Mehdi Gasmi, PhD

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AAV-Bac: Conclusions‣Easy scale up, up to Nx200L‣No serum=> better safety risk profile‣Vector quality similar to transfection production‣Process already approved for registered product‣One extra raw material to make (MVB, >3 mo.) and control•Compared with plasmid transfection
Comparison rAAV transfection vs. rAAV-BacCriteriaTransfectionBaculovirussystemScale-up No YesPurity Profile of DP Good GoodValidation Potential Poor HighMfg costs(Low demand)Mfg costs(High demand)$ $$$*$$$ $*Regulatory (Quality) OK for PhI/II (serum) Approved (EU)ConclusionVery cumbersomeprocess but useful toget to the clinic fast.Difficult to go pastearly phases ofdevelopmentBetter option forhigh-doseindications. Longerlead-time fromtransgene to product(MVB)
Page 1 and 2: Improvements towards the industrial
Page 3 and 4: AAV vectors in the clinic‣~30% pr
Page 5 and 6: Transfection for rAAV production at
Page 7 and 8: Transfection in suspension: lack of
Page 9 and 10: Baculovirus Technology‣rAAV produ
Page 11 and 12: AAV -Bac systemSf9 MCB/WCBAmplifica
Page 13: vg titer (vg/mL)rAAV-Bac: YieldsRes
Page 17 and 18: Detailed presentation of Genethon

Mehdi Gasmi, PhD

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