Biopharmaceutical production 4.0 – Welcome to the future

A universal system that enables the standardized manufacturing of a myriad of therapeutics and vaccines may sound like science fiction. However, CureVac’s RNA platform allows for precisely this to occur today, making production possible in a flexible, quick and cost-effective manner.

It‘s all about information! – Biopharma meets IT

Instead of an active pharmaceutical ingredient, CureVac’s RNA technology provides our body with customized information, which it can use to produce the required active ingredient or vaccine itself in vivo. In this regard, the production process of our RNA therapeutics is similar to a programming procedure in the field of IT. Instead of writing a digital code at a computer, we program the RNA molecule to address a specific medical need. In each case – whether programming a computer or RNA – the carrier medium is always the same, however, the coded information varies depending on the purpose and objective at hand. This principle results in the possibility to produce all RNA constructs with the same process in the same plant.

CureVac has developed the entire, end-to-end manufacturing process itself and has extensive intellectual property covering its production techniques and technologies. From the source material DNA to the finished product, we can map out the entire course of product development.

Manufacturing according to our value-added process

Depending on the objective and the required RNA quantity, the right process and production standards are  at our disposal. In this way, we can manufacture hundreds of different test candidates using the same source materials in a parallelized manner for our research within the scope of a high-throughput procedure. 

Once the RNA construct is developed, we can generate large quantities for preclinical testing, and produce RNA in our GMP plants according to the highest standard for use in humans.

Integral to this process is our PureMessenger® method for RNA, which enables CureVac to produce RNA therapies in a highly pure form, ensuring a consistently high and comparable level of RNA quality, thereby guaranteeing transferability of the results.

GMP production setting fully new standards

One for all – universal platform process

CureVac’s production process, standardized for all RNA constructs, offers significant potential in that all products can be designed and developed at a single facility. RNA active ingredients for treating a wide variety of diseases and protecting against various infectious diseases can be manufactured in the same plant. CureVac has secured extensive patent protection of this process.

For comparison: The production of other biopharmaceutical medications generally requires a plant to be designed and built for each individual product.

Flexible multi-product plant

Our GMP plant can be switched to a new product within just a few hours, whereby the source materials are always the same. This platform process eliminates the need to develop new validation concepts for new products.

For comparison:
The GMP-compliant production of other active ingredients must be planned far in advance, since the plant must be specially built for each product and has to be approved. Often, the quantity to be produced cannot vary in the process.

Quick production

Using the biotechnological in-vitro process, which uses only naturally occurring components as source materials, we can produce any RNA sequence within just a few weeks in GMP quality. This allows for prompt availability of vaccines in the event of a pandemic.

For comparison: In the case of regular biopharmaceutical production processes, manufacturing may take several months depending on the product.

Low manufacturing costs per dose

Our universal production process enables us to significantly reduce the manufacturing cost per dose.

For comparison: The manufacturing costs for common biopharmaceutical production processes are often very high since the production is very time-consuming and complex.

Scalable process

The production process developed by CureVac can be scaled according to the required quantities: from small, customized batches to a full, commercial-scale output.

For comparison: In the case of other existing biopharmaceutical manufacturing plants, the once determined capacity cannot be scaled without breaking up the process itself.

Reproducible system

CureVac’s universal process plant developed for the manufacturing of RNA active ingredients can be easily reproduced and set up at other locations. Thereby, it is possible to manufacture active ingredients at the precise moment they are needed.

For comparison: Common active ingredient production processes can mostly not be reproduced in their complexity since "copies" are practically impossible.

Temperature-stable final product

Our mRNA products are temperature-stable and do not need to be cooled during storage and transport. Therefore, the medications arrive quickly and intactly at their destination and can therefore be used in all parts of the world without extensive logistical effort or high costs.

For comparison: Most drugs have to be continuously cooled during storage and transport in order to not endanger their effectiveness.