BioNTech and its partner Pfizer have multiple COVID-19 vaccine supply deals in the bag, and a major production expansion is due.
BioNTech has agreed to buy a biologics facility in its home country from Novartis, the German biotech said Thursday. Expected to be fully operational in the first half of 2021, the Marburg site could have annual capacity of up to 750 million doses of the company’s experimental mRNA shot, BNT162.
As Novartis has already invested more than $109 million in the site since settling in there in 2015, BioNTech expects a quick turnaround once the transaction closes by year’s end. It plans to produce up to 250 million doses of BNT162b2, currently the lead candidate among five in the BNT162 program, in the first half of 2021.
The GMP-certified facility employs about 300 people, who will join the German company.
The location is a perfect fit for BioNTech in several ways. It boasts a history of vaccine manufacturing; it was previously used by Novartis’ former vaccine division until the vaccines-for-oncology asset swap with GlaxoSmithKline in 2015. Since then, it’s been used to produce biologics and cell and gene therapies, Novartis said on its website.
Founded in 1904 and funded by 1901 Nobel Prize in Medicine laureate Emil von Behring, the site is located in a life science park with a highly established infrastructure. What’s more, it’s located within one-hour driving distance from the Frankfurt airport and is also just a 90-minute drive away from BioNTech’s headquarters in Mainz, Germany.
BioNTech now plans for the site to handle the first three steps of manufacturing its mRNA hopeful: mRNA production, drug substance purification and concentration, and formulation.
Two other existing BioNTech facilities are producing the company’s COVID-19 vaccine candidates for clinical trials, and Pfizer has tagged three sites in the U.S. and one in Belgium for the project. Addition of the Marburg facility will give the two firms much-needed commercial bandwidth to handle a growing list of preorders and meet their ambition of producing 1.3 billion doses by the end of 2021.
In the U.S., the pair has penned a contract with the HHS to supply up to 600 million doses. They also agreed to allocate 30 million doses to the U.K. and 120 million doses to Japan, and are also working to close a deal with the EU for up to 300 million doses. Plus, BioNTech is on the hook for supplying its Chinese partner, Fosun Pharma, which kicked off a local phase 1 trial in August.
Globally, BNT162b2 is one of the most advanced programs in clinical development. Enrollment in its phase 3 efficacy trial is progressing as projected, with about 29,000 volunteers having been enrolled across 129 sites, according to BioNTech. The two companies recently said they intend to increase the size of the trial to 44,000 participants, up from the original 30,000.
Besides the COVID-19 hopeful, BioNTech said it plans to manufacture other therapeutic and vaccine candidates at the plant, including other mRNA vaccines, antibodies, and cell and gene therapies for cancer and infectious disease in its pipeline.