Cell mediated gene therapy: A guide for doctors in the clinic

Table 3 Suggested release tests advised by Food and Drug Administration for cell product

Category	Test	Key measurement
Sterility	Sterility	Microbiological testing
	Mycoplasma	After pooling of cultures but before washing
Identity	Identity	Cell identity and assess heterogeneity
Purity	Impurity	Residuals contaminants
	Endotoxin	Contaminants during the process
Potency	Specific to product	Relevant function of the cells
Other testing	General safety	Cellular therapy products are exempt
	Viability	Generally > 70%
	Cell number	Minimum and maximum cell number
Title 21 of the code of federal regulations applied to cell therapy products
The tissue rules: Part 1271
The biologics requirements: Part 600 and 610
The investigational new drug requirements: Part 312
The drug manufacturing requirements: Parts 211 and 212