Table 2.

Drug product release testing and specifications.

Product attribute	Test	Specification
Identity	Vector copy number (VCN)	0.01–5.0 copies per cell
Identity	Total number of transduced cells	0.1–5.0 x 109 cells
Identity	VCN per transduced cell	< 5 VCN/transduced cell
Identity	Frequency of Gag-specific CD4 T cells	Report results
Identity	Frequency of CD3 and CD4 cells	CD3: ≥80%; CD4: ≥50%
Purity	Cell viability	≥70%
Microbial safety	Endotoxin	< 1 EU/mL
Microbial safety	Sterility	Negative
Microbial safety	Mycoplasma	Negative
Microbial safety	Replication competent lentivirus (RCL)	Not detected
Microbial safety	HIV infectivity	Not detected (CPE)a; ≤ LLOQb (Vif RT-qPCR)
Microbial safety	Transgene mobilization	Not detected

^aCPE, cytopathic effect.

^bLLOQ, lower limit of quantitation.