The Rwandan facility, which will be around 30,000 square meters in size, will be initially equipped with two ‘BioNTainer’ modules: one for the production of mRNA, and one for the production of the formulated bulk drug product.
The BioNTainers will be equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states, which could include the Pfizer-BioNTech COVID-19 vaccine and BioNTech’s investigational malaria and tuberculosis vaccines, if they are successfully developed, approved or authorized by regulatory authorities.
The estimated initial annual capacity of the site will be around 50 million doses (based on the Pfizer-BioNTech COVID-19 vaccine).
The first set of BioTainers are set to be delivered to the site by the end of 2022: with manufacturing expected to follow approximately 12 to 18 months after their installation.
The facility will employ around 100 staff by 2024.
As BioNTech works to create a ‘decentralized and robust African end-to-end manufacturing network’, additional sites in Senegal and South Africa are set to follow.
The German mRNA specialist's modular manufacturing concept is based on one drug substance and one formulation module: each called a BioNTainer. Each module is built of six ISO sized containers (2.6m x 2.4m x 12m). This allows for mRNA vaccine production in bulk (mRNA manufacturing and formulation), while fill-and-finish will be taken over by local partners.
Each BioNTainer is a clean room which BioNTech equips with manufacturing solutions. Together, two modules require 800 sqm 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.
Capacity can be scaled up by adding further modules and sites to the manufacturing network on the African continent.