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Gibco™ CTS™ PSC Cryomedium
Description
CTS PSC Cryomedium is a cGMP-manufactured, ready-to-use, xeno-free solution for the cryopreservation of early passage pluripotent stem cells (PSCs). It helps minimize loss of cell viability and maximize post-thaw recovery. For the cryopreservation and recovery of PSCs, use the CTS PSC Cryopreservation Kit, which includes CTS PSC Cryomedium and CTS RevitaCell Supplement.
CTS PSC Cryomedium:
- 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 RUO PSC Cryopreservation Medium
Efficient recovery
CTS PSC Cryomedium routinely achieves higher viability than traditional methods of cryopreservation and is compatible with clump and single cell passaged PSCs cultured in a variety of media systems. It 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
CTS PSC Cryomedium 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 CTS PSC Cryomedium.
Simplifies transition from bench to clinic
With its extensive safety testing, including adventitious agents, CTS PSC Cryomedium enables a smooth transition from RUO PSC Cryopreservation Medium.
Specifications
Specifications
| Cell Type | Embryonic Stem Cells (ESCs), Induced Pluripotent Stem Cells (iPSCs) |
| Classification | Xeno-free |
| Form | Liquid |
| Product Type | Cryopreservation Medium |
| Sterility | Sterile-filtered |
| With Additives | DMSO (10%) |
| For Use With (Application) | Cell and Gene Therapy Research, Development, and Manufacturing |
| Manufacturing Quality | ISO 13485, MDSAP, FDA-registered, 21 CFR 820 |
| Quantity | 50 mL |
| Shipping Condition | Dry Ice |
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Frequently Asked Questions (FAQs)
The Gibco Cell Therapy Systems (CTS) portfolio of cell and gene therapy products are GMP manufactured, safety tested, and backed by regulatory documentation to support your transition from discovery through clinical and commercial manufacturing. Through our CTS solutions, we are committed to helping customers streamline therapeutic development, minimize risk, and ease the burden on their quality systems. Learn more here.
The CTS PSC Cryopreservation Kit (Cat. No. A4239301) provides the same efficient recovery, consistency, and reduced variability as the PSC Cryopreservation Kit (Cat. No. A2644601). However, these two kits have different intended use statements, i.e., “For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals” and “For Research Use Only”, respectively. Furthermore, the CTS PSC Cryopreservation Kit has full USP sterility testing info and a Drug Master file (DMF), whereas the sterility testing of the PSC Cryopreservation is via a modified USP method, and it does not have a DMF.
For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals.