BioNTech has lifted the curtain on its mRNA manufacturing strategy in Africa.
The company’s plan hinges on modular factories housed in shipping containers kitted out to make its COVID-19 vaccine from start to finish, apart from the last fill-finish step.
Over the past two years, BioNTech has figured out the trick to large-scale manufacturing of its Pfizer-partnered COVID-19 vaccine from its mRNA production plant in Marburg, Germany.
“On the other hand, we also learned how to run these processes and miniaturize them and make them into modular units,” chief operating officer Sierk Poetting said on a conference call Wednesday.
Enter the company’s Africa-bound modular factories, dubbed BioNTainers, which consist of one drug substance and one formulation module, for a total footprint of about 800 square meters. Each module is built from six standard shipping containers.
Leveraging this approach, BioNTech figures mRNA manufacturing and formulation can be done in bulk, while the fill and finish step will be left to local partners. Each complete BioNTainer setup, comprising twelve total shipping containers, will have capacity to crank out some 50 million doses a year, the company added.
The company isn’t limiting its container plants to COVID-19, either.
“COVID-19 might not be relevant in 5, 6, 7 years, but the manufacturing technology will be relevant,” BioNTech CEO Ugur Sahin said on the company’s call. That’s because “we know that mRNA is a new drug class, which is suitable for different types of vaccines,” the CEO said.
RELATED: BioNTech to start building mRNA vaccine manufacturing plant in Africa in mid-2022
BioNTech is already planning to use its BioNTainers to produce its experimental tuberculosis, HIV and malaria vaccines in Africa, should they be approved. The company has also pledged to bring its investigational cancer immunotherapies to the continent, Sahin said.
The mRNA specialist expects to set up its modular factories in Senegal, Rwanda and potentially South Africa. The company on Wednesday also unveiled a new project in Ghana to supplement fill-finish capabilities.
BioNTech plans to start setting up its first BioNTainer in Africa in the middle of the year. BioNTainer manufacturing is poised to kick off roughly 12 months after the delivery of the module to its first location in Africa.
For the future, scaling up capacity would be as simple as adding further modules, BioNTech explained. BioNTech isn’t yet commenting on the price of its BioNTainers, but the modular approach should prove “way cheaper” than a traditional factory buildout, COO Poetting explained.
BioNTech will staff and operate the facilities to start. It will likely take about 2 to 3 years for the BioNTainers to run independent of BioNTech, Poetting added. Once processes and know-how are transferred over, BioNTech needs to weigh the business model of how to hand over a facility, the COO said.
Vaccines made in the BioNTainers are expected to be used domestically and exported to other African Union member states at a not-for-profit price.
RELATED: Pfizer stalls COVID-19 vaccine app as it awaits data on 3rd dose in young kids
BioNTech’s BioNTainer reveal comes right after medical journal The BMJ accused The kENUP Foundation–a public benefit foundation representing BioNTech–of undermining a World Health Organization push to help African companies manufacture COVID-19 vaccines.
WHO’s South African-based technology transfer hub, which launched in June, uses publicly-available information to recreate Moderna’s COVID-19 vaccine, with the eventual goal to develop a comparable vaccine for production on the continent. But kENUP Foundation says the hub should halt the project, citing concerns about potential patent violations, The BMJ reported last week.
Still, there’s room in Africa’s burgeoning mRNA scene for both BioNTech and local manufacturers, according to the director-general of the World Health Organization.
“We welcome BioNTech’s initiative to increase vaccine production in Africa, as a complement to WHO’s mRNA technology transfer hub in South Africa and its network of ‘spokes’ around the world,” WHO’s Tedros Adhanom Ghebreyesus said in a statement.
