Research by the U.K.’s Centre for Process Innovation (CPI) has involved scaling up adeno-associated virus (AAV) manufacturing using suspension-based systems from flasks to 200-L bioreactors.
“The approach we’ve taken is not unique, but the data we’re generating is valuable because we have done a complete scale-up from start to finish,” explains Philip Probert, PhD, head of technical, biologics at the CPI.
Probert, who will be presenting the research at the World Smart Bioprocessing Pharma 4.0 summit next year, says he’s achieved an order-of-magnitude decrease in costs and increase in AAV titers compared to adherent-based techniques.
“With a viral-based process, small changes in yield can make big differences,” he says.
The pharmaceutical industry is accustomed to suspension-based techniques for biomanufacturing, he explains, but—until recently—it was difficult to produce good consistent titers of AAV.
Instead, the industry had turned to adherent culture systems, which needed large surface areas on which cells could grow. These, he explains, were hard to scale up to commercial quantities due to the low yields of virus and physical space needed.
Today, however, he says manufacturers are increasingly moving to suspension culture systems. Probert hopes his research, which uses human embryonic kidney (HEK) cells and largely standard industry techniques, will help to accelerate this trend.
The project is funded by the U.K. Research and Innovation (UKRI), a government body that directs research and innovation in funding. Probert believes being a grant-funded project will help him to widely disseminate his results.
“This work has been very well received, and we’re able to talk about it because of the nature of the funding,” he says. “Gene therapy is a relatively immature field, and so there’s lots of interest in discussing how to overcome challenges, and in what worked and didn’t.”
The project is due to close early next year, and he is looking for academic and commercial collaborators for future work.