BioNTech provides update on vaccine production status at Marburg manufacturing site

BioNTechBioNTech SE today announced that the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. As part of the process, EMA has approved the production of the drug substance, the mRNA, at the Marburg site over the course of this week. The approvals make BioNTech's Marburg manufacturing site one of the largest mRNA vaccine manufacturing sites in Europe as well as worldwide with an annual production capacity of up to one billion doses of the COVID-19 vaccine, once fully operational. Due to optimized operational efficiencies which were initiated last year, BioNTech has been able to increase the expected annual manufacturing capacity by 250 million doses.

A single mRNA batch of the current scale is sufficient to produce around eight million vaccine doses. 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.

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.

Together with our partner Pfizer, we are working continuously on multiple initiatives to respond to global demand. A key factor in the expansion of our manufacturing network has been the set-up of this new manufacturing site in Marburg, Germany. BioNTech plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021.

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.

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

Most Popular Now

Positive new data for Johnson & Johnson single…

Johnson & Johnson (NYSE: JNJ) (the Company) announced data that demonstrated its single-shot COVID-19 vaccine generated strong, persistent activity against the rapidly sp...

GSK and Alector announce global collaboration in i…

GlaxoSmithKline plc (LSE/NYSE: GSK) and Alector (Nasdaq: ALEC), today announced a strategic global collaboration for the development and commercialisation of two clinical...

Tezepelumab granted Priority Review by U.S. FDA

Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelu...

One shot of the Sputnik V vaccine triggers strong …

A single dose of the Sputnik V vaccine may elicit significant antibody responses against SARS-CoV-2, finds a study published July 13 in the journal Cell Reports Medicine...

Are silver nanoparticles a silver bullet against m…

Antimicrobials are used to kill or slow the growth of bacteria, viruses and other microorganisms. They can be in the form of antibiotics, used to treat bodily infections...

"Long COVID": More than a quarter of COV…

In a new study of adults from the general population who were infected with COVID-19 in 2020, more than a quarter report not having fully recovered after six to eight mon...

mRNA vaccines slash risk of COVID-19 infection by …

People who receive mRNA COVID-19 vaccines are up to 91 percent less likely to develop the disease than those who are unvaccinated, according to a new nationwide study of ...

Cancer cells eat themselves to survive

It is the membrane of cancer cells that is at the focus of the new research now showing a completely new way in which cancer cells can repair the damage that can otherwis...

U.S. FDA grants Priority Review for the Biologics …

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that the U.S. Food and Drug Administration (FDA) granted Priority Review designation for the Biologics Li...

Collaboration between AbbVie, Biogen and Pfizer cr…

The access to the world's largest browsable resource linking rare protein-coding genetic variants to human health and disease was launched through a genetic exome sequenc...

Artificial intelligence could be new blueprint for…

Writing in the July 12, 2021 online issue of Nature Communications, researchers at University of California San Diego School of Medicine describe a new approach that uses...

Anti-tumor agent from the intestine

It is believed to be involved in the development of chronic inflammatory intestinal diseases, to trigger diabetes, to be responsible for obesity, even neurological diseas...