BioNTech develops modular mRNA manufacturing facilities for Africa

BIONTECH has announced that it is introducing modular and scalable mRNA manufacturing facilities in several countries in Africa.

The company is establishing scalable vaccine production using modular manufacturing facilities based on container units. Each manufacturing module is known as a BioNTainer and consists of six containers. Each facility will have two modules; the first will have a bioreactor for mRNA production and will be capable of mRNA purification and concentration; the second will be used for drug product formulation. Fill-and-finish will then be performed by local partners. The two modules will have a capacity of up to 50m doses of the Pfizer-BioNTech Covid-19 vaccine each year. Capacity can then be scaled up by adding more modules and expanding to additional sites.

It expects to ship BioNTainers to Rwanda, Senegal and potentially South Africa, with the first expected to arrive in the second half of 2022 and manufacturing expected to begin a year later. Local partners in Ghana and South Africa will support the fill-and-finish phase.

BioNTech will operate the facilities initially to ensure safe and rapid initiation of production under good manufacturing practice (GMP), while preparing for the transfer of knowledge to local employees to enable independent operation. Vaccines manufactured at these facilities will be used for domestic use or exported to other African countries at not-for-profit rates.

The BioNTainers can also be used to produce other mRNA-based vaccines specific to the region’s needs, such as BioNTech’s malaria and tuberculosis vaccines which are currently at pre-clinical stages in development.

Paul Kagame, President of the Republic of Rwanda, said: “BioNTech’s innovative modular production system opens up a new horizon for global vaccine equity. Rwanda looks forward to initiating mRNA vaccine manufacturing in the near future, in collaboration with BioNTech and our partners in Africa, Europe, and beyond.”

Sierk Poetting, COO of BioNTech, said: “We have initiated the BioNTainer project in January 2021 after knowing that we had an approved mRNA-based vaccine. 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 decentralised and robust African end-to-end manufacturing network. 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.”