Tim Wright, Editor, Contract Pharma01.29.21
Novartis has signed an initial agreement to leverage its manufacturing capacity and capabilities in order to address the COVID-19 pandemic by supporting the production of the Pfizer-BioNTech COVID-19 vaccine. The agreement will see Novartis utilizing its aseptic manufacturing facilities at its site in Stein, Switzerland.
Under the terms of the contract manufacturing agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world.
Subject to reaching a final agreement, Novartis plans to commence production in the second quarter of 2021 at its state-of-the art aseptic manufacturing plant in Stein. Initial shipment of finished product is expected in the third quarter.
The Novartis manufacturing team is in advanced discussions with a number of additional companies to take on manufacturing activities such as mRNA production, therapeutic protein production as well as raw material production for Covid vaccines and therapeutics. The specifics will be disclosed once those discussions are concluded.
“Novartis has been mobilizing on multiple fronts to support the global pandemic response,” said Steffen Lang, head of Novartis technical operations. “As a company reimagining medicine with advanced therapy platforms, we are committed to leverage our manufacturing capabilities to help support the supply of COVID-19 vaccines and therapeutics around the world. We expect this to be the first of a number of such agreements.”
The Pfizer-BioNTech COVID-19 vaccine has been authorized for use by the health regulatory authorities of about 50 countries, including Switzerland and the EU member states where it has been granted Conditional Marketing Authorization and it has received authorizations for emergency use in e.g. the UK, the U.S., and Canada, as well as in Hong Kong.
Under the terms of the contract manufacturing agreement, Novartis plans to take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world.
Subject to reaching a final agreement, Novartis plans to commence production in the second quarter of 2021 at its state-of-the art aseptic manufacturing plant in Stein. Initial shipment of finished product is expected in the third quarter.
The Novartis manufacturing team is in advanced discussions with a number of additional companies to take on manufacturing activities such as mRNA production, therapeutic protein production as well as raw material production for Covid vaccines and therapeutics. The specifics will be disclosed once those discussions are concluded.
“Novartis has been mobilizing on multiple fronts to support the global pandemic response,” said Steffen Lang, head of Novartis technical operations. “As a company reimagining medicine with advanced therapy platforms, we are committed to leverage our manufacturing capabilities to help support the supply of COVID-19 vaccines and therapeutics around the world. We expect this to be the first of a number of such agreements.”
The Pfizer-BioNTech COVID-19 vaccine has been authorized for use by the health regulatory authorities of about 50 countries, including Switzerland and the EU member states where it has been granted Conditional Marketing Authorization and it has received authorizations for emergency use in e.g. the UK, the U.S., and Canada, as well as in Hong Kong.
