Currently, cGMP manufacturing of oligonucleotide therapeutics is operated at our facility in Petaluma, California. Another plant in Berlin, Germany, will be commissioned in 2025.

For cGMP manufacturing inquiries please write an email to: business.development@axolabs.com

Capabilities in Petaluma

Manufacturing

In Petaluma drug substances are produced in a 2,600 sqft manufacturing suite with two cGMP production lines, using GE OligoPilot 100, 400 or OligoProcess oligonucleotide synthesizers in quantities ranging from fractions of an mmol up to 300 mmol.   

Purification

For purification, skids from GE or YMC LEWA are used alongside with GE ÄKTA Flux 6 or Uniflux 120 TFF skids, for lyophilization one of two Millrock EPIC freeze dryers.  

The GMP suite is supported by 6,250 sqft of Process/Analytical Development and cGMP Quality Control laboratories.  

Analytical development & quality control

Our team of analytical scientists develop, qualify and validate analytical methodology used for physico-chemical characterization of raw materials, in-process-control samples, drug substance release and stability testing.

Process development

Our Process Development scientists develop and scale-up a wide range of therapeutic oligonucleotide modalities using DoE and QbD principles to ensure a robust well characterized manufacturing process.

Capabilities in Berlin (starting in 2025)

Manufacturing 

• 3 pilot-scale and 1 process-scale cGMP manufacturing suites for oligonucleotide therapeutics
• Segregated unit operations minimising risk of cross-contamination
• Use of Water for Injection (WfI) throughout all manufacturing steps minimising risk of microbiological contamination
• Process development and process optimisation                      
• Economic process scale-up and technology transfer
• Technical engineering batches
• Clinical batches
• Commercial batches 
• Single batch sizes of up to 500 g (pilot), and up to 10 kg (process)

Analytics and characterisation

• Molecule-specific analytical development
• Technology transfer
• Phase-appropriate qualification and validation of analytical methods
• GMP-compliant analytical testing 
• CMC support