Gibco™ CTS™ NK-Xpander™ Medium

Gibco CTS NK-Xpander Medium is specifically formulated for superior expansion of human natural killer (hNK) cells for cell therapy applications.

Supplier:  Gibco™ A5019002

Catalog No. A5019002

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.

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.

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

• Content And Storage: • Basal Medium: store at 2–8°C
  • Supplement: store at –20°C and protect from light
• Form: Liquid
• Serum Level: Serum-free
• Format: BPC
• Manufacturing Quality: ISO 13485, MDSAP, FDA-registered, 21 CFR 820
• Shipping Condition: Basal: Ambient
  Supplement: Dry Ice

• Cell Type: Natural Killer (NK) cells
• Product Type: Cell Culture Medium
• Sterility: Sterile-filtered
• For Use With (Application): Cell and Gene Therapy Research, Development, and Manufacturing
• Quantity: 5 L

Safety and Handling

ShelfLife : 12 months from date of manufacture

For Research Use or Manufacturing of Cell, Gene, or Tissue- Based Products. CAUTION: Not intended for direct administration into humans or animals.