Rentschler Biopharma is poised to begin large-scale production of CureVac´s candidate COVID-19 vaccine, CVnCoV. Meanwhile Bayer will ramp up production, and GSK is on board to make a further 100 million doses this year.
Rentschler, a German contract development and manufacturing organization (CDMO) announced it is gearing up to start commercial production at its Laupheim facility this week. It said it is optimizing the process to increase mRNA yield, adding it expects to produce more than 100 million doses per year.
A Rentschler spokesperson told us the CDMO “will be responsible for manufacturing, downstream processing and formulation,” adding that this will involve mRNA production, API purification and formulation. Fill-finish will not be carried out by Rentschler.
Image: iStock/Kirill Reznichenko
The spokesperson also said “we have been hiring actively and are currently still looking to hire up to 80 highly qualified new team members, such as lab technicians and bioprocess engineers, to contribute to this important project and help us satisfy the increasing demand for life-saving biopharmaceuticals in the long-term.”
CureVac contracted Rentschler as its manufacturing partner in November. The biotech is also working with Bayer, Wacker and Fareva on production of the vaccine, which is currently in Phase II/IIIb development.
Big Pharma on board
Rentschler’s announcement comes a day after Bayer confirmed plans to ramp up production.
Bayer said it will make “an additional 160 million doses of CureVac’s vaccine in 2022 to further expand their supply network and overall capacity.”
And today, GlaxoSmithKline has struck a €150 million ($180 million) deal with CureVac to both develop next generation mRNA COVID-19 vaccines and to support production of CVnCoV.
Under terms of the deal, GSK will produce up to 100 million doses of the vaccine this year from its manufacturing network in Belgium.
Vaccine
CureVac began developing CVnCoV in January 2020. The vaccine is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus. It is formulated within Lipid Nano Particles (LNPs).
In contrast with COVID-19 vaccines developed by Pfizer and BioNTech and Moderna, CureVac’s candidate can be stored at 5 degrees C which, according to the firm, will simplify distribution and logistics.
In November, CureVac chief production officer Florian von der Mülbe said, “Transport and storage of vaccines requiring ultra-low temperature setups to keep them stable, has been the topic of intense discussions and concerns in terms of feasibility, added costs and wastage.
“We are very encouraged by the emerging stability profile of our COVID-19 vaccine candidate compatible with standard fridge-temperature storage as well as a required room temperature application.
“This compatibility has the potential both to enable decentralized storage and to significantly facilitate large-scale vaccination efforts during the current pandemic.”