Gibco™ CTS™ PSC Cryopreservation Kit

The CTS PSC Cryopreservation Kit is cGMP manufactured and used for the cryopreservation and recovery of pluripotent stem cells (PSCs).

Supplier:  Gibco™ A4239301

Catalog No. A4239301

Description

The CTS PSC Cryopreservation Kit is cGMP manufactured and used for the cryopreservation and recovery of pluripotent stem cells (PSCs). The kit consists of CTS PSC Cryomedium, a xeno-free solution for the cryopreservation of early passage PSCs, and CTS RevitaCell Supplement (100X), a chemically defined recovery supplement for use in the post-thaw culture medium. In combination, these reagents help minimize loss of cell viability, maximize post-thaw recovery, and minimize unwanted differentiation of pluripotent stem cells.

The CTS PSC Cryopreservation Kit:
• Provides efficient recovery and higher viability than traditional methods of PSC cryopreservation
• Facilitates regulatory filings through cGMP manufacturing and the availability of documentation
• Simplifies the transition from bench to clinic through the direct replacement of the RUO PSC Cryopreservation Kit

Efficient recovery
The CTS PSC Cryopreservation Kit achieves higher viability than traditional methods of cryopreservation. It is compatible with clump and single cell passaged PSCs cultured in a variety of media systems. CTS PSC Cryomedium is provided as a ready-to-use, complete solution containing 10% DMSO for efficient cell addition. Separate additions of enhancing reagents are not required, helping save valuable preparation time.

Facilitates regulatory filings
The CTS PSC Cryopreservation Kit is manufactured at a site that uses methods and controls that conform with cGMP for medical devices, 21 CFR Part 820. Our FDA-registered manufacturing site is ISO 13485-certified. Full documentation traceability and convenient access to our Drug Master File (DMF) are available for the CTS PSC Cryopreservation Kit.

Simplifies transition from bench to clinic
The CTS PSC Cryopreservation Kit provides the same efficient recovery, consistency, and reduced variability as the RUO PSC Cryopreservation Kit. With its additional safety testing, including adventitious agents, the CTS PSC Cryopreservation Kit enables a smooth transition from the RUO PSC Cryopreservation Kit.

Specifications

• Content And Storage: • 50 mL CTS PSC Cryomedium; store at –5 to –20°C and protect from light
  • 5 mL CTS RevitaCell Supplement (100X); store at –5 to –20°C and protect from light
• Classification: Xeno-free
• Product Type: Cryopreservation Medium
• With Additives: DMSO (10%)
• For Use With (Application): Cell and Gene Therapy Research, Development, and Manufacturing
• Quantity: 1 kit

• Cell Type: Embryonic Stem Cells (ESCs), Induced Pluripotent Stem Cells (iPSCs)
• Form: Liquid
• Sterility: Sterile-filtered
• Format: Bottle
• Manufacturing Quality: ISO 13485, MDSAP, FDA-registered, 21 CFR 820
• Shipping Condition: CTS PSC Cryomedium: Dry Ice
  CTS RevitaCell: Dry Ice

Safety and Handling

ShelfLife : 12 months from date of manufacture

WARNING: Reproductive Harm - www.P65Warnings.ca.gov

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