Novartis in Mfg Pact for Pfizer’s COVID-19 VaccineBy
Novartis has signed a new agreement to fill–finish Pfizer’s/BioNTech’s COVID-19 vaccine. Novartis will use its sterile manufacturing facilities in Ljubljana, Slovenia, to fill at least 24 million doses in 2022. The new agreement follows an earlier supply agreement for the fill–finish of more than 50 million doses in 2021 at Novartis’ site in Stein, Switzerland.
Under the new initial agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under sterile conditions for shipment back to BioNTech for its distribution. Subject to reaching a final agreement, Novartis plans to transfer the manufacturing process from its site in Stein, Switzerland, to its site Ljubljana, Slovenia, to begin fill–finish in the first half of 2022. The facility in Ljubljana is an aseptic filling operation that manufactures and supplies a broad range of aseptic products for Sandoz, a Novartis division.
This new agreement follows a first contract signed earlier this year (2021). Novartis started filling for BioNTech at its site in Stein, Switzerland in June (June 2021) following the approval of the fill–finish plant by the European Medicines Agency