Table 2.

Release Specification and Assay Results of cGMP GPRTG-EF1α-hγ_c-OPT LVVs

Parameter	Specification (tu/mL Based on ED7R Titer Unless Otherwise Indicated)	Result in Clinical Vector	Result in iCELLis Nano-Produced Vector
Purified GRPTG-EF1α-hγc-OPT LVVs
Container integrity	intact vial, no particulates, solution clear and colorless	intact vial, no particulates, solution clear and colorless	not performed
Sterility	sterile	sterile	sterile
Bacteriostasis and fungistasis	no bacteriostatic and fungistatic activity	no bacteriostatic and fungistatic activity	not performed
Endotoxin	<5.0 EU/mL	<0.05 EU/mL	1.77 EU/mL
Infectious titer (HOS)	≥2 × 108 tu/mL	5.2 × 108 tu/mL	not performed
γ Chain expression/infectious titer (ED7R)	≥1 × 108 tu/mL	3.32 × 108 tu/mL	2.3 × 108 tu/mL
Residual host cell protein HEK293T	<7 ng/107 tu	7 ng/107 tu	2.3 ng/107 tu
Residual host cell DNA	≤26 ng/107 tu	13 ng/107 tu	120 ng/107 tu
Residual bovine serum albumin	≤39 ng /107 tu	17 ng/107 tu	54.1 ng/107 tu
Residual Benzonase	≤0.026 ng/107 tu	<0.006 ng/107 tu	<0.009 ng/107 tu
Vector insert integrity by sequence	consistent with expected results	consistent with expected results	not performed
SV40 large T antigen DNA sequence transfer	not detected	not detected	not performed
Limit for In Vitro Cell Age for Production
In vivo assay for the presence of inapparent viruses	negative	negative	not performed
Vector insert integrity by DNA sequence in the producer cell line	consistent with expected result	consistent with expected result	not performed
TEM of cultured cells	no identifiable viral particles other than expected lentivirus-like particles	no identifiable viral particles other than expected lentivirus-like particles	not performed
Cell line identity by CO1 barcode	consistent with human origin	consistent with human origin	not performed

EU, endotoxin units.