WACKER Chemie has signed a contract with biopharmaceutical company, CureVac, for the manufacturing of CureVac’s COVID-19 vaccine candidate CVnCoV.
Under the terms of the initial agreement, WACKER will ramp up GMP (Good Manufacturing Practice) production of the mRNA drug substance for CVnCoV at its biotech site in Amsterdam in the first half of 2021. Preparations for the start of production, technology transfers and test runs are already underway. It is planned to produce more than 100 million doses of the CureVac vaccine per year at WACKER’s Amsterdam site. There is also further potential for expansion at the site in order to meet rising demand in the future.
Fight against COVID-19
WACKER’s CEO Rudolf Staudigl says: “We are proud and highly motivated to make a contribution to the fight against the spread of the coronavirus pandemic together with CureVac.” As a CDMO (Contract Development and Manufacturing Organisation), Wacker Biotech bundles WACKER Group’s biopharmaceutical activities. Its Amsterdam site has been producing vaccines for clinical development and commercial supply for 20 years. The portfolio ranges from conventional live and killed vaccines to protein-based, polysaccharide and glycoconjugate vaccines. In recent months, WACKER has invested in the site to extend production to include mRNA-based vaccines. This new class of vaccines expands the broad vaccine portfolio Wacker Biotech offers to its customers.
Dr Florian von der Mülbe, chief production officer of CureVac, adds: “With WACKER, we have found a committed and highly experienced partner for the production of our vaccine candidate in the Netherlands.” CureVac is building an integrated European vaccine manufacturing network with several CDMO partners. With this strategy, the company will significantly increase the manufacturing capacity already existing within CureVac for CVnCoV 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. The compound is an optimised, non- chemically modified mRNA, encoding the prefusion stabilised full-length spike protein of the SARS-CoV-2 virus. Phase 1 and 2a clinical trials of CVnCoV began in June and September 2020, respectively. Phase 1 interim data reported in November 2020 showed that CVnCoV was generally well tolerated across all tested doses and induced strong antibody responses in addition to first indication of T cell activation. The quality of immune response was comparable to recovered COVID-19 patients, closely mimicking the immune response after natural COVID-19 infection. The data support CureVac’s decision to advance a 12μg dose in its upcoming pivotal Phase 2b/3 study, which CureVac plans to initiate before the end of 2020.
Clinical trial material is provided by the company’s substantial production capacities for mRNA vaccines at its headquarters in Tübingen, supported by the current expansion of manufacturing capacities to allow for broad-scale manufacturing of CVnCoV for potential commercial supply preparedness.