GMP Certified mRNA Manufacturing Site, BioNTech, Marburg, Germany

Next-gen immunotherapy company BioNTech announced this month the completion of a share purchase agreement with Swiss pharma giant Novartis AG, to acquire their GMP certified manufacturing site located in Marburg, Germany.

Set to become the largest mRNA manufacturing site in Europe

The facility is expected to become one of the largest mRNA manufacturing sites in Europe. Once the new GMP manufacturing facility is fully operational, it will be able to expand BioNTech’s COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month.

Production capacity of 750 million doses of the potential mRNA COVID-19 vaccine per year

The company anticipates for the transaction to close in Q4 of 2020. Through this project, BioNTech plans to be able to manufacture up to 250 million doses of its mRNA COVID-19 vaccine candidate BNT162b2 in the first half of 2021. Thanks to the already established team and proven drug substance and drug product production capabilities at the site, the plant is expected to become the third site in the BioNTech manufacturing network in Germany to produce BNT162 for global supply.

Equipped with state-of-the-art mRNA production technology and with an established workforce

The Marburg mRNA production site is a state-of-the-art, multi-platform GMP certified manufacturing facility that is currently employing around 300 workers. BioNTech is set to take over the entire site along with all of its current 300 employees, enabling a rapid transition to BNT162 production once the transaction closes.

The plant is fully equipped with the latest technology for the production of recombinant proteins as well as cell and gene therapies, and holds cell culture labs and viral vector production capabilities, with further potential for long-term growth and expansion.

Dr. Sierk Poetting, Chief Financial Officer and Chief Operating Officer at BioNTech explained:

“This acquisition reflects BioNTech’s commitment to significantly expanding its manufacturing capacity in order to supply a potential vaccine worldwide upon authorisation or approval. We are working closely with Novartis to prepare for a smooth transition, and we look forward to welcoming the new members of our team and tapping into their impressive skills and expertise. From a strategic standpoint, the new site will bolster our vertically integrated business model with in-house manufacturing capabilities for mRNA manufacturing as well as vaccine formulation.”

The Marburg site has a 100-year long history of innovation: the manufacturing site, named Behringwerke, was established in 1904 by Emil von Behring, who developed the antitoxin for Diphtheria and Tetanus. He used the award money he received with the Nobel Prize in Medicine in 1901 to finance the manufacturing site. Since its founding in 1904, the Behringwerke has been at the forefront of pharmaceutical and biologic innovation, including the production of vaccines, resulting in a highly established infrastructure.

The strategic location of the GMP certified site

Large investments have been flowing into the modern site over the last five years by Novartis, which is located in a life science industry park that is home to more than 10 companies with 6,000 employees in total, and also provides an excellent infrastructure for the Company. The location is also particularly convenient as the industrial park is located within one hour drive from Frankfurt Airport and within 90 minutes from BioNTech’s headquarters in Mainz, Germany.

The BNT162 COVID-19 vaccine program

The project is planned to speed-up BioNTech’s efforts of scaling up its commercial manufacturing capacity to produce its mRNA COVID-19 vaccine candidate BNT162. The BNT162 program includes 5 mRNA vaccine candidates currently in clinical testing in the United States, Europe, South America, and China. BioNTech and Pfizer are evaluating the lead candidate, BNT162b2, in a global Phase III trial.

The modern facility is expected to operate as one of the largest mRNA manufacturing sites in Europe alongside two of BioNTech’s existing GMP facilities which currently produce the COVID-19 vaccine candidates for clinical trials, and in addition to at least four Pfizer production sites in the United States and Europe. The Marburg facility is expected to start the production of mRNA and the LNP formulation for a COVID-19 vaccine in the first half of 2021, pending regulatory authorisation or approval. BioNTech aims to produce additional therapeutic and vaccine drug candidates at the plant, such as other mRNA vaccines, antibody, and cell and gene therapy product candidates to underpin the development of its diversified cancer and infectious disease product pipeline. In addition, BioNTech plans to use the Marburg facility to contribute to the production of the COVID-19 vaccine for global supply, including to China, where it is partnered with Fosun Pharma, subject to regulatory authorization or approval.

BioNTech and Novartis anticipate completing the transaction in the fourth quarter of 2020, subject to regulatory approval and the satisfaction of certain other customary closing conditions.

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