Technoeconomic analysis of T7 RNA polymerase manufacturing in E.coli for South Africa

Sammanfattning: The enzyme, T7 RNA polymerase (T7 RNAP), is one of the most expensive raw materials required for mRNA vaccine production. As part of establishing South African manufacturing of mRNA vaccine, it is of interest to investigate the feasibility and profitability of South African manufacturing of T7 RNAP. This project scaled up present lab-scale knowledge on T7 RNAP production and used SuperPro designer as a tool to model a T7 RNAP process. In order to achieve South African annual demand of the enzyme required in mRNA vaccine manufacturing, the model suggested a main bioreactor size of 15L and operating approximately 1.5 months a year. The economic assessment for the base case model, concluded the NPV to be $19,250,000, IRR to be 21.33% with a 3.92 years payback time. The results also imply that it is more affordable to manufacture T7 RNA polymerase in South Africa than purchase the enzyme from an international supplier. The sensitivity analysis showed that the model was sensitive to changes in revenue. If T7 RNAP can be sold for approximately $2 million per gram, instead of $136 000 as the base case, higher profitability such as IRR of 148% and 0.23 years payback time can be expected. The model was also sensitive to changes in process parameters of both biomass yield and T7 RNAP yield. The evaluation of result validity suggests more research needs to be performed to obtain accurate and modern yields for industrial scale. Overall, the results indicate that South African T7 RNAP production is profitable and has capacity for more production annually than demanded in South Africa. Thus, it is recommended to investigate the possibilities to manufacture other required enzymes for mRNA vaccine production with the same process, to enable an independent value chain for South Africa.