HQ Team
February 3, 2023: BioNTech SE, an immunotherapy company, will invest $43 million in a new facility in Germany to make a vital ingredient for its mRNA drugs.
The facility in Marburg, Germany, will make plasmid DNA — a starting material for manufacturing mRNA-based vaccines and therapies, as well as cell therapies.
“Medical biotechnology is a key technology of the 21st century,” said Olaf Scholz, chancellor of Germany.
“The pandemic has proven Germany’s capability as a location for innovation and manufacturing of medicines. Germany and Europe are becoming more resilient by building local value chains. BioNTech’s investment is excellent news.”
With the new facility, BioNTech plans to independently manufacture plasmid DNA for clinical product candidates and commercial products in cancer and infectious diseases.
Partnered suppliers
Temporary peaks in demand will continue to be covered through partnered suppliers.
The new facility aims to increase BioNTech’s flexibility and autonomy in manufacturing starting materials for its oncology and COVID-19 vaccine pipelines, as well as the company’s independence for pandemic preparedness due to local production.
BioNTech also expects the new manufacturing facility to enable faster production cycles and shorter delivery times for plasmid DNA for several clinical and commercial product candidates.
“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.,” said Prof Augur Sahin, chief executive officer and co-founder of BioNTech.
Cover in-house
“Plasmid manufacturing is an exciting and important part of mRNA manufacturing that we expect to be able to cover in-house soon.
“We plan to manufacture mRNA-based products for a broad range of clinical trial candidates at our Marburg site while preparing production measures for the commercial manufacturing of personalized oncology therapeutics.”
The new facility comprises two plants covering clinical and commercial plasmid DNA manufacturing.
The clinical-scale plant has been operational since August 2022. In this plant, BioNTech is currently manufacturing plasmids for the ¸ompany’s FixVac platform product candidates, such as BNT111.
Commercial plant by 2023 end
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.
BioNTech’s site in Marburg is one of Europe’s largest manufacturing facilities for mRNA-based vaccines.
BioNTech has continuously invested in the site as part of its long-term development plan.
Technology hub
Beyond the already established commercial production of the Pfizer-BioNTech COVID-19 vaccine, the plan also includes growth areas such as a technology hub for innovative manufacturing solutions.
It will also manufacture mRNA vaccines on a clinical scale in support of the company’s clinical trials.
The plant will manufacture plasmid DNA to produce key starting materials for mRNA- and cell-based drugs in-house.
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, most of them in Germany, Spain, Belgium, the United Kingdom and the United States.
