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Make the seamless transition from bench to clinical applications

CTS Essential 8 Medium is the first globally available animal-origin free hPSC culture medium designed to meet international regulatory requirements. Based on the widely cited Essential 8 Medium, CTS Essential 8 Medium offers a seamless transition from the bench to the clinic.

  • Fully defined, animal and human origin–free
  • cGMP grade and tested for adventitious agents
  • Regulatory documents are available (e.g., FDA Drug Master File)

Gibco PSC Media are manufactured according to cGMP for medical devices, 21 CFR Part 820

Cell therapy–grade Essential 8 Medium for clinical applications

CTS (Cell Therapy Systems) Essential 8 Medium is an animal-origin free (AOF) and feeder-free medium specially formulated for the growth and expansion of human pluripotent stem cells (PSCs). Originally developed by Guokai Chen et al. in the laboratory of James Thomson (published as "E8") and validated by Cellular Dynamics International, Essential 8 Medium has been extensively tested and proved to maintain pluripotency in multiple iPSC lines. In addition, Essential 8 Medium has been used to scale up production of iPSCs and shown to support iPSC growth for >50 passages without any signs of karyotypic abnormalities, along with maintaining the ability of iPSCs to differentiate into all three germ line lineages. CTS Essential 8 Medium is our next-generation Essential 8 Medium. The human origin components have been replaced with recombinant components resulting in a completely AOF (at the primary component level) medium.

Table 1. Features of Essential 8 Medium vs. CTS Essential 8 Medium.

Features of Essential 8 Medium versus CTS Essential 8 Medium

Designed to meet global regulatory standards

CTS Essential 8 Medium has replaced the human-origin components with recombinant proteins resulting in the first globally available AOF, feeder-free, GMP manufactured product. CTS Essential 8 Medium is based on the original Essential 8 Medium formulation and exhibits comparable performance. This provides a seamless transition from early development through the clinical research phase. Each lot is qualified using a validated QC assay on a PSC line, helping to ensure acceptable performance. Lot testing also includes mycoplasma, endotoxin and USP sterility to minimize contamination risk.
 

Long-term maintenance of PSC cultures

PSCs have been shown to maintain PSC marker expression after long-term culture in the CTS Essential 8 formulation.

PSC markers Oct4 and SSEA4

Figure 1. PSC marker expression. PSCs were cultured in CTS Essential 8 Medium for over 30 passages and then stained using the Invitrogen PSC 4-Marker Immunocytochemistry Kit. PSCs exhibit strong expression of the PSC markers (A) Oct4 (red) and (B) SSEA4 (green) against a DAPI counterstain (blue).

Differentiation potential

PSCs cultured in the CTS Essential 8 formulation have been shown to generate the three germ lineages.

Trilineage differentiation via directed differentiation

Figure 2. Trilineage differentiation via directed differentiation. PCSs were cultured in CTS Essential 8 Medium and differentiation was induced using the following lineage-specific differentiation kits: (A) Gibco PSC Definitive Endoderm Induction Kit, (B) Gibco PSC Cardiomyocyte Differentiation Kit, (C) Gibco PSC Neural Induction Medium, and (D) Gibco Dopaminergic Neuron Differentiation Kit. The proper lineage is shown by (A) CXCR4 staining for definitive endoderm differentiation, (B) TNNT2 and NKX2.5 staining using the Invitrogen Human Cardiomyocyte Immunocytochemistry Kit for cardiomyocyte differentiation, (C) Nestin and Sox2 using the Invitrogen Human Neural Stem Cell Immunocytochemistry Kit for neural stem cell differentiation, and (D) OTX2 and FOXA2 using the Invitrogen Human Dopaminergic Neuron Immunocytochemistry Kit for midbrain floor plate differentiation.
 

Seamless transition from research-use Essential 8 Medium

PSCs cultured in CTS Essential 8 Medium have been shown to be comparable to PSCs cultured in research-use Essential 8 Medium.

Figure 3. Comparison of PSC marker expression. PSCs were cultured in Essential 8 or CTS Essential 8 Medium. At passage three, cells staining positive for PSC markers were quantified over total number of cells to obtain % marker expression. High percentages of cells expressed PSC markers whether cultured in research-use Essential 8 Medium or CTS Essential 8 Medium.

Complete media system

The following components are recommended to create a complete media system for seamless transition of PSCs from bench to clinical research with CTS Essential 8 Medium.

CTS Essential 8 Medium protocol

Culture medium

Matrix

Passaging reagent

Resources

Support

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CTS Essential 8 Medium: For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. CAUTION: Not intended for direct administration into humans or animals. View product pages for intended use of all other products.