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The Stem Cells We Use

Author Admin Views Posted at 2011/11/04

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 to suspension evenly, precipitaes not obviously, does not have the foreign matter

Pass

Volume

Should be 20±2ml/per bag

Pass

Cell Number

1.0-2.0×107 cells/per bag

Pass

Cell Livability

Should be 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 95%. CD 31, CD 34, CD 45, HLA-DR should be negative, the positive rate should be 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 2EU/ml

Pass

FBS Residual Quantity

Should be 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

 

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