Construction of the first African messenger RNA (mRNA) manufacturing facility has started in Africa.
This means Biopharmaceutical New Technologies (BioNTech) SE is a step closer to producing mRNA vaccines that teach human cells how to make a protein that will trigger an immune response inside the body.
The company is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases.
It has just reached the next milestone in order to establish scalable mRNA vaccine production in Africa on its planned schedule.
Modular factories
BioNTech also welcomed its African partners for the first time to see the construction of the initial African mRNA manufacturing facility in Kigali, Rwanda. A target for the first set of manufacturing modular factories, dubbed BioNTainers is to be delivered to the site by the end of 2022.
Ugur Sahin, managing director and co-founder of BioNTech said: “This factory will be the first in an African network to provide sustainable production capacity for mRNA pharmaceuticals. Further manufacturing facilities in Africa and on other continents are planned to follow. The goal we pursue together with governments and regulatory authorities is to produce vaccines for Africa here with highly skilled professionals from Africa.”
The company expects to set up additional factories in Senegal and South Africa with its partners in the respective countries. All vaccines to be manufactured in the network will be dedicated to people residing in member states of the African Union.
BioNTech used the opportunity to give an update on the joint establishment of mRNA manufacturing facilities and the development plans for BioNTech’s malaria vaccine candidates.
Quality assurance
The company that co-developed the first approved mRNA-based vaccine (Pfizer-BioNTech COVID-19 vaccine), will work with staff from its sites in Germany to accelerate the training of about 100 colleagues who will be running the production and all associated laboratory and quality assurance tasks on site.
The Rwandan facility, with a size of about 30,000 square meters, will be initially equipped with two BioNTainers – one for the production of mRNA, and one for the production of the formulated bulk drug product.
The BioNTainers will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, which could conceivably include the Pfizer-BioNTech COVID-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved or authorized by regulatory authorities.
The estimated initial annual capacity of e. g. the Pfizer-BioNTech COVID-19 vaccine will be about 50 million doses. Manufacturing in the BioNTainers in Rwanda is expected to start approximately 12 to 18 months after they have been installed.
Vaccine resilience
Paul Kagame, President of the Republic of Rwanda said: “The groundbreaking work for BioNTech’s state-of-the-art mRNA production facility is a pivotal milestone. We are happy to have BioNTech as a partner, and I applaud the company’s commitment to working with Africa on a continental basis to help secure our vaccine resilience for the future, and invest in new research to address the endemic diseases that disproportionately affect our people. Working with our partners, Rwanda intends to build on this investment to attract a vibrant biopharmaceutical research and manufacturing sector.”
The company has a broad portfolio of oncology product candidates including individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules.
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