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|
|Endotoxin testig||<12 EU/mL||<1 EU/mL|
|qPCR mycoplasma testing||N/A|
|USP sterility testing|
|H9 performance assay|
|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.
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).
PSCs cultured in the CTS Essential 8 formulation have been shown to generate the three germ lineages.
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 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.