AAV manufacturing: The benefits of growing serum-free, suspension HEK293 cells in the scale-X™ fixed-bed bioreactor

Achieve 3-fold increase in AAV-2 cell-specific productivity using a suspension HEK293F cell line in the scale-X structured fixed-bed bioreactor

Adeno-associated viruses (AAVs) are a vector of choice for a wide range of therapeutic indications. Although early targets were for rare diseases, there is a shift towards higher prevalence indications such as cancers or common neurological disorders. This, combined with the high vector demand per dose sometimes exceeding 1015 vg, means that manufacturing capacity will increasingly become a bottleneck as the clinical pipeline matures. Industry has taken a stance to address this challenge by developing upstream platforms in suspension HEK293 cell lines in order to benefit from the large capacity offered by stirred tank bioreactors (STRs). However, intensifying and scaling-up STRs is complex, time-consuming can result is delays in the time to market.

Structured fixed-bed bioreactors offer an interesting alternative with a low-shear, well-controlled and homogeneous environment achieving high productivity, high product quality and cost-effectiveness in a reduced footprint for adherent and suspension cells. In this study, a 3-fold increase in cell-specific productivity with considerable decrease in volume and footprint, and substantial increase in volumetric cell concentration (up to 30-fold) compared to a suspension process are achieved using a suspension HEK293F cell line in the scale-X structured fixed-bed bioreactor, all while drastically reducing impurities in the harvest.

Interested? Download the article to read more about how to overcome capacity challenges in AAV manufacturing!

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