BioNTech said it has started production of Pfizer-BioNTech’s Covid-19 vaccine candidate at a new vaccine factory in Germany’s Marburg site, moving closer to its goal of boosting output in Europe by some 750 million doses a year.
The first batch produced at Marburg, north of Frankfurt, enough for 8 million doses, is scheduled for distribution in early April, BioNTech said in a statement.
“This new BioNTech site will become one of the largest mRNA manufacturing sites in Europe with an annual production capacity of up to 750 million doses of our COVID-19 vaccine, once fully operational,” the company said.
BioNTech plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021. The first vaccines manufactured at the Marburg site are scheduled for distribution in early April.
It takes only a few days to produce messenger RNA, the key ingredient in the vaccine developed by BioNTech with partner Pfizer Inc.
After initial production of the mRNA, it will be purified and concentrated. After completion of mRNA production, Lipid Nanoparticles (LNP) are formed by combining mRNA and a mixture of lipids. Following further purification, the newly created drug product will then be transported to a partner site for fill and finish under sterile conditions. In addition, a panel of quality tests will be performed to confirm the quality of the product prior to release.
The quality of the final product is analyzed by two independent laboratories: BioNTech’s quality control laboratory in Idar-Oberstein and the official medicinal batch laboratory (Paul-Ehrlich-Institute in Germany), the company said in a statement.
The product will also need to clear the European Medicines Agency’s quality controls before it can be shipped to customers.
The Marburg factory is a key piece of a plan by BioNTech and Pfizer to boost production of their shot to 2 billion doses this year.
Pressure is mounting on vaccine makers to produce more, in particular as the European Union moves more slowly on vaccinations than the U.S. or U.K.
BioNTech bought the Marburg site from Swiss pharma giant Novartis AG last year and plans to use it to supply the world outside the U.S. the plant is on track to produce as many as 250 million doses of Covid vaccine in the first half of this year, BioNTech said.
Meanwhile, a Pfizer factory in Puurs, Belgium, that had slowed production due to renovations is also back to full capacity.
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