cts-essential8-medium-showcase2

Make the seamless transition from bench to clinical applications

CTS Essential 8 Medium is the only globally available human pluripotent stem cell (hPSC) culture medium without components derived directly from animals. Based on the widely cited Essential 8 Medium, CTS Essential 8 Medium offers a seamless transition from the bench to the clinic.

  • Reduces risk–fully defined, with components not directly derived from animals
  • Facilitates regulatory filings–cGMP-manufacturing and regulatory documentation available, including FDA Drug Master File
  • Provides seamless transition–same formulation, benefits, and performance as research-use Essential 8 Medium, but with components not directly derived from animals

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.

Feature Essential 8 Medium CTS Essential 8 Medium
FDA Frug Master File N/A
 
Regulatory risk assessment N/A  
Full traceability N/A  
Endotoxin testig <12 EU/mL <1 EU/mL
qPCR mycoplasma testing N/A  
USP sterility testing    
H9 performance assay    
cGMP manufacturing     
Intented use statement For Research Use Only. Not for use in diagnostic procedures. For Research Use or Manufacturing of Cell, Gene, or Tissue-Based Products. Caution: Not intented 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.
 

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.

Culture medium

Passaging reagent

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.