GMP-certified quality control laboratory since 2021

Certificate of GMP compliance

• GMP-compliant analyses according to AMG §14 Para. 4 No. 3
• Compliance with EU GMP Guide (Parts 1, 2 and 4, and applicable annexes and documents of Part 3)
• Method validation according to ICH Q2, Q3A and Q3B
• Stability programs according to ICH Q1A and Q1B
• Analyses according to pharmacopoeia including verifications (Pharm. Eur. and USP)
• Physical separation of critical activities to avoid cross-contamination (e.g. separate weighing room for reference standards)
• Sample analysis in compliance with validated standard test methods or test instructions
• Documented chain of custody from sample receipt to disposal
• Team with many years of expertise in GMP and with products in different development phases
• QM system designed to respond flexibly to customer requests
• Support for newcomer customers with best-practice know-how

Innovative services for method development, qualification and validation

Axolabs performs the following ICH-compliant services with qualified state-of-the-art equipment:

• Robust method development
• Qualification and validation of reliable analytical methods 
• Development and transfer of analytical methods for characterization of oligonucleotide and mRNA Drug Substance and Drug Product
• Phase appropriate qualification and validation of analyte-specific analytical methods in accordance with pharmacopoeias and guidelines

Customized and analyte-specific solutions for GMP release analytics and characterization of oligonucleotides

We offer certified oligonucleotide and mRNA analytics in accordance with ICH guidelines, EU GMP guidelines and German AMWHV. All services are also available as non-GMP.

• High-end analytical solutions for various excipients (LNPs), Drug Substances and Drug Products for human use
• Release testing of Drug Substance and Drug Product
• ICH-compliant stability studies of Drug Substance and Drug Product
• Stress test / Forced Degradation studies

Axolabs offers direct access to all oligonucleotide- and mRNA-related techniques and analytical methods. 

Oligonucleotide Drug Substance  

• uHPLC for IP-RP, AEX and SEC chromatography for determination of identity, purity / impurities profile, assay
• HRMS / LCMS for identity confirmation
• MS/MS sequence confirmation
• UV/VIS spectroscopy for assay and melting point determination
• Moisture determination by Karl-Fischer titration 
• Sodium content determination by AES
• Endotoxin testing (LAL assay)
• Solubility and viscosity testing

Further tests are carried out with a reliable provider:

• Bioburden testing (TAMC/TYMC)
• Residual solvents by Headspace GC-FID
• Elemental impurities by ICP-MS

Oligonucleotide Drug Product  

In addition, the following tests may be offered for the Drug Product:

• Extractable Volume  
• Homogeneity
• Osmolality
• pH
• Assay by UV/VIS or uHPLC 

Stability and Storage

• Qualified stability chambers for ICH-compliant stability studies
  
  • - 80 °C ± 20 °C
  • - 20 °C ± 5 °C 
  • 5 °C ± 3 °C 
  • 25 °C ± 2 °C / 60% ± 5% relative air humidity
  • 40 °C ± 2 °C / 75% ± 5% relative air humidity
• Forced degradation including photosensitivity testing
• Terminal sterilization testing