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 member states.
The facility will manufacture mRNA vaccines as part of the company’s malaria and tuberculosis vaccine development programmes. It will serve as a confluence point in a decentralised, robust network of end-to-end manufacturing in Africa.
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BioNTech has invested approximately $150m in the facility. The ground-breaking ceremony for the facility was held in June 2022, which occurred after the European Union and 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, which includes the company’s first high-tech, digitally enabled modular manufacturing units called BioNTainers. The clinical trials for various vaccine candidates are planned for 2024.
The company expects that, after providing specialised personnel with local training in 2024, it will be able to commence manufacturing batches of mRNA-based vaccines necessary for process validation in 2025.
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 European Commission.
The decision was guided by the African Union, 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 new 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 are coordinated at BioNTech’s innovation centre in Marburg while the development of the production hall and any associated infrastructure take place in Rwanda.
The fully self-sufficient BioNTainers are capable of manufacturing a range of mRNA-based vaccines based on the requirements of African Union member states, possibly including the Pfizer-BioNTech Covid-19 vaccine and BioNTech’s investigational vaccine candidates for malaria and tuberculosis, if developed and approved by regulatory authorities.
A container-based plug-and-play approach with modular design, standardised equipment, and software components support 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 x 2.4m x 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 are provided by BioNTech’s local partners.
The two modules span a space of 800m² and offer an estimated initial production capacity of up to 50 million doses a year.
