cts-essential8-medium-showcase2

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)

当製品のAOF(Animal Origin Free:生物由来成分不含)の定義は一次原料に適用されます。

 

Cell therapy–grade Essential 8 Medium for clinical applications

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 has been 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 designed for the growth and expansion of hPSCs for clinical applications. The human origin components have been replaced with recombinant components, resulting in the first globally available fully defined, feeder-free, GMP manufactured medium. (Table 1).

CTS Essential 8 Medium also exhibits comparable performance (Figure 1–2). This provides a seamless transition from early development through the clinical research phase (Figure 3). 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.

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

FeatureEssential 8 MediumCTS Essential 8 Medium
FDA Frug Master FileN/A
 
Regulatory risk assessmentN/A 
Full traceabilityN/A 
Endotoxin testing<12 EU/mL<1 EU/mL
qPCR mycoplasma testingN/A 
USP sterility testing  
H9 performance assay  
cGMP manufacturing   
Intended use statementFor Research Use Only. Not for use in diagnostic procedures.For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. Caution: Not intended for direct administration into humans or animals.

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.
 

Figure 3. Using Applied Biosystems TaqMan® hPSC Scorecard Panel analysis, Gibco CTS Essential 8 Medium and research-use-only Essential 8 Medium were shown to support comparable expression of PSC markers and lineage markers in undifferentiated PSCs and PSC-derived embryoid bodies.

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.

Complete media system

The following media system is recommended to ease the transition of PSCs from stem cell therapy research to clinical applications with CTS Essential 8 Medium.

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.