Gibco™ CTS™ StemScale™ PSC Suspension Medium

Descrizione

CTS (Cell Therapy Systems) StemScale PSC Suspension Medium is the first commercially available medium specifically developed for scalable suspension culture of pluripotent stem cells (PSCs) for clinical manufacturing and commercialization of PSC-derived therapies. With an optimized and easy-to-use protocol, coupled with a xeno-free formulation, CTS StemScale medium provides a fast, easy, and cost-effective solution for scaling from translational studies to clinical manufacturing.  PSCs expanded in CTS StemScale medium maintain pluripotency and genomic stability across multiple passages and can be differentiated to the three germ layers. 

CTS StemScale PSC Suspension Medium provides:

• Maximal expansion capability versus other PSC suspension media, helping reduce manufacturing time and cost
• Scalable expansion of PSCs for clinical manufacturing and automation platforms
• Improved cell viability and yield with an optimized protocol
• Cell therapy manufacturing with extensive product safety and quality testing, GMP manufacturing, traceability of raw materials, and regulatory documentation
• PSC suspension culture intellectual property (IP)

Maximal expansion capability
PSCs cultured in CTS StemScale medium can achieve 5–10-fold expansion per passage and up to 30% higher expansion versus other PSC suspension media.  Long-term expansion of PSCs in CTS StemScale medium (>30 passages) can be accomplished without the loss of expansion potential, pluripotency, or genomic stability. 

Scalable expansion
CTS StemScale medium promotes consistent growth of PSCs in plates, flasks, and bioreactors.  PSCs can be efficiently expanded in CTS StemScale medium across vessel types using the same culture parameters at both small and large scales.

Optimized protocol
CTS StemScale medium promotes spheroid nucleation of both induced pluripotent stem cells (iPSCs) and embryonic stem cells (ESCs).  PSCs grown in CTS StemScale medium are fed by a 50% medium replacement strategy. This method reduces metabolic waste build-up while maintaining consistent media volumes in the culture, a critical factor in the maintenance of spheroid size.  During passaging, the use of cell strainers is not required when dissociating the PSC spheroids, thereby helping minimize cell loss and improving cell viability while supporting maximal expansion of PSCs.

GMP manufactured
Gibco CTS products are 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. Specific intended-use statements, full documentation traceability, and convenient access to our Drug Master File (DMF) are available for CTS StemScale PSC Suspension Medium.

PSC suspension culture IP

CTS StemScale is the only commercially available PSC culture medium that provides customers rights to Thermo Fisher’s exclusively licensed foundational intellectual property for culturing and expanding PSCs in suspension.