BioNTech has introduced its first modular mRNA manufacturing facility to improve vaccine supply in Ghana, Africa
It is the first mRNA manufacturing facility to become a node in a decentralised and robust African end-to-end manufacturing network.
The company presented the container solution named “BioNTainer” at a meeting at BioNTech’s new manufacturing facility in Marburg.
Attendees included:
- President Macky Sall of Senegal
- President Nana Akufo-Addo of Ghana
- President Paul Kagame of Rwanda,
- Director general of the World Health Organization Tedros Adhanom Ghebreyesus
- Director of the Africa Centers for Disease Control and Prevention (Africa CDC) John Nkengasong
- The federal minister of economic cooperation and development of Germany Svenja Schulze
Alongside BioNTech’s co-founders professor Ugur Sahin, CEO, professor Özlem Türeci, CMO, and COO Dr Sierk Poetting they discussed the infrastructure, regulatory and technological requirements to establish an end-to-end manufacturing network for mRNA-based vaccines in Africa.
The solution
The manufacturing solution consists of one drug substance and one formulation module which are known as a BioNTainer. Each module is built of six ISO sized containers (2.6m x 2.4m x 12m). Together, two modules require 800 sqm of space and offer an estimated initial capacity of 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 first of its kind
The first mRNA manufacturing facility is expected to be established in mid-2022 and the first BioNTainer is expected to arrive in Africa in the second half of 2022. Approximately 12 months after the delivery of the modules to its final location in Africa, manufacturing in the first BioNTainer can commence.
BioNTech expects to ship BioNTainers to Rwanda, Senegal and potentially South Africa in close coordination with the respective country and the African Union. The company will be responsible for the delivery and installation of the modules, while local organizations, authorities and governments will ensure the needed infrastructure. Partners in Ghana and South Africa could support the manufacturing with fill-and-finish capacities.
By working closely with local authorities, BioNTech will ensure compliance to relevant regulatory procedures of the national regulatory agencies in each partner country and coordinate where appropriate with relevant continental and international agencies, including WHO, Africa CDC, the African Medicines Agency (AMA), and the African Union Development Agency (AUDA-NEPAD).
BioNTech will initially staff and operate the facilities but eventually, the local partners will receive more independence. These vaccines will be made for domestic use and exported to other member states of the African Union at a not-for-profit price.
