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The turnkey facilities will promote scalable vaccine production for an end-to-end manufacturing network for mRNA-based vaccines in Africa.
BioNTech SE aims to improve vaccine supply in Africa by developing and delivering turnkey messenger RNA (mRNA) manufacturing facilities based on a container solution, the company said in a Feb. 16, 2022 press release. This modular-facility approach is designed to create scalable vaccine production that could become a decentralized manufacturing network.
BioNTech presented the container solution named “BioNTainer” at a meeting attended by key partners including the presidents of Ghana, Rwanda, and Senegal; the director-general of the World Health Organization; the director of the Africa Centers for Disease Control and Prevention; and the Federal Minister of Economic Cooperation and Development of Germany.
The group discussed the infrastructure, regulatory, and technological requirements needed to establish an end-to-end manufacturing network for mRNA-based vaccines in Africa.
“mRNA vaccines made in Africa, for Africa, with world-class technology. This initiative is a real trailblazer in our global fight against the pandemic,” said Ursula von der Leyen, president of the European Commission, in the press release. “By pooling forces, the European Union and the African Union can achieve so much more, for mutual benefit. Team Europe has committed one billion Euros. And the EU will support Africa’s ambition to build up vaccine manufacturing and regulatory capacities.”
Each BioNTainer cleanroom module is built of six ISO-sized containers (2.6m x 2.4m x 12m). A drug substance module and a formulation module are used to produce mRNA vaccine in bulk, and fill/finish of the bulk vaccine is done by local partners. Two modules offer an estimated initial capacity of, for example, up to 50 million doses of the Pfizer-BioNTech COVID-19 vaccine each year, according to the press release. Capacity can be scaled up by adding further modules and sites to the manufacturing network.
The first BioNTainer is expected to arrive in Africa in the second half of 2022, and production is planned to begin approximately 12 months after the delivery of the modules. BioNTech expects to ship BioNTainers to Rwanda, Senegal, and potentially South Africa. BioNTech will be responsible for the delivery and installation of the modules, and local organizations will provide infrastructure. BioNTech will initially staff and operate the facilities and then will transfer know-how to local partners to enable independent operation. BioNTech will partner with local quality control testing labs for tests for each finished vaccine batch. Vaccines manufactured in these facilities are expected to be dedicated to domestic use and export to other member states of the African Union at a not-for-profit price.
“The modular production facilities are a big step in our journey to enable the production of high-quality mRNA vaccine manufacturing worldwide, with each BioNTainer becoming a node in a decentralized and robust African end-to-end manufacturing network,” said Sierk Poetting, COO of BioNTech, in the press release. “The modular and scalable approach could allow us to set-up turnkey manufacturing sites for mRNA on all continents. Once rolled out, the approach could support clinical trials as well as regional pandemic preparedness measures.”
The BioNTainer will be equipped to manufacture a range of mRNA-based vaccines, such as the Pfizer-BioNTech COVID-19 vaccine. It could also be used to manufacture BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved, or authorized by regulatory authorities.