The acquisition lines up the site to produce the Pfizer-BioNTech mRNA COVID-19 vaccine candidate for global supply: expanding BioNTech’s production capacity by up to 750 million doses a year.
BioNTech already has two facilities in Germany producing the vaccine candidate for clinical trials. It expects a 'rapid transition' to vaccine production in Marburg, thanks to well-established biotechnology drug substance and drug product manufacturing equipment at the site, as well as an experienced team of 300 employees.
The acquisition of the Novartis facility is expected to complete in Q4 2020, with production of mRNA and the LNP formulation for a COVID-19 vaccine starting in the first half of 2021 (pending regulatory authorization or approval).
Manufacturing capabilities for mRNA manufacturing & vaccine formulation
The state-of-the-art, multi-platform GMP certified manufacturing facility is located one hour away from Frankfurt's international airport and 90 minutes from BioNTech's Mainz headquarters.
Novartis has ‘significantly invested’ in the site over the last five years: and as a result 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.
Dr. Sierk Poetting, CFO and COO at BioNTech, said: “This acquisition reflects BioNTech’s commitment to significantly expanding its manufacturing capacity in order to supply a potential vaccine worldwide upon authorization or approval.
"We are working closely with Novartis to prepare for a smooth transition, and we look forward to welcoming the new members of our team and tapping into their impressive skills and expertise.
"From a strategic standpoint, the new site will bolster our vertically integrated business model with in-house manufacturing capabilities for mRNA manufacturing as well as vaccine formulation.”
Once fully operational, the Marburg facility will have annual production capacity of up to 750 million doses - the equivalent of 60 million doses a month. It is set to begin production with up to 250 million doses in the first half of 2021.
COVID-19 vaccine production
The immediate role of the facility will be to scale-up BioNTech’s commercial manufacturing capacity for the Pfizer-BioNTech mRNA COVID-19 vaccine candidate, BNT162.
The lead candidate in the program – BNT162b2 – is currently in a global Phase 3 trial. Assuming clinical success, Pfizer and BioNTech intend to seek regulatory review as early as next month, with distribution of 100 million doses worldwide by the end of the year. The duo anticipate production of around 1.3 billion doses by the end of 2021.
The overall BNT162 program includes four other mRNA vaccine candidates in clinical testing in the US, Europe, South America, and China.
Pfizer also has at least four production sites in the US and Europe primed for the vaccine.
Among the destinations for the vaccine from Marburg will be China, where BioNTech is partnered with Fosun Pharma, subject to regulatory authorization or approval.
BioNTech says the site also holds potential for long-term growth and expansion. Looking past its COVID-19 vaccine, BioNTech plans to manufacture additional therapeutic and vaccine drug candidates at the facility: such as other mRNA vaccine, antibody, and cell and gene therapy product candidates in BioNTech’s cancer and infectious disease product pipeline.
The Marburg facility
The Marburg manufacturing site, named Behringwerke, was established in 1904 by Emil von Behring, who developed the antitoxin for Diphtheria and Tetanus. It was built with the award money von Behring received from the Nobel Prize in Medicine in 1901.
The facility situated in a life science industry park near Frankfurt which is home to more than 10 companies – among them GSK, CSL Behring, and Siemens Healthcare Diagnostics Products - with 6,000 employees in total.