It follows an earlier supply agreement for the fill and finish of more than 50 million doses in 2021 at the Novartis Stein site in Switzerland, which has been under way since June.
Novartis Technical Operations facility
Under the terms of the new initial agreement announced this morning, Novartis will take bulk mRNA active ingredient from BioNTech and fill this into vials under sterile conditions for shipment back to BioNTech for its distribution.
Novartis plans to transfer the manufacturing process from Stein to its Ljubljana site to commence the fill and finish in the first half of 2022. The Novartis Technical Operations facility in Ljubljana is a state-of-the-art aseptic filling operation which currently manufactures and supplies a broad range of aseptic products for Sandoz, a Novartis division.
Pfizer and BioNTech together expect to manufacture around 3 billion doses of their mRNA COVID-19 vaccine in 2021 and expect capacity to rise to 4 billion doses in 2022: driven by ongoing demand for initial vaccination and booster shots.
Increased capacity will be helped by manufacturing partnerships such as its agreements with Novartis. The European Medicines Agency’s human medicines committee (CHMP) this week approved two new additional manufacturing sites for the vaccine in Italy: one in Monza, operated by Patheon Italia S.p.A.; and the other in Anagni, operated by Catalent Anagni S.R.L.
Sites lined up for the future include Biovac's South Africa facility, which will start manufacturing doses in 2022 with capacity for more than 100 million doses a year. Further ahead, BioNTech will establish a fully-integrated mRNA manufacturing facility in Singapore, which is expected to become operational in 2023.