In-house GMP production

Since 2006, CureVac has its own GMP-compliant production plant for large RNA molecules designated for medical application. We were the first company worldwide to develop this process and obtain regulatory approval. The company’s own plant has been validated by government authorities (e.g. PEI, FDA, Swissmedic) and has received manufacturing authorization for numerous clinical studies.

Manufacturing is subject to strict regulatory controls. Good Manufacturing Practice (GMP) comprises a continuously high level of product quality, documentation of all work steps, as well as the regular inspection of laboratories, equipment, supplier operations and source materials.

A broad patent basis protects the standardized production process for RNA active ingredients, developed by CureVac.

All of our RNA-based active ingredients for various fields of application originate from a common technology platform and are based on identical source materials. This enables CureVac to produce all RNAs using a universal process – even at a GMP level of quality.

• Complete infrastructure of the manufacturing of DNA templates, all the way to filling of the final product
• One reproducible production plant for all products
• Standardized production process for all RNA constructs
• Quick switch to new products
• Scale-up for industrial manufacturing possible

We are expanding our existing production capacities and are building additional GMP plants at our headquarters in Tübingen, Germany, to meet the increasing demand for clinical studies and future commercial supply.