Thermo Fisher, A5869601, CTS™ StemScale™ PSC Suspension Medium

Quantity: 1 L 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 costScalable expansion of PSCs for clinical manufacturing and automation platformsImproved cell viability and yield with an optimized protocolCell therapy manufacturing with extensive product safety and quality testing, GMP manufacturing, traceability of raw materials, and regulatory documentationPSC suspension culture intellectual property (IP)Maximal expansion capabilityPSCs 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 expansionCTS 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 protocolCTS 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 manufacturedGibco 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 IPCTS 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.
Cell Type: Embryonic Stem Cells (ESCs), Induced Pluripotent Stem Cells (iPSCs)
Concentration: 1X (CTS StemScale Basal Medium), 10X (CTS StemScale Supplement)
For Use With (Application): Cell and Gene Therapy Research, Development, and Manufacturing
Format: Bottle
Manufacturing Quality: ISO 13485, MDSAP, FDA-registered, 21 CFR 820
Product Type: Cell Culture Medium
Quantity: 1 L
Shelf Life: 12 Months from Date of Manufacture
Shipping Condition: Ambient (CTS StemScale Basal Medium), Dry Ice (CTS StemScale Supplement)
Classification: Xeno-free
Culture Type: Suspension Cell Culture, Stem Cell (Human, iPS - Induced Pluripotent Stem, Embryonic)
Form: Liquid
Serum Level: Serum-free
Sterility: Sterile-filtered
Sterilization Method: Sterile-filtered
Without Additives: No Phenol Red
Unit Size: Each