Anacura

Batch release

Identity

Surface marker determination
Bioassay
Biochemical marker

Purity

Percentage of viable cells
Percentage of cells expressing specific markers
Limits on undesired cell types
Limits on process contaminants
Endotoxin

Potency

Viable cell number
Colony-formation assay
Change in expression of specific genes
Secretion of desired macromolecule
Evidence of metabolic activity
Evidence of cell function

Dose

Viable cell number
Enumeration of specific cell population

Sterility

Mycoplasma-cell-based-batch

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