GLP-certified test site since 2015 (updated 2024)
GCP-compliance confirmed by regulatory inspection in 2019

Bioanalytics of oligonucleotides and mRNA

• Bioanalytical method development and validation under GLP/GCP standards in accordance with: 
  • EMA guideline on the validation of bioanalytical methods
  • US FDA Guidance for Industry for Bioanalytical Method Validation
  • ICH M10 Guideline on Bioanalytical Method Validation and Study Sample Analysis (currently being amended) 
• All equipment and systems used in bioanalytical GLP/GCP tests are fully qualified/validated
• Separation of critical activities to avoid cross-contamination (e.g. separate weighing room for reference standards)
• Study sample analysis in compliance with all relevant guidelines and SOPs according to the validated standard test instructions

PNA-HPLC assay

Axolabs has a unique and proprietary assay system for the sensitive detection of oligonucleotides from biological matrices.

• Assay established in regulated environment (GLP/GCP), support from early development up to Clinical Phase 2 trials
• Extraction-free and robust procedure with the option of parallel detection of multiple analytes
• Assay compatible with conjugates and different oligonucleotide chemistries
• Simultaneous detection of metabolites
• Detection of 5’-phosphorylation of siRNAs as a marker for cytoplasmic delivery 

LC-MS/MS assay

Axolabs also offers an alternative assay for specific quantification of oligonucleotides from biological matrices. 

• The LC-MS/MS assay is the method of choice in order to quantify DNA- or RNA-based therapeutics and their metabolites from biological matrices with high specificity.
• The state-of-the-art triple quadrupole mass spectrometer enables multiple reaction monitoring (MRM) and therefore high sensitivity.
• Generic extraction procedures (applying solid-phase extraction or liquid-liquid-extraction or a combination of both) for antisense oligonucleotides (ASOs), aptamers and small interfering RNAs (siRNAs) allow quick method development for several analytes in various liquid and solid matrices.
• LC-MS/MS also allows a smooth simultaneous detection and quantification of the antisense and the sense strands of a siRNA.
• Beside parent compound quantification, metabolite identification (full scan MS method) can be performed using the same purified sample.
• The LC-MS/MS assay is currently offered in a non-regulated environment. 

 Axolabs plans to offer LC-MS/MS bioanalysis in accordance with the ICH M10 guideline by Q1 2025.

Content determination of test item dosages

• Content determination of oligonucleotides in test item formulations by UV/Vis spectrophotometry or uHPLC
• Method validated according to ICH Q2 (R2)