GERMANY – BioNTech SE has completed the US$43 million (€40m) construction of its first proprietary plasmid DNA manufacturing facility in Marburg, Germany, to produce an important building block in mRNA-based drugs.

The development follows BioNTech’s acquisition of the manufacturing site in Marburg in the fall of 2020 and continuous investments in the site to expand its manufacturing capacities and capabilities.

The new manufacturing facility will fast-track BioNTech’s timeline for producing essential starting materials for mRNA- and cell-based drugs in-house. It is anticipated to be operational by the end of 2023.

In a press release, BioNTech SE said: “Plasmid DNA is an important starting material for the manufacturing of mRNA-based vaccines and therapies, as well as cell therapies.”

The biotechnology company outlined that a copy of a DNA sequence obtained from a plasmid can be used as a template to manufacture more than 500 mRNA strands.

Upon completion of the regulatory approval process, BioNTech plans to independently manufacture the majority of its current regular demand for DNA plasmids in the state-of-the-art plant in Marburg.

In addition to expanding its manufacturing capabilities and core competencies, the German-based immunotherapy company has expanded its presence in the genetic medicine space.

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 company said.

The company expects the new manufacturing facility to enable faster production cycles and shorter delivery times for plasmid DNA for clinical product candidates and commercial products in the areas of cancer and infectious diseases.

BioNTech confirmed that once its new facility is fully operational, temporary peaks in demand will continue to be covered through partnered suppliers.

With the new facility, BioNTech aims to increase its flexibility and autonomy in manufacturing of starting materials for the oncology and COVID-19 vaccine pipelines.

It will also bolster the Company’s independence for pandemic response and preparedness due to local production while positioning Germany as a location for innovation and manufacturing of medicines.

On his part, Prof. Ugur Sahin, M.D., Chief Executive Officer and Co-Founder of BioNTech, said: “We are preparing production measures for the commercial manufacturing of personalized oncology therapeutics.”

The plasmid DNA produced in Marburg is planned to be used globally and serve as the basis for manufacturing mRNA- and cell-based products on a clinical or commercial scale.

Moreover, it will expand BioNTech’s product pipeline which currently comprises 22 product candidates that are being evaluated in 26 clinical trials.

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