Contract Development and Manufacturing Organization Celonic and German biopharmaceutical company CureVac have entered into an agreement to manufacture 100 Million doses of CureVac’s COVID-19 Vaccine Candidate, CVnCoV.
CureVac, a biopharmaceutical company creating a new generation of innovative drugs focused on messenger ribonucleic acid (mRNA), and Celonic Group a premium biopharmaceutical CDMO dedicated to the development and manufacturing of Advanced Therapy Medicinal Products (ATMPs) and mammalian cell line-expressed bio-therapeutics announced on the 30th of March a collaboration agreement to jointly manufacture CureVac’s mRNA-based COVID-19 vaccine candidate, CVnCoV.
100 million doses of CVnCoV to be manufactured at biologics and ATMPs plant in Heidelberg, Germany
Celonic has agreed to manufacture CureVac’s coronavirus vaccine candidate at its state-of-the-art industrial manufacturing plant for biologics and ATMPs in Heidelberg, Germany. The Heidelberg site is comprised of facilities spanning 1250 sqm including clean rooms of class B, C or D for GMP production and quality control. Celonic plans to produce over 100 million doses of CVnCoV in total as more than 50 million doses are expected to be produced by the end of 2021.
Technology and information sharing are now ongoing under the provisions of the original arrangement. Manufacturing of the mRNA drug material and LNP formulation of the bulk drug product are included in the industrial supply arrangement.CureVac reaffirms an expected output capacity of its broad European manufacturing network of up to 300 million doses in 2021.
Dr. Florian von der Mülbe, Chief Production Officer of CureVac stated:
“Manufacturing of sufficient quantities of vaccine is critical to combating the COVID-19 pandemic. With this partnership, we are further extending our integrated European manufacturing network, reinforcing the overall production capacity for our COVID-19 vaccine candidate, CVnCoV.”
Dr. Konstantin Matentzoglu, Chief Executive Officer of Celonic added:
“Since the onset of the pandemic, Celonic has committed extensive breadth of complex bio-solutions development expertise and manufacturing resources to this global challenge. We have invested heavily to support our partners in bringing novel COVID-19 therapeutics and vaccines to patients, at an accelerated pace. Celonic is proud to collaborate with CureVac as part of an expansive manufacturing network in this global fight against COVID-19 by contributing to the production of its mRNA-based COVID-19 vaccine candidate, CVnCoV. With a dedicated and highly motivated team in place, Celonic is well positioned to have produced the first 50 million doses before end of 2021.”
About the CVnCoV mRNA-based COVID-19 vaccine candidate
In January 2020, CureVac started developing mRNA-based COVID-19 vaccine candidates. CVnCoV is the vaccine candidate selected for initial clinical development, and is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus, formulated within Lipid Nanoparticles (LNPs). CVnCoV’s Phase 1 and 2a clinical trials started in June and September 2020, respectively.
CVnCoV was generally well-tolerated overall testing doses administered, eliciting robust antibody responses as well as the first signs of T cell activation, according to Phase 1 interim results released in November 2020. The immune response was similar to that of recovered COVID-19 patients, closely resembling that of a normal immune response after a natural COVID-19 infection.
In December 2020, CureVac initiated a pivotal Phase 2b/3, the HERALD study, with a 12µg dose of CVnCoV. CureVac began a rolling submission to the European Medicines Agency (EMA) for CVnCoV in February 2021.CureVac has formed a number of strategic alliances in order to advance the development, manufacturing, and commercialization of CVnCoV.
In January 2021, the company established a partnership deal with Bayer for CureVac’s latest CVnCoV, which is presently in clinical Phase 2b/3. CureVac and GlaxoSmithKline (GSK), a British pharmaceutical firm, decided in February 2021 to collaborate on the development of next-generation mRNA vaccines against COVID-19. The development of new vaccine candidates is strengthened by a partnership with the UK Government and its Vaccines Taskforce, which CureVac also entered in February 2021.