Gibco™

CTS™ Essential 8™ Medium

Catalog number:  A2656101

Related applications:

Cell & Gene Therapy

| Stem Cell Culture

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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.

For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals.

Specifications

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

Contents & storage

• 500 mL CTS Essential 8 Medium, store at 2–8°C, protect from light
• 10 mL CTS Essential 8 Supplement, store at −5°C to −20°C, protect from light