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BioNTech SE has introduced its approach to establishing scalable vaccine production in Africa by developing and delivering turnkey mRNA manufacturing facilities based on a container solution

220214 BioNTainer 004Each module is built of six ISO sized containers which allows for mRNA vaccine production in bulk. (Image source: BioNTech)

The manufacturing solution consists of one drug substance and one formulation module, each called a ‘BioNTainer’. Each module is built of six ISO sized containers which allows for mRNA vaccine production in bulk. Each BioNTainer is a clean room which BioNTech equips with state-of-the-art manufacturing solutions. Together, two modules require 800 sq m of space and offer an estimated initial capacity of for example up to 50 million doses of the Pfizer-BioNTech Covid-19 vaccine each year. 

The BioNTainer will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, for example the Pfizer-BioNTech Covid-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines.

The solution was revealed at a meeting at facility in Marburg with high-level attendees including President Macky Sall of Senegal; President Nana Akufo-Addo of Ghana; President Paul Kagame of Rwanda; Tedros Adhanom Ghebreyesus, director general of the World Health Organization; John Nkengasong, director of the Africa Centers for Disease Control and Prevention; and Svenja Schulze, the federal minister of economic cooperation and development of Germany. 

The establishment of the first mRNA manufacturing facility by BioNTech in the African Union is expected to start in mid-2022. The first BioNTainer is expected to arrive in Africa in the second half of 2022. Manufacturing in the first BioNTainer is planned to commence approximately 12 months after the delivery of the modules to its final location in Africa. 

BioNTech expects to ship BioNTainers to Rwanda, Senegal and potentially South Africa in close coordination with the respective country and the African Union. BioNTech 

Ursula von der Leyen, president of the European Commission, commented, “mRNA vaccines made in Africa, for Africa, with world-class technology. This initiative is a real trailblazer in our global fight against the pandemic. 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.”