Home > About Us > Article Content

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
Inspector:Ying Guo     QC Director: Yongju Liu     Date:2009.04.13
-----------------------------------------

Related Information:

    Tel: +86-10-83614168 Fax: +86-10-83614989 Email:  inquiry@wumedicalcenter.com
    Add:198 Fengbao Road, Beijing, China Zip:100160  Contact Us 
    Copyright@2013 Runde Healthcare Consulting Limited. 
    abuse@anti-spam.cn