Gibco™ CTS™ Essential 8™ Medium

Description

• CTS Essential 8 Medium is a fully defined 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 risks through a formulation with components not directly derived from animals • Facilitates customer regulatory filings with cGMP manufacturing, traceability of raw materials, and available documentation, including certificates of origin, drug master files, and regulatory support files • Simplifies the transition from bench to clinic with the same 8-component formulation as RUO Essential 8 Medium, but with components not directly derived from animals Reduces risks from animal-origin material CTS Essential 8 Medium contains no animal- or human-derived components at the primary component level
• It is a fully defined medium for pluripotent stem cell culture: competitors’ similar-grade products contain 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-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 with components not directly derived from animals
• 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.