CDMO, CMO, Supplier Roundup in Supporting COVID-19 ProjectsBy
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Catalent, Celonic, and Exothera.
Celonic, CureVac in Mfg Pact for COVID-19 Vaccine
Celonic, a Basel, Switzerland-headquartered CDMO of advanced therapy medicinal products and mammalian cell line-expressed bio-therapeutics, and CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, have entered into a partnership for the production of CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV.
The companies entered into a commercial supply agreement to produce the vaccine at Celonic’s commercial manufacturing facility in Heidelberg, Germany. In total,Celonic will be prepared to manufacture more than 100 million doses of the vaccine. More than 50 million doses are expected to be produced before the end of 2021.
Under the terms of the initial agreement, technology and knowledge transfer is already underway (as reported on March 30, 2021). The commercial supply agreement includes manufacturing of the mRNA drug substance as well as lipid nanoparticle formulation of the bulk drug product.
CureVac reaffirms an expected output capacity of its broad European manufacturing network of up to 300 million doses in 2021.
Exothera, CyanVac in COVID-19 Vaccine Mfg Pact
CyanVac, an Athens, Georgia-based vaccine company, has selected Exothera, a Brussels, Belgium-based viral vector CDMO, for the development and manufacturing of CyanVac’s intranasal COVID-19 vaccine.
Exothera will be responsible for the fast-track development of a manufacturing process for CyanVac’s COVID-19 vaccine candidate to supply clinical trial materials for planned Phase III clinical studies in 2021. CVXGA1 will be manufactured at Exothera’s Vega GMP plant, one of two new GMP facilities located on the Univercells’ Jumet campus in Belgium. The Vega plant will produce the vaccine for both the European Union and US markets.
CVXGA1 is a COVID-19 vaccine candidate based on CyanVac’s proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2, the virus that causes COVID-19. CyanVac is developing CVXGA1 as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. CyanVac is planning to evaluate CVXGA1 in a Phase I clinical trial in the first half of 2021.
Formulation Development/Drug-Product Manufacturing
Catalent Dedicates Vial-Filling Line for Moderna’s COVID-19 Vaccine
Catalent and Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, have expanded their strategic collaboration to dedicate a new high-speed vial filling line for the manufacture of the Moderna’s COVID-19 vaccine and potentially other investigational programs at Catalent’s facility in Bloomington, Indiana.
In June 2020, Catalent and Moderna announced that Catalent would provide aseptic vial filling and packaging from its Bloomington site, including additional staffing required for 24 x 7 manufacturing to support production of an initial 100 million doses of Moderna’s vaccine. On March 29, 2021, Moderna announced that it had shipped the 100-millionth dose of its COVID-19 vaccine to the US government.
As part of theexpanded agreement, Catalent will now dedicate to Moderna use a new high-speed filling line at the site through June 2023, which can be used to manufacture the COVID-19 vaccine and potentially additional investigational programs from Moderna. Catalent will also provide inspection, labeling, cartoning, and final packaging for these programs.
In September 2020, Catalent announced a $50-million investment into a third high-speed vial filling line at the Bloomington site, which will now dedicated to Moderna, and which will be completed in April 2021.