Wacker CDMO Arm to Produce CureVac Vaccine
Germany’s Wacker Chemie has signed a contract to manufacture the active substance for compatriot CureVac’s Covid-19 vaccine candidate CVnCoV. Under the terms, the biotech arm of the Munich-based chemical group will ramp up GMP production of the mRNA drug substance for the candidate at its Amsterdam site in the first half of 2021.
Preparations for the start of production, technology transfers and test runs are already under way, with the plan calling for production of more than 100 million doses of the vaccine per year at Amsterdam, Wacker said, noting that there is potential for expansion at the site in order to meet rising demand in the future.
The Amsterdam site has been producing vaccines for clinical development and commercial supply for 20 years. Its portfolio ranges from conventional live and killed vaccines to protein-based, polysaccharide and glycoconjugate vaccines. Recently, Wacker’s wholly biotech offshoot has invested in the Dutch premises to extend production to mRNA-based vaccines.
Rudolf Staudigl, CEO of Wacker Chemie, said the group is “proud and highly motivated to make a contribution to the fight against the spread of the coronavirus pandemic together with CureVac.”
The Tübingen-based biotech is building an integrated European vaccine manufacturing network with several CDMO partners. With this strategy, chief production officer Florian von der Mülbe said, the vaccine maker will “significantly increase” manufacturing capacity up to several hundred million doses per year and will manage potential supply chain risks by working with several partners for each of the key manufacturing process steps.
CureVac began development of its mRNA-based Covid-19 vaccine candidate in January 2020. Phase 1 and 2a clinical trials with the candidate began in June and September 2020 respectively. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus.
Wacker Biotech maintains three GMP-compliant FDA- and EMA-certified production plants at its German sites in Jena and Halle as well as at Amsterdam.
Author: Dede Williams, Freelance Journalist
