ANALYTICS

Analytical services from discovery up to GMP production

Our capabilities 

 

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

Our capabilities 

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