BioNTech says it has taken a next step to improve vaccine supply in Africa by introducing an approach to establishing scalable vaccine production that develops and delivers turnkey mRNA manufacturing facilities based on a container solution called “BioNTainer.”
The method consists of 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 advanced manufacturing solutions, according to the company. Together, two modules require 800 square meters 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 (e.g., 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 capacity can be scaled up by adding further modules and sites to the manufacturing network on the African continent. 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, explained a company official.
The establishment of the first mRNA manufacturing facility by BioNTech in the African Union is expected to start in mid-2022. The first BioNTainer is expected to arrive in Africa in the second half of 2022. Manufacturing in the first BioNTainer is planned to commence approximately 12 months after the delivery of the modules to its final location in Africa.
BioNTech expects to ship BioNTainers to Rwanda, Senegal, and potentially South Africa in coordination with the respective country and the African Union. BioNTech will be responsible for the delivery and installation of the modules, while local organizations, authorities, and governments are expected to provide the needed infrastructure. Partners in Ghana and South Africa could support the manufacturing with fill-and-finish capacities.
BioNTech officials say they will work closely with local authorities to ensure compliance to relevant regulatory procedures of the national regulatory agencies in each partner country, and also 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 notes that it will initially staff and operate the facilities to support the safe and rapid initiation of the production of mRNA-based vaccine doses under good manufacturing processes (GMP) 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.
“Today’s milestone brings us one step closer to our goal of improving healthcare by making our innovations accessible worldwide,” said Ugur Sahin, MD, CEO and co-founder of BioNTech.
“We have initiated the BioNTainer project in January 2021 after knowing that we had an approved mRNA-based vaccine,” added Sierk Poetting, PhD, COO of the company. “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 decentralized 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.”