Analytical services for nucleic acid therapeutics
From discovery up to GMP production we follow your clinical trial candidate
Our capabilities
Based on the ExoReady process, we have predeveloped an analytical toolkit. However, if required, we are fully equipped to perform custom analytical services.
At Exothera, our analytical services cover DNA, RNA and LNPs analysis from discovery to preclinical and clinical phases and include quality control during GMP manufacturing.
We offer analytical capabilities during the development and manufacture of our solutions, and also offer this as a separate service.
We can help you
- develop new analytical methods or adapt specific analytical methods to your product
- perform routine analysis of R&D samples based on our standard analytical qualified methods catalog
- analyze GMP samples based on our QC’s validated method catalog
- validate new analytical methods or specific methods adapted to your product
Our testing methods
We provide a comprehensive list of methods to ensure the quality and safety of your candidate.
Drug substance |
Analyte |
Method |
mRNA identity | Nanopore sequencing |
mRNA content | Ribogreen spectrofluorimetry |
mRNA integrity | FA Cap electroph |
Capping efficiency | HPLC-UV |
dsRNA | ELISA |
In vitro expression | HEK Transfection/ELISA |
Residual proteins | µBCA |
Residual pDNA | qPCR |
Sterility | Compendial |
Bioburden | Compendial |
Endotoxins | Compendial |
Appearance | Compendial |
pH | Compendial |
Drug product |
Analyte |
Method |
Encapsulation yield | Ribogreen spectropfluorimetry |
LNP size/PDI | Dynamic Light Scattering |
Lipid content | HPLC-CAD |
Lipid degradation | HPLC-CAD |
Cytotoxicity | CKK8 |
pH | Potentiometry |
Osmolality | Freezing-point depression |
Endotoxins | LAL |
Sterility | Compendial |
Bioburden | Compendial |
Endotoxins | Compendial |
Appearance | Compendial |
pH | Compendial |
For any additional information
Please contact us and we will respond quickly!
Our capabilities
The need for custom analytics is greatly reduced thanks to our optimal ExoReady process. Our process is optimized so that all enzymes, DNA, etc. are at the accurate concentration to give high yield and reduce byproducts (dsRNA), excess or DNA/enzymes. Because there are less potential contaminants, it reduces the need for custom analytics and allows for great time savings.
Based on the ExoReady process, we have predeveloped an analytical toolkit. However, if required, we are fully equipped to perform custom analytical services.
At Exothera, our analytical services cover DNA, RNA and LNPs analysis from discovery to preclinical and clinical phases and include quality control during GMP manufacturing.
We offer analytical capabilities during the development and manufacture of our solutions, and also offer this as a separate service.
We can help you
- develop new analytical methods or adapt specific analytical methods to your product
- perform routine analysis of R&D samples based on our standard analytical qualified methods catalog
- analyze GMP samples based on our QC’s validated method catalog
- validate new analytical methods or specific methods adapted to your product
Our testing methods
Drug substance |
Analyte |
Method |
mRNA identity | Nanopore sequencing |
mRNA content | Ribogreen spectrofluorimetry |
mRNA integrity | FA Cap electroph |
Capping efficiency | HPLC-UV |
dsRNA | ELISA |
In vitro expression | HEK Transfection/ELISA |
Residual proteins | µBCA |
Residual pDNA | qPCR |
Sterility | Compendial |
Bioburden | Compendial |
Endotoxins | Compendial |
Appearance | Compendial |
pH | Compendial |
Drug product |
Analyte |
Method |
Encapsulation yield | Ribogreen spectropfluorimetry |
LNP size/PDI | Dynamic Light Scattering |
Lipid content | HPLC-CAD |
Lipid degradation | HPLC-CAD |
Cytotoxicity | CKK8 |
pH | Potentiometry |
Osmolality | Freezing-point depression |
Endotoxins | LAL |
Sterility | Compendial |
Bioburden | Compendial |
Endotoxins | Compendial |
Appearance | Compendial |
pH | Compendial |