BioNTech has won approval from the European Medicines Agency (EMA) to manufacture its COVID-19 vaccine Marburg, Germany–based facility.
BioNTech will produce mRNA at the site, an instrumental component of the Comirnaty (BNT162b2) vaccine it jointly developed with Pfizer.
The manufacturing for the vaccine process requires approximately 50,000 steps, which spans mRNA synthesis and manufacture of the bulk drug substance, according to BioNTech.
With an annual production capacity of up to one billion doses of the COVID-19 vaccine annually, BioNTech expects the site to be one of the biggest mRNA vaccine manufacturing sites in Europe and the world. The site can produce a single batch of mRNA for approximately eight billion vaccine doses.
At present, 400 employees work at the site, which operates continuously.
BioNTech anticipates that it can produce up to 250 million doses of the vaccine in the plant in the first half of the year.