GMP Grade RNA
GMP certified since 2018, eTheRNA manufacturing is your trusted provider of GMP-grade RNA. With over 30 years of research grade mRNA manufacturing and more than 5 years of GMP mRNA production and development experience, we have the expertise to meet your needs and the capacity to respond rapidly.
Contact us to discuss your project, and download our GMP-grade RNA Buyer’s Guide which explains everything you need to know about purchasing GMP RNA.
Our Capabilities:
We can manufacture any RNA to GMP-grade that can be produced by in vitro transcription, such as:
- mRNA
- Long RNA
- Guide RNA
Size range: Approximately 200 nucleotides to >10 000 nucleotides.
Modifications: Our RNA can be made using regular or modified NTP’s, and with different cap-analog options.
Whether you’re ready to order GMP-grade RNA or looking for process development support, contact us today. We have the skills and experience to adapt your process for GMP production.
Upstream processing:
We offer various options for the purification of linearized pDNA and in vitro transcription with co-transcriptional capping and poly-adenylation, or alternatively enzymatic capping and/or poly-adenylation. We can also optimize conditions for your specific construct.
Downstream processing:
Depending on your use and quality requirements, we offer various options for purification of your RNA, including:
- Precipitation
- dsRNA reduction
- Column chromatography
- Tangential flow filtration
- Bioburden reduction
- Sterile filtration
Our formulation options:
We can formulate multiple APIs with water for injection (WFI), enabling further processing up to Drug Product.
Alternatively, we offer Lipid Nanoparticles (LNPs) formulation for targeted delivery and biodistribution.
Our fill-finish options:
For APIs, we offer filling in 50 ml tubes, using AT-Closed vials or through a closed system in sterile bags.
For IMPs, we offer filling in 2 ml AT-Closed vials, conducted aseptically and semi-automated.
Our GMP release process:
Batch release is completed according to cGMP. If and when the batch can be released, we formalize this in the Certificate of Analysis and the Certificate of Conformity, which is signed off by our Qualified Person.
Why work with us?
- Over 30 years of research grade mRNA manufacturing, and more than 5 years of GMP mRNA production experience
- Our processes are scalable, from mg to multi gram level
- We produce all RNA in our GMP-certified lab to your specification and according to clinical phrase-appropriate controls
GMP Grade RNA specifications
We offer the following specification options according to the specific regulatory requirements of your project:
- Visual inspection
- Appearance
- Integrity
- Identity
- pDNA content
- Protein content
- Endotoxin content
- Concentration
- Potency
- Sterility
- RNA sequence
