CRO and CDMO services for oligonucleotide and RNA therapeutics from development to cGMP production
Axolabs GmbH
Kulmbach · Berlin · Petaluma (USA)New on Amplifa
About Axolabs
Axolabs GmbH is an integrated contract research and contract manufacturing organization (CRO/CDMO) for nucleic acid therapeutics such as siRNA, antisense oligonucleotides (ASO), sgRNA, aptamers and bioconjugates. The company accompanies projects from lead identification and in-silico sequence design through preclinical screening, GLP-compliant bioanalysis and process development to cGMP production for clinical Phases I–III and initial commercial supply. Manufacturing is performed by solid-phase oligonucleotide synthesis at the milligram to kilogram scale, including conjugations (GalNAc, peptides, lipids, antibodies) and LNP formulation services. cGMP manufacturing is carried out dual-site at the Berlin and Petaluma (USA) locations on synthesis platforms from Cytiva (OligoPilot™, OligoProcess™) as well as Asahi Kasei Bioprocess (AKB THESYS™ Synth100/Synth1500). Customers come from biotechnology, the pharmaceutical industry and academic research. Axolabs emerged in 2000 as Ribopharma AG and has been part of the LGC Group since 2017.
- Site
- Kulmbach
- Processes
- In-silico design & bioinformatics (sequence design, off-target analysis), Solid-phase oligonucleotide synthesis (multiple scales, high-throughput 96-well platforms), On-resin and post-synthetic conjugation (GalNAc, peptides, lipids, carbohydrates, antibodies), Pilot to commercial large-scale oligonucleotide manufacturing (mg to kg, non-GMP to GMP), cGMP production of nucleic acid therapeutics (clinical Phases I–III, initial commercial, Process development & synthesis scale-up (QbD/DoE), GMP analytics & quality control (uHPLC, LC-MS/MS, AEX, RP, SEC, release testing, impurity, GLP-compliant bioanalysis (PNA assay/HPLC, LC-MS/MS, MRM quantification, cytokine profiling)
- Materials
- siRNA, ASO (antisense oligonucleotides), sgRNA, Aptamers, Bioconjugates, mRNA, Chemically modified oligonucleotides, Custom CPG supports
- Certificates
- cGMP production (Phases I–III, initial commercial), GLP-compliant bioanalysis
- Founded
- 2000 (as
- Industries
- Biotechnology, Pharmaceutical industry, Nucleic acid therapeutics, Academic research, Nucleic acid therapeutics (siRNA, ASO, sgRNA, aptamers), Venture capital
- 01
In-silico design & bioinformatics
- 02
Lead identification & chemistry optimization
- 03
Solid-phase oligonucleotide synthesis
- 04
Conjugation
- 05
Preclinical screening & cell-based evaluation
- 06
GLP bioanalysis
- 07
Process development & scale-up (QbD/DoE)
- 08
cGMP production
- 09
GMP analytics & release testing
- 10
Technology transfer
Modalities & Product Classes
siRNA
Short interfering RNA for RNAi therapeutics, synthesized from research to cGMP batch.
Antisense oligonucleotides
Chemically modified single-stranded oligonucleotides for clinical and commercial projects.
sgRNA
Guide RNAs for genome editing applications, including chemical modifications.
Aptamers
Folding oligonucleotides with binding function, synthesized at research and GMP scale.
Bioconjugates
On-resin or post-synthetic conjugation with GalNAc, peptides, lipids, carbohydrates or antibodies.
mRNA
Analytical characterization and LNP formulation services for mRNA constructs.
Chemically modified oligonucleotides
Proprietary chemistries and custom CPG supports for stability, reduced immunogenicity and targeted cell screening.
Locations & Facilities
Kulmbach
DECRO: discovery, bioinformatics, bioanalysis
- Lot size
- mg–g
- Materials
- Oligonucleotides, mRNA
- High-throughput 96-well synthesis platforms
- PNA-HPLC
- LC-MS/MS
- qPCR
- xCELLigence®
- Flow cytometry
Berlin
DECDMO: pilot & large-scale cGMP production
- Part weight / size
- mg–kg
- Lot size
- Pilot to commercial scale
- Materials
- siRNA, ASO, sgRNA, aptamers, conjugates
- Cytiva OligoPilot™
- Cytiva OligoProcess™
- AKB THESYS™ Synth100
- AKB THESYS™ Synth1500
- uHPLC
- LC-MS/MS
Petaluma
USCDMO: GMP oligonucleotide production
- Part weight / size
- mg–kg
- Lot size
- Pilot to large-scale
- Materials
- siRNA, ASO, oligonucleotide conjugates
- Cytiva OligoPilot™
- Cytiva OligoProcess™
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| In-silico design & bioinformatics (sequence design, off-target analysis)Engineering | – | – | – | – | Oligonucleotides, RNA |
| Solid-phase oligonucleotide synthesis (multiple scales, high-throughput 96-well platforms)Other | – | – | – | – | siRNA, ASO, sgRNA, Aptamers, chemically modified oligonucleotides, Conjugates (GalNAc, peptide, lipid) |
| On-resin and post-synthetic conjugation (GalNAc, peptides, lipids, carbohydrates, antibodies)Other | – | – | – | – | Oligonucleotides |
| Pilot to commercial large-scale oligonucleotide manufacturing (mg to kg, non-GMP to GMP)Other | – | – | mg – kg | – | siRNA, ASO, Aptamers, complex oligonucleotides, Conjugates, chemically modified oligonucleotides |
| cGMP production of nucleic acid therapeutics (clinical Phases I–III, initial commercialOther | – | – | – | – | ASO, siRNA, sgRNA, Aptamers, Bioconjugates |
| Process development & synthesis scale-up (QbD/DoE)Engineering | – | – | – | – | Oligonucleotides |
| GMP analytics & quality control (uHPLC, LC-MS/MS, AEX, RP, SEC, release testing, impurityTesting | – | – | – | – | Oligonucleotides |
| GLP-compliant bioanalysis (PNA assay/HPLC, LC-MS/MS, MRM quantification, cytokine profiling)Testing | – | – | – | – | Oligonucleotides, Metabolites |
| mRNA analyticsTesting | – | – | – | – | mRNA |
| LNP formulation servicesOther | – | – | – | – | Lipid nanoparticles, mRNA |
| Preclinical screening (multiplex assays, QuantiGene™, qPCR, RNA-Seq, high-throughput screening)Testing | – | – | – | – | Oligonucleotides |
| Cell-based evaluation (xCELLigence®, flow cytometry, cytotoxicity, immunostimulation)Testing | – | – | – | – | Oligonucleotides |
| Integrated technology transfer (pilot to commercial scale)Engineering | – | – | – | – | Oligonucleotides |
4 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Oligonucleotide synthesis platform | Cytiva OligoPilot™ | – | – | – | Berlin, Germany / Petaluma, USA |
| Oligonucleotide synthesis platform | Cytiva OligoProcess™ | – | – | – | Berlin, Germany / Petaluma, USA |
| Oligonucleotide synthesis platform | Asahi Kasei Bioprocess AKB THESYS™ Synth100 | – | – | – | Berlin, Germany |
| Oligonucleotide synthesis platform | Asahi Kasei Bioprocess AKB THESYS™ Synth1500 | – | – | – | Berlin, Germany |
Additional services
Reference customers
Quality & Analytics
GMP manufacturing takes place at dual-site locations in Berlin and Petaluma with comprehensive analytics (uHPLC, LC-MS/MS, AEX, RP, SEC), in-line process monitoring (UV, conductivity), impurity profiling and release testing in accordance with regulatory requirements. The CRO bioanalysis is GLP-compliant.
| Evidence | Berlin | Petaluma |
|---|---|---|
| cGMP production (Phases I–III, initial commercial) | ||
| GLP-compliant bioanalysis |
History
- 2000
Foundation of Ribopharma AG by Dr. Roland Kreutzer and Dr. Stefan Limmer – the first company worldwide focused on RNAi therapeutics.
- 2003
Merger of Ribopharma AG with Alnylam Pharmaceuticals Inc.
- 2007
Spin-off of Alnylam Europe AG; establishment of Roche Kulmbach GmbH as a Center of Excellence for RNA therapeutics.
- 2011
Establishment of Axolabs GmbH through a management buy-out of the assets of Roche Kulmbach GmbH.
- 2017
Acquisition of Axolabs GmbH by the LGC Group; opening of the Petaluma, USA site.
- 2018
First GMP oligonucleotide batch at the Petaluma site.
- 2025
Expansion with the pilot and large-scale cGMP production site Berlin (partnership with Asahi Kasei).
- 2026
Evaluation agreement with Codexis for the ECO Synthesis Manufacturing Platform.