Analytics GMP/non-GMP 

Oligonucleotide, mRNA and Nucleic Acid Analysis

Characterization of single-stranded and double-stranded oligonucleotides by state-of-the-art mass spectrometry, HPLC and UPLC techniques

  • Method development
  • Established procedures for technology transfer to CMOs

Physicochemical and thermodynamic characterization of oligonucleotides (e.g. differential scanning calorimetry, temperature dependent UV-spectroscopy, extinction coefficient determination)

Oligonucleotide stability in biological matrices (liquid and solid)

Identification of oligonucleotide metabolites by LC/MS

mRNA identity

Characterization of nucleosides and nucleotides

Analysis of nucleic acid-protein interactions by Micro Scale Thermophoresis (MST), e.g. for the determination of dissociation constants (Kd) between oligonucleotides and target proteins (e.g. immune cell receptor, plasma proteins like HSA)

GMP-Compliant Oligonucleotide and mRNA Release and Stability Analysis

GMP-compliant analysis and release of excipients, active ingredients (drug substance) and medicinal products (regular and investigational drug products) for human use (GMP Certificate)

Analytical methods/equipment:

  • Oligonucleotide and mRNA purity and identity by UPLC with ESI-MS detection (Thermo TripleQuad and OrbiTrap for High-Resolution-MS)
  • Temperature-controlled UV spectroscopy
  • Lipid characterization by UHPLC with UV and CAD detection
  • LNP characterization by Malvern particle sizer
  • Nucleic acid encapsulation by fluorescence spectrometer
  • Water determination by Karl-Fischer, pH, osmolarity
  • Stability chambers for ICH-compliant stability studies