Quality control of clinical cell culture laboratory

doi:10.3877/cma.j.issn.2095-5820.2019.03.010

Abstract

Abstract:

With the development of biotherapeutic technology, cell products have become a new bright spot in the treatment of some major refractory diseases. Since cells need to be cultured and amplified in the laboratory prior to clinical application, quality standards should be defined in every relevant link. According to the characteristics of cell culture preparation products, this paper puts forward the quality control ideas of cell culture laboratory. It systematically expounds the quality control criteria of cell production, auxiliary materials for cell preparation products, preparation process control and cell quality control. Through continuous improvement of quality management, cell industry can be promoted and the order develops healthily.

Key words: Cell preparation, Quality study, Quality control, Cell culture

Weiqun Sun, Jinyang Chen, Junquan Liu. Quality control of clinical cell culture laboratory[J]. Chinese Journal of Clinical Laboratory Management(Electronic Edition), 2019, 07(03): 173-179.

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