BioNTech starts production of mRNA for its COVID-19 vaccine in a new facility in Marburg, Germany. The former Novartis plant has been converted and now employs 300 people. A single batch at the current size is sufficient to produce 8 million vaccine doses, according to the company.
The new BioNTech site will become one of the largest mRNA production facilities in Europe with an annual production capacity of up to 750 million doses of the COVID-19 vaccine once fully operational. BioNTech plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021. The first vaccines produced at the Marburg site are expected to be shipped in early April.
mRNA is produced, purified, and concentrated. Lipid nanoparticles (LNP) are then formed by combining mRNA and a mixture of lipids. After further purification, the product is transported to a partner site for filling and finishing under sterile conditions. The quality of the final product is analyzed by two independent laboratories: BioNTech’s quality control laboratory in Idar-Oberstein, Germany, and the official medical batch laboratory, the Paul Ehrlich Institute, Langen, Germany.
To allow for supply of medicines from the Marburg site, the production processes of the new facility must be approved by the European Medicines Agency (EMA) based on the review of several quality and validation data. This will take place in February and March. Subsequently, the first drug batches of the vaccine can be delivered to the partner sites for sterile filling and finish.
- BioNTech, Mainz, Germany
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