GLP/GCP Services

GLP-certified test site since 2015
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 





QuantiGene™-Singleplex Assay (bDNA-branched DNA)

  • Sensitive and extraction-free mRNA quantification 
  • Quantification of therapeutic mRNAs from tissue against a reference standard
  • Parallel quantitative detection of therapeutic oligonucleotide and target mRNA from a single sample possible 
  • Assay established in regulated environment (GLP/GCP) 

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)