HUAREN MEDICAL TECHNOLOGY

R & D SERVICES

Cell release criteria

Quality standards for stem cell preparations

Testing items		Standard regulations
Cell identification	Morphology	Growing in a long shuttle shape and vortex like pattern
Cell identification	Cell surface markers	CD73+ ≥95%，CD105+ ≥95%，CD90+ ≥95%，CD45+ ≤2%，CD34+ ≤2%， CD11b+ ≤2%，CD19+ ≤2%，HLA-DR+ ≤2%。
Appearance of the preparation	Appearance	It is a colorless, light white or light yellow liquid with no visible foreign matter (such as sediment, flocs, etc.) to the naked eye
Cell viability	Taipan Blue Dyeing calculates the activity rate	≥95％
VIRUS	Human source virus detection	Hepatitis B virus, hepatitis C virus, syphilis, HIV, cytomegalovirus and herpes simplex virus are all negative
Fine and fungal detection	Bacteria detection	Feminine
	Fungal detection	Feminine
	Endotoxin test	<0.5EU/mL
Mycoplasma testing	PCR detection method	Feminine

Quality standards for immune cell preparations

Testing items		Standard regulations
Appearance of the preparation	Appearance	As a light white or light yellow liquid
Cell viability	Taipan Blue Dyeing calculates the activity rate	≥95％
VIRUS	Human source virus detection	Hepatitis B virus, hepatitis C virus, syphilis, HIV, cytomegalovirus and herpes simplex virus are all negative
Fine and fungal detection	Bacteria detection	Feminine
	Fungal detection	Feminine
	Endotoxin test	<0.5EU/mL
Mycoplasma testing	PCR detection method	Feminine

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Guangxi Huaren Medical Technology Group Co., Ltd.

Address: 15th Floor, Building A, Biyuan Center, Wuxiang New District, Nanning City, China (Guangxi) Pilot Free Trade Zone

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