Since 2006, CureVac has operated the first GMP-compliant production plant worldwide with two multi-product suites – GMP I and GMP II – for large RNA molecules for medical applications against cancer, infectious diseases and other illnesses. Since 2008, these suites have supplied mRNA for CureVac’s multiple clinical studies.

The RNA company is advancing by taking its GMP production capabilities to the next level. CureVac is currently completing the development of its third in-house suite, GMP III. This suite will operate under a newly developed and patent-protected process optimized for large scale production. Manufacturing of RNA products in this facility will begin in 2018.

Expanding its manufacturing capabilities is CureVac’s construction of a new building, which is designed for the development of a GMP production process on an industrial scale. Construction has now started; the new facility, GMP IV, is expected to be fully commissioned in 2019 and is designed with a modular concept that gives CureVac the ability to rapidly adapt to product development needs. GMP IV’s production process design will cover a wide variety of different RNA-based products and is planned to begin with a target capacity of approximately 30 million doses per year. CureVac also has the ability to extend the building to fulfill future market needs for its RNA products onsite in Tübingen.

Florian von der Mülbe, Ph.D., co-founder and Chief Operating Officer of CureVac, stated, “At CureVac, we believe it is mission-critical to produce high quality RNA products for all development stages, from research to clinical grade, and to drive product development forward. With the construction of GMP IV, we are in a great position to be the first RNA company with commercial-scale production know-how and capabilities. Our expertise in RNA production makes us ideally positioned to also extend relationships with both existing partners and future collaborators.”

Since its foundation in 2000, mRNA pioneer CureVac continuously increases its expertise and know-how in formulating, optimizing and manufacturing the versatile molecule, mRNA. Using mRNA for medical treatment became one of biotech’s hotspots within the last years.