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中国生物工程杂志

China Biotechnology
China Biotechnology  2016, Vol. 36 Issue (10): 115-121    DOI: 10.13523/j.cb.20161016
    
The Standards and Quality Control of Cell Drug
WANG Dian-liang
Tissue Engineering and Regenerative Medicine Laboratory, The General Hospital of The PLA Rocket Force, Beijing 100088, China
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Abstract  

Cell drugs are eventually used in the human body, it is necessary to establish corresponding standards for quality control. To ensure the safety, effectiveness and stability of the product, the whole process of donor screening,tissue collection, cell separation, cell culture, cell cryopreservation, cell resuscitation, check out, transport and application must be systematically carried out. In recent years, China has gradually changed the management ideas of treating the cell therapy as the third level medical technology. On the one hand, the administrative examination and approval of already existing third level medical technology are currently cancelled. And on the other hand, stem cell transplantations are managed as drug except for autologous stem cell transplantation, and the corresponding standards and management method of quality have already been established.



Key wordsQuality control      the third level medical technology      Quality standards      Stem cell      Cell drug      Quality administration     
Received: 18 February 2016      Published: 02 March 2016
ZTFLH:  Q819  
Cite this article:

WANG Dian-liang. The Standards and Quality Control of Cell Drug. China Biotechnology, 2016, 36(10): 115-121.

URL:

https://manu60.magtech.com.cn/biotech/10.13523/j.cb.20161016     OR     https://manu60.magtech.com.cn/biotech/Y2016/V36/I10/115

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