BioNTech said the Marburg facility will become one of the largest mRNA manufacturing sites in Europe and the third site in its own manufacturing network in Germany expected to produce BNT162 for global supply.

The transaction with Novartis is due to close in the upcoming fourth quarter. BioNTech  hopes to be able to produce up to 250 million doses of the vaccine candidate in the first half of 2021, leveraging the site’s established team, along with its  well-established drug substance and drug product manufacturing capabilities.

Novartis’ Marburg plant is a state-of-the-art, multi-platform GMP certified manufacturing facility that currently employs around 300 staff, all of which will transfer to the new owner.  The fully equipped infrastructure will facilitate production of recombinant proteins as well as cell and gene therapies, cell culture labs and viral vector production capabilities, with further potential for long-term growth and expansion, BioNTech said.

Over the past five years, the Basel-based drugmaker has significantly invested in the Marburg site located in a life science industry park that is home to more than 10 companies with 6,000 employees. As part of the erstwhile Behringwerke, the location has a long history of vaccine development.

BioNTech said it expects to operate the former Novartis plant as one of the largest mRNA manufacturing sites in Europe alongside two of its existing GMP facilities currently producing the Covid-19 vaccine candidates for clinical trials and in addition to at least four Pfizer production sites in the US ta and Europe.

The Marburg facility is expected to start production of mRNA and the LNP formulation for the Covid vaccine in the first half of 2021, pending regulatory authorization or approval of the candidate.

In addition to the coronavirus vaccine, BioNTech plans to manufacture additional therapeutic and vaccine candidates at Marburg, including other mRNA vaccines and antibody and cell and gene therapy product candidates. This will support the development of its diversified cancer and infectious disease product pipeline.

The plant is also envisioned to contribute to production of the Covid vaccine for global supply, including China, where BioNtech is partnered with Fosun Pharma.

Sierk Poetting, chief financial officer and chief operating officer at BioNTech, said the facility’s acquisition reflects the company’s commitment to significantly expanding its manufacturing capacity in order to supply a potential vaccine worldwide upon authorization or approval.

BioNTech’s BNT162 program includes five mRNA vaccine candidates currently in clinical trials in the US, Europe, South America and China. BioNTech and Pfizer are evaluating the lead candidate, BNT162b2, in a global Phase 3 trial. 

Author: Dede Williams, Freelance Journalist