Economic modelling of magnetic bead-based mAb manufacturing | Poster Board #285

Today's mAb market is highly innovative, driven by the competition of emerging biosimilars. Therefore, manufactures must become more efficient and streamlined to outcompete their competitors. Previously we have shown that magnetic bead-based processing can be beneficial for the manufacturing of mAbs. But understanding the impact of a new technology on a longer production stint is essential to draw conclusions under which conditions different DSP applications should be implemented.
In the presented study, we have modelled two yearlong manufacturing stints based on magnetic separation for the capture of antibodies. The model was fed with key findings from the experimental data and assumptions based on a database. The output was then subject to scrutiny with regards to COG/g and annual throughput. This results in a benchmarking of the two magnetic processes against the legacy manufacturing.
Both modelled processes show great improvements when benchmarked against the legacy process, reducing the COG of up to 38 % and the fixed investment of up to 17 %, while at the same time increasing the production throughput up to 40 %. More impressively, the magnetic based processes match the productivity reached by the USP, while the legacy process provides a productivity loss of around 150%.
In conclusion, the modelled magnetic based processes show significant improvements when benchmarked against today’s legacy process. Especially, when the USP dictates single high cell density harvest, the magnetic separation-based DSP provides a highly valuable option.