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Gibco™ CTS™ NK-Xpander™ Medium
Description
Gibco CTS NK-Xpander Medium is specifically formulated for superior expansion of human natural killer (hNK) cells for cell therapy applications. When hNK cells are enriched from human peripheral blood mononuclear cells (hPBMCs) and expanded in a feeder-free system using CTS NK-Xpander Medium supplemented with 5% hAB serum and 500U/mL IL-2, ≥90% of the hNK cells generated maintain CD56+/CD16+/CD3- surface marker expression. Furthermore, such hNK cells demonstrate degranulation and killing of K562 cancer cells when expanded in CTS NK-Xpander Medium.
Superior expansion potential
CTS NK-Xpander Medium is capable of producing a high yield of hNK cells without the need for feeder cells, providing robust expansion of enriched hNK cells from hPBMCs from qualified donors at day 14 to 15 versus other medium options. Cells maintain CD56+/CD16+/CD3- surface marker expression and demonstrate cytolytic capabilities when expanded in CTS NK-Xpander Medium.
Manufactured for cell therapy applications
CTS NK-Xpander Medium is manufactured without cytokines and growth factors to allow flexibility with regard to intended application. The medium does not include human or animal-derived components; however, supplementation with hAB serum is recommended for best results.
CTS quality
Gibco CTS products follow USP <1043> ancillary materials for cell, gene, and tissue-engineered products within the responsibilities applicable to a supplier.* Documentation such as specific intended-use statements, full documentation traceability, and convenient access to our Drug Master File (DMF) are available to support your regulatory filing.
The products are manufactured at a site that uses methods and controls that conform to cGMP for medical devices, 21 CFR Part 820. Our FDA-registered manufacturing sites are ISO 13485-certified.
Closed-system compatibility
CTS NK-Xpander Medium is available in 500-mL-bottle and 5-L-bag formats for convenient process development and closed-system manufacturing scale-up. The 5-L bioprocess container chamber is constructed from Aegis 5-14 film and includes sterile, weldable DEHP-free PVC tubing with Luer lock and C-Flex™ tubing with MPC quick connector providing versatile connection options for your manufacturing process, including compatibility with the CTS Rotea Counterflow Centrifugation System.
*Other aspects of USP <1043> will be the responsibility of the end-user to assess. Thermo Fisher Scientific cannot fulfill USP <1043> in regards to application and therapy-specific aspects (e.g., residual assessment and removal of the AM).
Specifications
Specifications
| Cell Type | Natural Killer (NK) cells |
| Form | Liquid |
| Product Type | Cell Culture Medium |
| Serum Level | Serum-free |
| Sterility | Sterile-filtered |
| For Use With (Application) | Cell and Gene Therapy Research, Development, and Manufacturing |
| Manufacturing Quality | ISO 13485, MDSAP, FDA-registered, 21 CFR 820 |
| Quantity | 500 mL |
| Shipping Condition | Basal: Ambient, Supplement: Dry Ice |
| Format | Bottle |
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Frequently Asked Questions (FAQs)
Yes. Customer data have shown that CTS NK-Xpander Medium is capable of proliferating NK cells in feeder culture systems; however, as it has not been tested for use with feeder cells in-house, we recommend optimization for best results.
Yes. Customer data has shown that CTS NK-Xpander Medium is capable of proliferating NK cells using 5% CTS Immune Cell Serum Replacement (SR) (Cat. No. A2596101, A2596102) with modified K562 feeder cells; however, this protocol has not been optimized in-house.
Yes. Combinations of IL-2, IL-15, and IL-21 were tested with CTS NK-Xpander Medium; however, alternative combinations were not found to affect performance or functionality. We recommend supplementation with IL-2 only.
No. Unlike cytotoxic T cells, activation beads are not required for NK cell proliferation.
No. CTS NK-Xpander Medium is manufactured under animal origin-free (AOF) conditions; however, we recommend supplementation of CTS NK-Xpander Medium with human AB serum for best results.
For Research Use or Manufacturing of Cell, Gene, or Tissue- Based Products. CAUTION: Not intended for direct administration into humans or animals.
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