Cost evaluation of antibody production processes in different operation modes

Abstract An increasing market pressure through biosimilars and other factors lead to the necessity of economic process mode evaluations of antibody production processes. This work compares a fed-batch and a continuously operated platform process based on a cost of goods (CoG) calculation. For a production capacity of 200 kgAPI/a the comparison reveals great differences between the upstream and downstream CoG of both process modes. Whereas the fed-batch process has total specific CoG of 59 €/gmAb, the continuously operated process results in 84 €/gmAb, which is mainly caused by the expensive upstream part. Due to a high consumption of perfusion fermentation medium, the continuously operated upstream is about 33 €/gmAb more expensive compared to the fed-batch upstream. Contrary to the upstream part, the continuously operated downstream is about 8 €/gmAb cheaper than the downstream of the batch process. This difference is mainly caused by a better utilization of chromatography resins in the continuously operated downstream. As a result of this comparison, a third process mode is evaluated: the hybrid process. The hybrid process combines the beneficial parts of both process modes, i.e. a fed-batch upstream is combined with a continuously operated downstream. Compared to the fed-batch process, the hybrid process results in total specific CoG of 50 €/gmAb for a production capacity of 200 kgAPI/a, which corresponds with a reduction in CoG by 15%. Variation of the production capacity from 50 to 1000 kgAPI/a confirms the superiority of the hybrid process compared to the two alternative process modes.

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