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.
The €40m ($43.8m) investment in the facility will provide both small scale clinical and large scale commercial plasmid DNA manufacturing.
Potential for several hundred million vaccine doses annually
The clinical scale plant has been operational since August, with BioNTech already manufacturing plasmids for its FixVac platform product candidates: such as lead candidate BNT111, an investigational cancer immunotherapy for the treatment of advanced melanoma which is in Phase 2 trials.
The commercial plant is anticipated to be operational by the end of 2023, subject to regulatory approval.
Plasmids are small, ring-shaped DNA sequences that can occur in bacteria in addition to their genomic DNA. They often encode additional acquired genetic information which for instance can confer antibiotic resistance on the bacterium.
Plasmids are used in the biopharmaceutical industry as vectors or transport vehicles for, amongst other things, the multiplication of genetic information or DNA sequences. A copy of a DNA sequence obtained from a plasmid can be used as a template to manufacture more than 500 mRNA strands.
After mRNA manufacturing, the DNA templates are filtered and discarded, and are therefore not part of the final vaccines or therapies.
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.
Once the facility is fully operational and has gained the required regulatory approvals, the company plans to independently manufacture the majority of its own current regular demand for DNA plasmids in the new manufacturing facility.
It says the new facility will enable faster production cycles and shorter delivery times for plasmid DNA for a number of clinical product candidates and commercial products.
Temporary peaks in demand will continue to be covered through partnered suppliers.
BioNTech says this model will increase its flexibility and autonomy in manufacturing starting materials for its oncology and COVID-19 vaccine pipelines, as well as boosting pandemic preparedness.
Investing in Marburg
BioNTech acquired the Marburg site from Novartis in 2020: and has since created one of the largest manufacturing facilities for mRNA-based vaccines in Europe.
As part of its long-term development plan, BioNTech has continued to invest in the site, with the number of employees doubling to around 700 since the acquisition of the site.
German Chancellor Olaf Scholz is visiting the new manufacturing facility in Marburg today (Feb 2) together with BioNTech co-founders Prof. Ugur Sahin, M.D., Chief Executive Officer, and Prof. Özlem Türeci, M.D., Chief Medical Officer.
“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.
“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.”
BioNTech’s product pipeline currently consists of 22 product candidates across 26 clinical trials.