描述

CTS Essential 8 Medium is an animal-origin-free (AOF), feeder-free medium formulated for the growth and expansion of both embryonic and induced human pluripotent stem cells (PSCs). Essential 8 Medium is the most defined PSC medium as described in the original publication by Guokai Chen et al. in the laboratory of James Thomson. CTS Essential 8 Medium enables the transition from bench to clinic through the direct replacement of research-use-only (RUO) Essential 8 Medium.

CTS Essential 8 Medium:
• Reduces the risks associated with animal origin material through an AOF formulation and adventitious agent testing
• Facilitates regulatory filings through cGMP manufacturing and the availability of documentation
• Simplifies the transition from bench to clinic with the same 8-component formulation as RUO Essential 8 Medium, but with AOF components

Reduces risks from animal-origin material
CTS Essential 8 Medium contains no animal- or human-derived components at the primary component level, and is additionally tested for adventitious agents, thereby reducing the risks associated with animal-origin components. It is the only commercially available AOF medium for pluripotent stem cell culture: Competitors’ similar-grade products are only xeno-free, containing human serum albumin (HSA), which brings additional risks in a clinical environment.

Facilitates regulatory filings
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- and ISO 9001-certified. Specific intended-use statements, full documentation traceability, and convenient access to our Drug Master File (DMF) are available for CTS Essential 8 Medium.

Simplifies transition from bench to clinic
Like RUO Essential 8 Medium, CTS Essential 8 Medium contains only the eight essential components needed for stem cell culture, but is AOF. Combined with cGMP manufacturing, this simple, fully-defined formulation improves consistency compared to other media that contain over 20 highly variable ingredients. The close similarity between Essential 8 Medium and CTS Essential 8 Medium enables a smooth transition from one medium to the other.

CTS Essential 8 Medium is commercialized in partnership with Cellular Dynamics International.

规格

Manufacturing Quality:	cGMP for medical devices, 21 CFR Part 820 and ISO 13485
Cell Type:	Stem Cells (Embryonic), Stem Cells (Human), Stem Cells (iPS - Induced Pluripotent Stem)
Product Line:	CTS™, Essential 8™
Product Size:	500 mL
Shipping Condition:	Approved for shipment at Room Temperature or on Wet or Dry Ice

内容及储存