Germany-based biotechnology company BioNTech opened its first modular messenger ribonucleic acid (mRNA) vaccine manufacturing facility in Kigali, Rwanda, to promote sustainable vaccine production and end-to-end vaccine supply in African Union (AU) member states.
The facility manufactures mRNA vaccines as part of the company’s malaria and tuberculosis vaccine development programmes. It serves as a confluence point in a decentralised, robust network of end-to-end manufacturing in Africa.
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BioNTech invested approximately $150m (€127.13m) in the facility. The groundbreaking ceremony for the facility was held in June 2022, which occurred after the EU and the Rwanda Food and Drugs Authority signed a Twinning agreement to enhance Rwanda’s regulatory environment for medical items and vaccines.
BioNTech inaugurated its Kigali site in December 2023. The facility is currently undergoing further development to establish full end-to-end manufacturing capabilities.
In May 2024, the Coalition for Epidemic Preparedness Innovations committed $145m to support BioNTech to establish mRNA vaccine research and development, clinical and commercial-scale manufacturing capabilities at the Kigali manufacturing site.
In October 2025, the European Commission (EC) and the European Investment Bank awarded blended financing of up to €95m to help advance the Kigali facility to produce mRNA vaccines for diseases such as malaria, tuberculosis, HIV and mpox.
BioNTech’s mRNA vaccine facility development
In August 2021, BioNTech agreed to set up vaccine production capabilities in Africa together with the kENUP Foundation, President Paul Kagame of Rwanda, President Macky Sall of Senegal and President Ursula von der Leyen of the EC.
The decision was guided by the AU, the Africa Centres for Disease Control and Prevention and the African Medical Agency under formation.
In addition to its Kigali facility, BioNTech plans to establish factories in Senegal and South Africa with its partners in the two countries.
The company worked closely with local authorities to ensure compliance with the relevant procedures of the national regulatory agencies in each partner country.
It also coordinated with relevant continental and international agencies including the World Health Organization, the Africa Centres for Disease Control and Prevention, the African Medicines Agency and the African Union Development Agency in developing the Kigali facility.
BioNTech mRNA vaccine manufacturing facility details
The BioNTech vaccine manufacturing facility spans 35,000m² and features two BioNTainers, one for manufacturing mRNA and the other for producing the formulated bulk drug product.
The manufacturing of BioNTainers and the procurement of process equipment were coordinated at BioNTech’s innovation centre in Marburg, while the development of the production hall and any associated infrastructure took place in Rwanda.
The fully self-sufficient BioNTainers, spanning a space of 800m², are capable of manufacturing a range of mRNA-based vaccines based on the requirements of AU member states.
A container-based plug-and-play approach with modular design, standardised equipment and software components supports the rapid set-up of a fully functional mRNA manufacturing facility at the site.
The Kigali plant also features power and water supply infrastructure, quality control labs, quality assurance set-up, warehousing, and cold and frozen storage.
The facility’s initial production capacity is expected to be approximately 50 million doses a year. After validation, the Kigali facility will become a model project, guiding the establishment of mRNA-based vaccine manufacturing facilities of varying sizes to meet local or regional demands for clinical trials or commercial production.
BioNTainers design and features
The BioNTainers form scalable mRNA manufacturing facilities based on a container solution for single to multidrug production and clinical trials. The BioNTainer is a cleanroom equipped with state-of-the-art manufacturing solutions.
BioNTech’s vaccine manufacturing facility comprises a drug substance module and a drug product (DP module) formulation module, each called a BioNTainer. Each module comprises six ISO-sized containers measuring 2.6m × 2.4m × 12m, enabling the bulk production of mRNA vaccines.
The DS module is equipped with a bioreactor for mRNA production.
The purification and concentration of the produced mRNA also take place in the same module, while the drug product formulation is carried out in the facility’s DP module. In addition, filling and packaging support is provided by BioNTech’s local partners.
