Proven Linear Scale-Up for AAV9 Purification from Bench to Manufacturing Scale
Download an AAV scale-up study going from 1L to 500L using the Repligen KRM Chromatography System
Scaling chromatography processes for gene therapy manufacturing requires confidence that performance at bench scale will translate predictably to production. In a collaboration with Forge Biologics, a leading gene therapy CDMO, Repligen's KRM® 10 Chromatography System was used to successfully scale an AAV9 capture chromatography process from a 5 mL development column to a 515 mL manufacturing-scale column while maintaining consistent process performance and product quality.
The study demonstrated linear scale-up across a 100-fold increase in column volume using the same process parameters, column bed heights, and buffer conditions at each scale. Manufacturing-scale operation also achieved a 13% improvement in AAV recovery compared to bench-scale runs, highlighting the potential to enhance process efficiency while simplifying scale-up activities.
Key Results
- Demonstrated linear scalability from 1 L to 167 L load volumes
- Achieved a 13% increase in AAV recovery at manufacturing scale compared to bench scale
- Successfully scaled 100× from 5 mL to 515 mL OPUS® columns using the same process conditions
- Maintained consistent chromatography performance and product quality across scales
Download the Application Note to learn how Forge Biologics achieved predictable, reproducible AAV9 purification from process development through manufacturing using the KRM® 10 Chromatography System.
