• Six clinical trials on MSCs approved by US FDA
    Six clinical trials on MSCs approved by US FDA
  • One of the few companies manufacturing both hMSC and hNSC
    One of the few companies manufacturing both hMSC and hNSC
  • First FDA-approved clinical trial using stem cells to treat Alzheimer’s
    First FDA-approved clinical trial using stem cells to treat Alzheimer’s
  • MSCs approved as a treatment of AMI in Kazakhstan
    MSCs approved as a treatment of AMI in Kazakhstan
  • Producing clinical-grade stem cells with strong activity in large scale
    Producing clinical-grade stem cells with strong activity in large scale
  • SCF activity preserved through patented technology for 3 years
    SCF activity preserved through patented technology for 3 years

Add:21st Floor, Block 1, Jusha Center, No.16 Xinyuanli, Chaoyang District, Beijing

Phone: 86-10-64654791

 

 

Copyright ©Jiuzhitang Maker (Beijing) Cell Technology Co., Ltd.! 

京ICP备19006400号-1     Powered by 300.cn

Technology

Technology Platform

Page view:
 

1.US FDA cGMP-compliant manufacturing processes guarantee product safety
2.Large scale and standardized production of stem cells
3.Launched 8 clinical trials in the US and 11 in other countries
4.Approved by Kazakhstan government as a treatment of medical conditions
5.Selected as “Best-in-Class” product by Life Technologies

Large-scale production of clinical

grade stem cell drugs with high

activity

US FDA cGMP-compliant

manufacturing processes guarantee

product safety

Jiuzhitang Maker will bring in cutting-edge stem cell pharmaceutical

technologies developed by Stemedica Cell Technologies, Inc. At

present, Jiuzhitang Maker is building its 4500㎡ R&D and

manufacturing facility in ZGC Biomedicine Industry Park, Daxing District,

Beijing. The facility will be constructed following EU cGMP standards

and is estimated to become operational in 2019. It will be dedicated to

manufacturing of allogenic bone marrow-derived mesenchymal stem

cells and neural stem cells. By following manufacturing processes in

compliance with regulatory requirements of FDA, the innovative

manufacturing platform successfully achieved cutting-edge scalability

for stem cell production and solved key technical issues involved in

making stem cells into drugs, without compromising the safety profile

and therapeutic efficacy of stem cells.

 

Technical Advantages

Stemedica Cell Technologies, Inc. has launched 19 clinical studies on its stem cell products. Among these clinical programs, a Phase III clinical

study using ischemia-tolerant bone marrow mesenchymal stem cells to

treat acute myocardial infarction has been completed at National

Medicine and Science Center of Kazakhstan and obtained approval

granted by Ministry of Health of Kazakhstan as a treatment of this

condition.

Stem cells produced via this platform were selected as “Best-in-Class”

products by Life Technologies, a famous life sciences company.