,Test,Material,Specification,Result
0,Sterillity test,Vialled,Pass,Pass
1,,product,,
2,Mycoplasma,Bulk harvest,Negative,Negative
3,,lot,,
4,Spiroplasma,Bulk harvest,Negative,Negative
5,,lot,,
6,Viral contamination in vitro: 28-day assay for detection of viral,Bulk harvest,Negative,Negative
7,"contaminants using three detector cell lines (MRC5, Vero, and",lot,,
8,C6/36),,,
9,Viral contamination in vitvo: test for presence of inappropriate,Bulk harvest,Negative,Negative
10,"viruses using suckling mice, adult mice, and guinea pigs",lot,,
11,Abnormal toxicity test,Vialled,Pass,Pass
12,,product,,
13,Endotoxin,Vialled,<1400 EU/mL,0.482 EU/mL
14,,product,,
15,Protein concentration,Vialled,>0.15 mg/mL,0.174 mg/mL
16,,product,<1.0 mg/mL,
17,Appearance,Vialled,"Clear, colorless solution essentially free",Pass
18,,product,of visible particles,
19,pH,Vialled,Formulation buffer +/- 1.0 pH unit,pH 7.14
20,,product,,
21,Osmollality,Vialled,200-600 mOsMol/kg,319 mOsMol/kg
22,,product,,
23,Residual host-cell DNA,Bulk product,<10 ng per dose,<180.0 pg/mL
24,Residual host-cell protein by western blot,Bulk product,Report result,Negative
25,Residual C-tag ligand,Bulk product,<1mg/mL,<2ng/mL
26,Copia gag western blot,Bulk product,For information only,Negative for copia protein
27,,,,at ~31kDa
28,Identity by western blot,Vialled,Positive for RHS.1,Positive for RHS.1
29,,product,,
30,Purity by SDS-PAGE,Vialled,RHS.1 bands >90% of total bands,>95%
31,,product,detected,
32,HPLC-SEC,Vialled,For information only,Pass
33,,product,,
