Technoeconomic analysis of T7 RNA polymerase manufacturing in E.coli for South Africa
(2022) KETM05 20222Chemical Engineering (M.Sc.Eng.)
- Abstract
- 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... (More) - 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. (Less) - Popular Abstract
- The COVID pandemic revealed the African continent´s vulnerability in access to vaccines, when the COVID vaccine reached African countries later than other regions. In order to solve this problem WHO decided in 2021 to support African manufacturing by funding an mRNA vaccine technology transfer hub in South Africa. Ensuring sustainable mRNA vaccine manufacturing in South Africa, local access and profitable production of raw materials required for the vaccine are essential. The enzyme T7 RNA polymerase is one of the most expensive raw materials required for mRNA vaccine production. This is why it is of interest to investigate feasibility and profitability of South African manufacturing of T7 RNA polymerase.
Currently, the T7 RNA... (More) - The COVID pandemic revealed the African continent´s vulnerability in access to vaccines, when the COVID vaccine reached African countries later than other regions. In order to solve this problem WHO decided in 2021 to support African manufacturing by funding an mRNA vaccine technology transfer hub in South Africa. Ensuring sustainable mRNA vaccine manufacturing in South Africa, local access and profitable production of raw materials required for the vaccine are essential. The enzyme T7 RNA polymerase is one of the most expensive raw materials required for mRNA vaccine production. This is why it is of interest to investigate feasibility and profitability of South African manufacturing of T7 RNA polymerase.
Currently, the T7 RNA polymerase process can be found in open literature for lab-scale but not pilot or industrial scale. Neither can any indication of profitability for T7 RNA polymerase manufacturing be found. This study aimed to fill that gap by upscaling present lab-scale knowledge on T7 RNA polymerase production and model the process to investigate its economic feasibility in South Africa.
This project modelled the T7 RNA polymerase process using a simulation software. The results indicated that South African T7 RNA polymerase production is profitable and feasible. It was also shown that it is more affordable to manufacture T7 RNA polymerase in South Africa than purchase the enzyme from an international supplier.
In summary, this thesis work contributes to the understanding of how to produce an enzyme required for mRNA vaccine production and proved it is profitable for this raw material to be produced in South Africa. The results open for new research opportunities to enable an entire independent value chain for South African mRNA vaccine. This would contribute to establish vaccine access for the African continent, so to be well equipped for next pandemic as well as meeting current needs of other diseases. (Less)
Please use this url to cite or link to this publication:
http://lup.lub.lu.se/student-papers/record/9104112
- author
- Lundh, Alicia LU
- supervisor
- organization
- course
- KETM05 20222
- year
- 2022
- type
- H2 - Master's Degree (Two Years)
- subject
- keywords
- T7 RNA polymerase, enzyme manufacturing, mRNA vaccine manufacturing, chemical engineering
- language
- English
- id
- 9104112
- date added to LUP
- 2022-12-22 09:12:48
- date last changed
- 2022-12-22 09:12:48
@misc{9104112,
abstract = {{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.}},
author = {{Lundh, Alicia}},
language = {{eng}},
note = {{Student Paper}},
title = {{Technoeconomic analysis of T7 RNA polymerase manufacturing in E.coli for South Africa}},
year = {{2022}},
}