Table 1 Stability profiles of current (or formerly) marketed AAV poducts7,8,9,10.
From: Thermostability and in vivo performance of AAV9 in a film matrix
Glybera (alipogene tiparvovec)7 | Luxterna (voretigene neparvovec-rzyl)8 | ||
|---|---|---|---|
Serotype | AAV1 | AAV2 | AAV9 |
Indication | Lipoprotein Lipase Deficiency (LPLD) | Biallelic RPE65 mutation-associated retinal dystrophy | Spinal Muscular Atrophy (SMA) with mutations in the SMN1 gene |
Storage | −25 to −15 °C | −80 °C | −80 °C |
Formulation | Phosphate buffered saline Sucrose WFI | 180 mM NaCl 10 mM sodium phosphate (pH 7.3) 0.001% Poloxamer 188 | 20 mM Tris (pH 8.0) 1 mM MgCl2 200 mM NaCl 0.005% Poloxamer 188 |
Shelf Life | 18 mo −25 to −15 °C | 2 years −80 °C | 12 mo −80 °C |
Shelf Life Thawed Other Instructions | 8 h 2–8 °C 8 h RT Protect from light | Prepare and use within 4 h Do not refreeze | Store at 2–8 °C upon receipt. 14 d 2–8 °C Use within 8 h after drawing into syringe Do not shake. |
