triplicate.
Specifications
Storage
PRIME-XV MSC XSFM Supplement is shipped with dry ice. Upon receipt, store the supplement at or below -20°C in a manual defrost freezer and protect from light. PRIME-XV MSC XSFM Base (+) or (-) Phenol Red is shipped at 2-8˚C with cold packs. Upon receipt, store PRIME-XV MSC Base (+) or (-) Phenol Red at 2-8°C in a refrigerator and protect from light.
Shelf Life
Handle using aseptic techniques to avoid contamination. Unopened liquid medium is stable for 12 months from date of manufacture, as indicated on the label. After mixing the two components, the complete media is equivalent to catalog part number 91149 PRIME-XV MSC Expansion XSFM and can be aseptically aliquoted and stored at or below -20°C in a manual defrost freezer for up to 3 months.
