BioNTech says the completion of its first inhouse plasmid DNA (pDNA) facility in Marburg, Germany aims to increase manufacturing flexibility and support its oncology and COVID-19 pipeline.
pDNA acts as an important starting material for the production of messenger RNA (mRNA) based therapeutic and vaccines, including cell therapies. The recently completed facility – which was acquired from Novartis in September 2020 – will enable BioNTech to independently manufacture pDNA for various clinical product candidates, as well as commercial products for cancer and infectious diseases.
However, the company cannot independently produce the majority of its own pDNA at the facility until it has received the relevant regulatory approvals.
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“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 Ugur Sahin, CEO 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 Marburg facility consists of two plants, which cover small-scale and large-scale pDNA production. The small-scale facility has been fully operational since August 2022 and BioNTech is using this space to manufacture plasmids for the company’s FixVac platform candidates, including investigational cancer immunotherapy, BNT111.
The firm expects the large-scale plant to be operational by the end of this year, although this is subject to regulatory approval. Additionally, BioNTech anticipates the plant to manufacture pDNA that can be used as starting material to produce several hundred million mRNA-based vaccine or therapy doses annually.
If peaks in pDNA demand occur, BioNTech will use partnered suppliers to cover the temporary increase. In turn, the firm hopes to up its flexibility and autonomy in producing starting materials for its pipelines and strengthen its independence for pandemic preparedness. Additionally, the firm says the Marburg facility will allow for quicker production cycles and reduced delivery times for pDNA.
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