CureVac N.V., a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), and Wacker Chemie AG announced that they had signed a contract 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.
WACKER’s CEO Rudolf Staudigl said: “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 Organization), 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, added: “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.
About CVnCoV
CureVac began development of its mRNA-based COVID-19 vaccine candidate in January 2020. The compound is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized 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.
About CureVac
CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. It is headquartered in Tübingen, Germany, and employs more than 500 people at its sites in Tübingen, Frankfurt, and Boston, USA.
About Wacker Biotech
Wacker Biotech GmbH and Wacker Biotech B.V. are full-service contract manufacturers of therapeutic proteins, LMPs and vaccines based on microbial systems. The company’s portfolio extends from strain/process development, through analytical testing, to production for clinical and commercial applications. Wacker Biotech maintains three GMP-compliant (Good Manufacturing Practice), FDA- and EMA-certified production plants at its German sites in Jena and Halle as well as in Amsterdam in the Netherlands. Wacker Biotech GmbH and Wacker Biotech B.V. are wholly owned subsidiaries of the Munich-based company Wacker Chemie AG (WCH888).
