BioNTech starts production at new COVID vaccine plant in Germany
Topics: BIONTECH GERMANY
"We started the manufacturing process at the Marburg facility with the execution of the first step: the production of mRNA, which is the active pharmaceutical ingredient of the Pfizer-BioNTech COVID-19 vaccine, the company says.
A single mRNA batch of the current scale is sufficient to produce around eight million vaccine doses. BioNTech plans to start the manufacturing of the drug substance based on the new manufacturing license granted from Darmstadt Regional Administrative Council for the amended facility in Marburg.
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).
To allow for supply of drug product from the site in Marburg, the production processes of the new facility need to be approved based on reviewing a range of quality and validation data by the European Medicines Agency (EMA).
Data from the first production batches including from process validation will be assessed via the centralized variation procedure coordinated by the EMA. This validation, as well as the submission of data and other required information, will take place in February and March.
Based on approval by the EMA, first drug product batches of the vaccine can then be delivered to partner sites for sterile fill and finish, before distribution to vaccination sites in line with established agreements with governments.
BioNTech’s manufacturing facility in Marburg is a GMP-certified manufacturing facility. Good manufacturing practice (GMP) is a system of regulatory standards for ensuring that products are consistently produced and controlled according to quality standards aiming for a high level of drug quality and patient safety.
The GMP regulations have been developed over decades to minimize the risks involved in any pharmaceutical production, including the vaccine production that cannot be eliminated through testing the final product. The production of vaccines under GMP standards are a prerequisite for the validation of the manufacturing processes by the EMA.
"With Pfizer, we are working continuously on multiple initiatives to respond to global demand. We have increased our manufacturing capacity to up to 2 billion doses of our COVID-19 vaccine for 2021, assuming continuous process improvements, expansion at current facilities and adding new suppliers and contract manufacturers, and the updated six-dose labeling," says BioNTech.
A key factor in the expansion of our manufacturing network has been the set-up of this new manufacturing site in Marburg, Germany.
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 their 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 manufactured at the Marburg site are scheduled for distribution in early April.
The vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the European Union, and the holder of emergency use authorizations or equivalent in the United States, United Kingdom, Canada and other countries in advance of a planned application for full marketing authorizations in these countries. ■