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

Findings open way for personalised MS treatment

Currently available therapies to treat multiple sclerosis (MS) lack precision and can lead to serious side effects. Researchers at Karolinska Institutet in Sweden have no...

Pfizer shares top-line results from Phase 2/3 EPIC…

Pfizer Inc. (NYSE: PFE) shared top-line results from the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study evaluating...

Pfizer and Biohaven's VYDURA® (rimegepant) granted…

Pfizer Inc. (NYSE: PFE) and Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced that the European Commission (EC) has granted marketing authorizatio...

A smarter way to develop new drugs

Pharmaceutical companies are using artificial intelligence to streamline the process of discovering new medicines. Machine-learning models can propose new molecules that ...

Foundation S: Sanofi's new philanthropic spearhead

Sanofi today launches Foundation S - The Sanofi Collective, its philanthropic endowment fund aiming to create healthier futures for generations. Using donations, partners...

Cognitive impairment from severe COVID-19 equivale…

Cognitive impairment as a result of severe COVID-19 is similar to that sustained between 50 and 70 years of age and is the equivalent to losing 10 IQ points, say a team o...

SK bioscience and GSK's adjuvanted COVID-19 vaccin…

SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s...

Investigational COVID mucosal vaccine protects aga…

In animal studies that mimic human exposures, an investigational COVID vaccine designed to be taken orally not only protects the host, but also decreases the airborne spr...

Using AI to analyze large amounts of biological da…

Researchers at the University of Missouri are applying a form of artificial intelligence (AI) - previously used to analyze how National Basketball Association (NBA) playe...

Asthma drug can block crucial SARS-CoV-2 protein

A drug used to treat asthma and allergies can bind to and block a crucial protein produced by the virus SARS-CoV-2, and reduce viral replication in human immune cells, ac...

Recurring brain tumor growth is halted with new dr…

When a non-metastatic brain tumor - a meningioma - recurs after surgery and radiation treatment, a patient is out of options. No drugs are approved for these aggressive t...

Pfizer to acquire Biohaven Pharmaceuticals

Pfizer Inc. (NYSE: PFE) and Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) have entered into a definitive agreement under which Pfizer will acquire Biohaven, t...