BioNTech SE has completed construction of the company’s first proprietary plasmid DNA manufacturing facility in Marburg, Germany.
 
Plasmid DNA is an important starting material for the manufacturing of mRNA-based vaccines and therapies, as well as cell therapies. With the new facility, BioNTech plans to independently manufacture plasmid DNA for clinical product candidates and commercial products in the areas of cancer and infectious diseases.
 
BioNTech plans to independently manufacture the majority of its own current regular demand for DNA plasmids in the new manufacturing facility, once it is operational and pending regulatory approvals. Temporary peaks in demand will continue to be covered through partnered suppliers. This aims to increase BioNTech’s flexibility and autonomy in manufacturing of starting materials for its oncology and COVID-19 vaccine pipelines as well as the Company’s independence for pandemic preparedness due to local production. The Company also expects the new manufacturing facility to enable faster production cycles and shorter delivery times for plasmid DNA for a number of clinical product candidates and commercial products.
 
“Since we acquired our manufacturing site in Marburg in the fall of 2020, we have continuously invested in the site to expand our manufacturing capacities and capabilities. Plasmid manufacturing is an exciting and important part of mRNA manufacturing that we expect to be able to cover in-house soon,” said Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech. “We plan to manufacture mRNA-based products for a broad range of clinical trial candidates at our Marburg site while we are preparing production measures for the commercial manufacturing of personalized oncology therapeutics.”
 
The new manufacturing facility comprises two plants covering both clinical (small scale) and commercial (large scale) plasmid DNA manufacturing. The clinical-scale plant has been operational since August 2022. In this plant, BioNTech is currently manufacturing plasmids for the Company’s FixVac platform product candidates, such as BNT111. BioNTech expects to manufacture plasmid DNA that can be utilized as starting material to manufacture mRNA for several hundred million vaccine doses or therapies annually, depending on the product or product candidate. The commercial plant is anticipated to be operational by the end of 2023, subject to regulatory approval. BioNTech expects a total investment of around €40 million in the new manufacturing facility.
 
BioNTech’s site in Marburg is one of the largest manufacturing facilities for mRNA-based vaccines in Europe. As part of its long-term development plan, BioNTech has continuously invested in the site and more than doubled the number of employees to around 700 over the past two years.
 
Beyond the already established commercial production of the Pfizer-BioNTech COVID-19 vaccine, the development plan also includes three additional potential growth areas:
 

• A technology hub for innovative manufacturing solutions such as the BioNTainer, which encompasses the first two fully-operational modular production facilities on-site.
• The manufacturing of mRNA vaccines on a clinical scale in support of the Company’s clinical trials. The focus here is currently on candidates from the Company’s proprietary FixVac platform.
• Plasmid DNA manufacturing to produce key starting materials for mRNA- and cell-based drugs in-house.

 
The plasmid DNA produced in Marburg is planned to be used globally and serve as the basis for the manufacturing of mRNA- and cell-based products on a clinical or commercial scale. BioNTech’s product pipeline currently comprises 22 product candidates that are being evaluated in 26 clinical trials. The Company is conducting clinical trials in more than 30 countries worldwide.