eTheRNA builds on more than 30 years of manufacturing research grade mRNA, and more than 5 years of GMP mRNA production. Following our foundation at the labs of the VUB in Brussels, since 2018 all RNA production is performed in our GMP approved facility in Niel, Belgium.
As an experienced RNA CDMO we now offer our expertise and capabilities as a one stop service to bring your RNA- based research and products from the lab to the clinic.
View our Manufacturing Capacity factsheet for more detailed information.
Ordering RNA can be an intricate process, so whether you’re interested in research grade material or in GMP production, the eTheRNA team are happy to support and guide you through the process. Our standard approaches and processes are scalable, from mg to g level, and we produce according to customer specification and with clinical phase appropriate controls.
Our services include plasmid development and production, research grade mRNA production and GMP grade mRNA production, including a wide range of options for purification and QC.
Based upon experience with own clinical trials, eTheRNA can also provide support in stability studies, purification and analytical method development and CMC file writing.
mRNA can be used in the following:
Here at eTheRNA, every RNA type is produced by in vitro transcription. This is usually mRNA, but very short RNA types such as guide RNA for CRISPR-CAS, or very long types such as Self Amplifying RNA are also possible. The main production steps involved in our RNA manufacturing include:
The following provides an overview of the QC methods eTheRNA’s Quality Department uses. The quality control testing may vary according to your final mRNA needs and clinical stage.
Construct optimization and screening for stability, expression and manufacturability
mg scale research grade production
scale up from mg to gram scale production for non-GLP and GLP toxicology trials
GMP production from mg to multigrade gram scale
scalable systems for large scale manufacturing
We know that ordering RNA can be a complex task and so we’ve put together this brief guide answering many of the common questions that we receive from our customers.
© 2021 eTheRNA | Studio Hanswijk