ANALYTICS

Analytical services for nucleic acid therapeutics

From discovery up to GMP production we follow your clinical trial candidate 

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 analytical services cover DNA, RNA and LNPs analysis

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
Our analytical services cover DNA, RNA and LNPs analysis with different methods

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 team of expert provides analytical services cover DNA, RNA and LNPs analysis

    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