GMP production facility
CureVac is developing a new good manufacturing practice (GMP) compliant ribonucleic acid (RNA) production facility at its German headquarters in Tubingen.
Planned to manufacture 30 million doses of RNA-based therapeutics a year, production is scheduled to commence in 2018, while commissioning is expected to be completed in 2019.
The new facility will expand CureVac’s manufacturing capabilities and meet growing demands for clinical trials and product commercialisation.
Construction of the GMP IV facility began in October 2017.
With a floor space of 8,800m², the new facility will be used to produce a wide range of RNA-based products including RNActive®, RNArt®, RNAntibody® and RNAdjuvant®. These products are approved for indications such as cancer, infectious diseases and other illnesses.
The plant will also have the potential for future expansions.
The RNA active ingredients made at the plant can be used to treat various diseases and infections. A patent-protected production process is standardised for all RNA constructs.
The plant is able to manufacture multiple products, smoothly switching from one production method to another in a few hours. The platform also eliminates the need to develop validation concepts for new products.
Production processes can be scaled according to different quantities ranging from small and customised batches to commercial-scale output.
The GMP-compliant plant will be used to produce vaccines in the event of a pandemic. Vaccines can be made quickly using a biotechnological in-vitro process that uses naturally occurring components as source materials.
The plant will also adhere to the PureMessenger® method of production, which ensures pure and consistently high RNA quality. It will be equipped to manufacture new RNA sequences in GMP quality within a few weeks. The production process also significantly minimises the cost per dose.
CureVac’s proprietary technology uses mRNA as a data carrier to instruct the human body to produce proteins capable of fighting various diseases. The company’s technologies are used to develop cancer drugs, vaccines and molecular therapies.
Established in 2000, CureVac is a biopharmaceutical company, which was a spin-off from the University of Tϋbingen.
It is one of the first companies to have initiated clinical trials on mRNA-based drugs and has more than 17 years of experience in producing RNA molecules for various medical needs.
CureVac has been operating GMP-compliant RNA production plants GMP I and GMP II since 2006. It also recently completed GMP III, a third in-house suite for manufacturing RNA products.
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