Our RNA Expertise for Your Projects
eTheRNA manufacturing 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.
About RNA Manufacturing
Ordering RNA can be an intricate process, so whether you’re interested in research grade material or in GMP production, the eTheRNA manufacturing 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 manufacturing can also provide support in stability studies, purification and analytical method development and CMC file writing.
Why Work With Etherna
- Over 30 years of research grade mRNA manufacturing, and more than 5 years of GMP mRNA production
- Our processes are scalable, from mg to g level
- We produce according to customer specification and with clinical phase appropriate controls
Application
mRNA can be used in the following:
- mRNA vaccines
- cell therapy
- gene editing
- protein replacement
- antibodies
- pandemic response
Here at eTheRNA manufacturing, 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:
- Synthesis of synthetic DNA
- Plasmid cloning
- Plasmid purification
- Full DNA sequencing documentation
- PCR amplification of insert, purification and characterization
- In vitro transcription
- Purification and characterization
- Bioburden reduction or sterile filtration
Quality control
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.
- Concentration
- Purity/integrity
- Identity
- Potency
- Residual protein
- Residual plasmid DNA
- Residual dsRNA
- Poly(A) tail analysis
- Capping efficiency
- Bioburden
- Endotoxin
- Appearance
- pH
- Osmolality
Our RNA Production Support Lifecycle
Early Phase Discovery
Construct optimization and screening for stability, expression and manufacturability
Late Phase Discovery
mg scale research grade production
Preclinical Support
scale up from mg to gram scale production for non-GLP and GLP toxicology trials
Phase 1 to 3
GMP production from mg to multigrade gram scale
Commercial
scalable systems for large scale manufacturing