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.!
Technology
Technology Platform
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.