De‑risking AAV scale‑up: process comparability data from a 50 m² fixed‑bed model

Can a 50 m² fixed-bed bioreactor stand in for a 500 m² AAV manufacturing process? Manufacturing science and technology (MS&T) engineers at Novartis Gene Therapies ran five batches on the iCELLis™ platform to find out, comparing process parameters and bulk harvest titers across scales at a fraction of the cost of a manufacturing run. One unplanned transfection deviation was followed by a 48% higher bulk harvest titer. 

What you will learn

01

How Novartis Gene Therapies used a Quality by Design framework to decide which process parameters to match, and which to compromise, when scaling down an adherent AAV process

02

Why falling film height, rather than linear speed, became the main lever for dissolved oxygen control at 50 m²

03

How biomass capacitance flagged a seeding deviation early in a run, before it could affect downstream performance

Key interests

AAV manufacturing Scale-down modelling Fixed-bed bioreactor Process comparability Quality by Design Biomass capacitance Scale-up Upstream processing

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