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Cell-Based Products
Characterization and Release Testing

EMO provides Quality Control test items as below for in-process QC and Product release. If you need other test services, refer to Column and Column Ⅴ please.

● Safety & Purity ※ (ISO 17025 Certificated)

● Sterility testing

○ Direct Inoculation

– Compliant with USP<71> and Chinese Pharmacopeia (7001)
– Method suitability test (FTM: S. aureus、P. aeruginosa、C. sporogenes;SCD/TSB: B. subtilis、C. albicans、A. Brasiliensis)

● Mycoplasma Testing

○ PCR (Detection limit: 10 CFU/mL)
○ Real-time PCR (Detection limit: 10 CFU/mL)

– Compliant with EP 2.6.7 and Chinese Pharmacopeia (7009)

● Endotoxin Testing

○ Kinetic-chromogenic technique (Detection limit: 0.01 EU/mL)

– Compliant with USP<85> and Chinese Pharmacopeia (7008)

● Identity

● Cell Surface Marker Analysis

○ Lymphocyte
○ Mesenchymal Stem Cell

● Biological / Potency Assay

● NK Cytotoxicity
● Immunopotency Assay of MSCs

○ IDO Quantification Assay

– IDO is on Important Enzyme on MSCs to Inhibit Immune Cells
– For MSCs Product Releasing etc.

○ Suppression of T Cell Proliferation Assay

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