BioNTech’s Marburg site was bought from Novartis last year to up COVID-19 vaccine supplies in Europe. The EMA has now approved the production of drug substance (the mRNA) at the site.
Once fully operational, the GMP-certified manufacturing site will have a production capacity of up to one billion doses of the Pfizer/BioNTech COVID-19 vaccine. The first doses are expected from the plant next month.
“A single mRNA batch of the current scale is sufficient to produce around eight million vaccine doses," explains BioNTech. "Currently, 400 BioNTech employees work in Marburg, 200 of them in 24/7 shifts in order to maximize the production’s output.
"Based on the approval by the EMA, first drug product batches of the vaccine can now be delivered to partner sites for sterile fill and finish, before distribution to the European Union and countries worldwide. The first batches of vaccines manufactured at the Marburg site are expected to be delivered in the second half of April.
“In total, 50,000 steps are required from manufacturing the mRNA to the bulk drug substance which then can be handed over for fill and finish. Materials and components for production arrive from a global supply chain that has been dramatically expanded in the last 12 months.”
Pfizer and BioNTech now have three active substance manufacturing sites in the EU included in their COVID-19 vaccine conditional marketing authorisation.
AstraZeneca and Moderna
A new manufacturing site in The Netherlands has been approved for the production of AstraZeneca’s COVID-19 vaccine active substance. The Halix site will bring the total number of manufacturing sites licensed for the production of the active substance in the EU to four.
The EMA’s CHMP (human medicines committee) has also recommended approving new manufacturing lines for Moderna’s mRNA vaccine at Lonza’s Visp, Switzerland facility.