Parenteral administration is often the route of choice for delivering oligonucleotide-based therapeutics. The oligonucleotide-based drug is first screened for its stability and compatibility in liquid form using dedicated chromatographic methods. For an increase in stability or prolongation of shelf-life, Eurofins CDMO also offers development into freeze-dried drug products. Here, the focus is divided between finding an optimal formulation to reach a stable lyophilised cake and optimising the lyophilisation cycle.

Lipid nanoparticles have been of keen interest for the past number of decades. Eurofins CDMO partners with clients to optimise lipid nanoparticle formulation of mRNA, siRNA or pDNA. Do not only get to know the stability of your incorporated oligonucleotide but monitor the lipid LNP composition in your formulation with our state-of-the-art analytics including High Resolution Mass Spectrometry.

The diverse nature of oligonucleotide therapeutics, modified with new chemical moieties, increases the complexity of impurity profiling which presents analytical challenges. Developing and manufacturing oligonucleotide-based therapeutics requires identification and quantification of both process related impurities, such as n-1 shortmers, and product related impurities, e.g., oxidation, deamination and depurination. To monitor these different critical quality attributes multiple separation methods or detection systems are required. Our chromatography and mass spectrometry capabilities enable the characterisation and quantification of components of drug products, accelerating your drug programme in accordance with regulatory guidelines and expectations.

Our analytical services include method development, subsequent method qualification and validation according to ICH guidelines, drug product release testing, and stability studies.