German pharmaceutical firm, BioNTech on Wednesday, February 16 introduced the first modular mRNA manufacturing facility to promote scalable vaccine production in Africa at a high-level meeting held in Marburg, Germany with world leaders including President Paul Kagame present. This follows the signing of a Memorandum of Understanding between Rwanda, Senegal and BioNTech to initiate the construction of the state-of-the-art manufacturing plant for mRNA-based vaccines slated for mid-2022. The firm aims to accelerate the building of a Good Manufacturing Practice (GMP)-certified manufacturing facility and plan to begin the establishment in mid-2022. Below, we have compiled five things that you should know about the process that will see Rwanda producing vital vaccines for Rwandans and the continent at large. 1. Use of containers BioNTech introduced its approach to establishing vaccine production plants by developing and delivering manufacturing facilities based on a container solution. The model was presented at the meeting at BioNTech’s new manufacturing facility in Marburg. The container solution is dubbed “BioNTainer” and it is expected to reduce the time that would have otherwise been spent building a manufacturing plant and ensuring conformity to standards. According to an information pack by BioNTech, the manufacturing solution consists of one drug substance and one formulation module, each called a BioNTainer. Each module is built of six sized containers (2.6m x 2.4m x 12m). This allows for vaccine production in bulk (mRNA manufacturing and formulation), while bottling and packaging will be taken over by local partners. Each container is a clean room which BioNTech equips with manufacturing solutions. Initial estimates show that two modules will sit on about 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 annually. The container will come equipped to manufacture a range of mRNA-based vaccines targeted to the needs of the African Union member states with initial suggestion noting that it could include Pfizer-BioNTech’s Covid-19 vaccine and BioNTech’s malaria and tuberculosis vaccines, which are still under development and subject to authorization by regulatory authorities. 2. Scalability The firm in a statement said that the capacity can be scaled up by adding further modules and sites to the manufacturing network. This will allow for expansion depending on demand. The Rwandan production is line expected to initially produce 50 million doses, with the potential to later increase. 3. Quality control One of the most critical parts of the manufacturing process is quality control, which includes all necessary tests for each finished vaccine batch. In partnership with local quality control testing labs, BioNTech will help to ensure the identity, composition, strength, purity, absence of product- and process-related impurities, as well as the absence of microbiological contamination of each produced batch. 4. Timelines The establishment of the first mRNA manufacturing facility by BioNTech is expected to start in mid-2022 with the first container expected to arrive in Africa in the second half of 2022. Manufacturing in the first container is planned to commence approximately 12 months after the delivery of the modules to its final location. BioNTech say that they expect to ship containers to Rwanda, Senegal and potentially South Africa in close coordination with the respective country and the African Union. The firm will be responsible for the delivery and installation of the modules, Rwanda will ensure the needed infrastructure is available. It will work closely with local authorities to ensure compliance to relevant regulatory procedures of the national regulatory agencies such as the Food and Drug Authority and also coordinate where appropriate with relevant continental and international agencies, such as World Health Organization, Africa CDC, the African Medicines Agency (AMA), and the African Union Development Agency (AUDA-NEPAD). 5. Capacity Building According to a statement by the firm, BioNTech will initially staff and operate the facilities to support the safe and rapid initiation of the production of mRNA-based vaccine doses under stringent good manufacturing processes to prepare for the transfer of know-how to local partners to enable independent operation. Vaccines manufactured in these facilities are expected to be dedicated to domestic use and export to other member states of the African Union at a not-for-profit price.
