Manufacturing
Advanced Technology Boosting Immunotherapy
eTheRNA builds on more than 30 years of mRNA manufacturing experience. Since 2018, all RNA production is performed in the brand new GMP authorized facility in Niel, Belgium.
We now offer our expertise and capability to other parties interested in having their RNA manufactured according to their needs. We produce both non-GMP or research grade material and GMP grade material to be used in clinical trials.
Plasmid DNA
eTheRNA has extensive experience in the design and production of plasmid DNA (pDNA) for RNA transcription and has developed a standardized approach to produce the best in class plasmids for your projects.
Specifications:
- Concentration
- Homogenicity
- Identity
- Endotoxin content
- Bioburden
Research Grade RNA
We can manufacture the following RNA types by in vitro transcription:
- mRNA
- Long RNA
- Guide RNA
with sizes from about 200 to 10000 nt
The RNA can be made by using regular or modified NTP’s, and with different cap-analogs (CAP1, CAP0).
Specifications:
- Concentration
- Integrity
GMP Grade RNA
We can manufacture the following RNA types by in vitro transcription:
- mRNA
- Long RNA
- Guide RNA
with sizes from about 200 to 10000 nt
The RNA can be made by using regular or modified NTP’s, and with different cap-analogs.
Specifications:
- Visual inspection
- Appearance
- Integrity
- Identity
- pDNA content
- Protein content
- Endotoxin content
- Concentration
- Potency
- Sterility
- RNA sequence
Services
Validation & Verification
Validation and verification of processes and methods
Inbound technology transfer
Technology transfer of your developed processes to our facilities to prepare for upscaling
Stability studies
Stability studies in different conditions on API, IMP or reconstitution buffers
Supply of reconstitution buffers
Storage of inventory at 15-25°C, 2-8°C, -15°C
Storage of WCD at –80°C
Development activities
- Process development
- Purification development
- Analytical method development
- Upscaling
Galileilaan 19, 2845 Niel, Belgium
Our Address
Our Mailbox
+32 3 369 17 40
Our Phone
© 2021 eTheRNA | Studio Hanswijk