BioNTech SE has signed a share purchase agreement with Novartis AG, to acquire their GMP certified manufacturing facility in Marburg, Germany. The manufacturing site will expand BioNTech’s COVID-19 vaccine production capacity by up to 750 million doses per year, or over 60 million doses per month, once fully operational. The transaction is expected to close in the 4Q20. BioNTech plans to produce up to 250 million doses of BNT162b2 in 1H21, with the established team and drug substance and drug product manufacturing capabilities at the site.

The Marburg production site is a state-of-the-art, multi-platform GMP certified manufacturing facility that currently employs approximately 300 people. It’s fully equipped for the production of recombinant proteins as well as cell and gene therapies, and has cell culture labs and viral vector production capabilities, with further potential growth and expansion.

The acquisition will accelerate BioNTech’s efforts to scale-up its commercial manufacturing capacity to produce its mRNA COVID-19 vaccine candidate BNT162. The BNT162 program includes five mRNA vaccine candidates currently in clinical testing in the United States, Europe, South America, and China. BioNTech and Pfizer are evaluating the lead candidate, BNT162b2, in a global Phase 3 trial.

The Marburg facility is expected to start the production of mRNA and the LNP formulation for a COVID-19 vaccine in 1H21, pending regulatory approval. BioNTech plans to manufacture additional therapeutic and vaccine drug candidates at the plant as well as to contribute to the production of the COVID-19 vaccine for global supply, subject to regulatory authorization or approval.

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Ben Locwin – Science & Public Health Task Force Member