The Stem Cells We Use

Author Admin Views Posted at 2013/12/29

The Stem Cells We Use

To comply with the NICPBP (National Institute for the Control of Pharmaceutical & Biological Products, SFDA) standards for clinically used stem cells, the stem cells we use for transplantation are all processed and produced in the SFDA certified GMP facilities and are inspected through our "Quality-Certificate-Approval System." This ensures the highest product quality and safety.

The following QC report is from one of our stem cell providers "Union Stem Cell & Gene Engineering Co., Ltd. " which is China´´s largest stem cell research and manufacturing company (also known as "National Industrial Base of Stem Cell Technology" ) located in Tianjin.

National Industrial Base of Stem Cells Technology

Mesenchymal Stem Cell (MSC) Manufature Department

Quality Control Report

Batch number G-09095 Date of Manufature: April 14, 2009

Inspection Item	Standard code	Inspection Result
Physical Examination		Pass
External Appearrance	Should be suspension evenly, precipitaes not obviously, does not have the foreign matter	Pass
Volume	Should be 20 add-subtract 2ml/per bag	Pass
Cell Number	1.0-2.0*107 cells/per bag	Pass
Cell Livability	Should be equal or greater than 90%	Pass
Celluar Morphology	Under microscope, the single cell should be spindle-shaped, the overall shape should be whirlpool	Pass
Cell Phenotype	CD 29, CD 44, CD 73, CD 90 and CD 105 should be positive, the positive rate should not be lowerthan 95%. CD 31, CD 34, CD 45, HLA-DR should be negative, the positive rate should be less than or equal 5%	Pass
Biological Potency	Umbilical cord MSC promotes the proliferation of single umbilical cord cell	Pass
Sterility	Should be negative	Pass
Mycoplasma	Should be negative	Pass
Endotoxin	Should be less than or equal 2EU/ml	Pass
FBS Residual Quantity	Should be less than or equal 50ng/bag	Pass
Specific Extraneous Virus	EB, CMV, HIV, HBV and HCV should be negative	Pass