Scaling up an AAV production platform to support clinical and commercial needs: challenges and opportunities
Sponsor
Transient transfection of a suspension HEK293 bioreactor is becoming the preferred method of rAAV manufacturing. This is because of its versatility to produce a wide range of constructs that are more potent than other production strategies and can enable organizations to rapidly scale up manufacturing. With all its benefits, significant challenges face manufacturers to successfully scale up and execute large scale transient transfection. At Oxford Biomedica Solutions, we have solved these challenges by investing heavily into our platform and developing techniques that allow seamless production from 2L to 2000L scale using transient transfection. In this discussion, we will show data demonstrating that through understanding of the fundamental kinetics and optimization of transfection mixture, precise equipment engineering and the development of a robust purification process we can successfully execute large scale, straightforward transient transfection up to 2000L scale. Using our approach, we are now projecting to surpass greater than 1E17 total vgs from a single 500L. This level of productivity can help drug developers fully support clinical and commercial needs and open up the gene therapy space to address larger patient populations.Equipment engineering and process control are crucial for successful scale up of transient transfection
- Transition from ultracentrifugation to anion exchange chromatography and scaling up of anion exchange chromatography to achieve over 90% full capsids
- Comparability of titer, empty to full capsid ratio and product quality between 2 and 2000-L scale
- Rational design of satellite runs to support scale-up understanding
SPEAKERS
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