BioNTech to Build Modular mRNA Manufacturing Facilities in Africa

BioNTech SE aims to improve vaccine supply in Africa by developing and delivering end-to-end mRNA manufacturing facilities based on a container solution. This modular-facility approach is designed to create scalable vaccine production that could become a decentralized manufacturing network.

The German biotech firm 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,” says Ursula von der Leyen, president of the European Commission. “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. 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.

The aforementioned container 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.