BioNTech is acquiring a GMP manufacturing site from Novartis to expand its COVID-19 vaccine production capacity in the first half of 2021.
Based 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 fourth quarter of 2020. The company plans to be able to produce up to 250 million doses of BNT162b2 in the first half of 2021, thanks to the established team and well-established 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 is fully equipped for the production of recombinant proteins as well as cell and gene therapies, and holds cell culture labs and viral vector production capabilities, with further potential for long-term growth and expansion.
Novartis has significantly invested in the site over the past five years, which is located in a life science industry park that is home to more than 10 companies with 6,000 employees in total, and also provides an excellent infrastructure for the company.
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 US, Europe, South America, and China. BioNTech and Pfizer are evaluating the lead candidate, BNT162b2, in a global Phase 3 trial.
The facility is expected to operate as one of the largest mRNA manufacturing sites in Europe alongside two of BioNTech’s existing GMP facilities which currently produce the COVID-19 vaccine candidates for clinical trials, and in addition to at least four Pfizer production sites in the US and Europe.